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The construct validity of three variants of the Trail Making Test was investigated using 162 undergraduate psychology students. During a 3-week period, the Trail Making Test of the Delis—Kaplan Executive Function System, Comprehensive Trail Making Test, and Connections Task were administered in six possible orders. Using confirmatory factor analysis, a two-factor (sequencing, shifting) model was identified as the best fitting model for the data as an alternative to unitary and three-factor (sequencing, shifting, scanning) models. The two-factor structure was invariant across groups. A latent means structural analysis yielded no differences between the factor means for each of the groups, which indicates the absence of order effects and supports the interchangeable use of the three tests. The study proposes the use of alternate, equivalent tasks to help eliminate the effects of practice associated with serial assessment and should be replicated in a clinical sample. [ABSTRACT FROM PUBLISHER]

Purpose: Increased attention to improving a culture of belonging in clinical learning environments has led to various approaches to addressing microaggressions. However, most approaches in the literature focus on responding or reacting to microaggressions with insufficient attention to building trust before microaggressions might occur. Research on microaggressions in clinical learning environments suggests anticipatory or pre-emptive conversations about microaggressions may foster greater trust. In this study, the authors explored how diverse participants perceived the experience of anticipatory conversations about potential microaggressions. Overall, the authors sought to gain a deeper understanding of how pre-emptive and anticipatory conversations may influence an organization's approach to addressing microaggressions in clinical learning environments., Methods: The authors utilized constructivist grounded theory methodology and conducted individual qualitative interviews with 21 participants in an academic department within a larger health sciences center in the United States., Results: Findings suggest that anticipatory conversations about microaggressions were challenging due to existing norms in dynamic clinical learning and working environments. Participants shared that the idea of anticipating microaggressions elicited dissonance. Conversations about microaggressions could potentially be facilitated through leaders who role model vulnerability, organizational supports, and an individualized approach for each team member and their role within a complex hierarchical organization., Discussion: Anticipating and addressing microaggressions in clinical learning environments holds tremendous potential, however, any conversations about personal identity remain challenging in medical and healthcare environments. This study suggests that any attempts to address microaggressions requires attention to cultural norms within healthcare environments and the ways that hierarchical organizations can constrain individual agency., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2023 The Author(s).)

Background: A common method of pain assessment is the numerical rating scale, where patients are asked to rate their pain on a scale from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine". We hypothesize such language is suboptimal as it involves a test of a cognitive skill, imagination, in the assessment of symptom severity., Methods: We used a large-scale online research registry, ResearchMatch, to conduct a randomized controlled trial to compare the distributions of pain scores of two different pain scale anchors. We recruited adults located in the United States who reported a chronic pain problem (> 3 months) and were currently in pain. Participants were randomized in a 1:1 ratio to receive pain assessment based on a modified Brief Pain Inventory (BPI), where the anchor for a score of 10 was either "extremely severe pain", or the original BPI, with the anchor "pain as bad as you can imagine". Participants in both groups also answered additional questions about pain, other symptomatology and creativity., Results: Data were obtained from 405 participants for the modified and 424 for the original BPI. Distribution of responses to pain questions were similar between groups (all p-values ≥ 0.12). We did not see evidence that the relationship between pain score and the anchor text differed based on self-perceived creativity (all interaction p-values ≥ 0.2). However, in the key analysis, correlations between current pain assessments and known correlates (fatigue, anxiety, depression, current pain compared to a typical day, pain compared to other people) were stronger for "extreme" vs. "imaginable" anchor text (p = 0.005)., Conclusion: Pain rating scales should utilize the modified anchor text "extremely severe pain" instead of "pain as bad as you can imagine". Further research should explore the effects of anchors for other symptoms., (© 2023. The Author(s).)

Purpose: The GODDESS © tool was developed to assess Desmoid Tumor/Aggressive Fibromatosis (DT/AF) symptom severity and impact on patients' lives. This study evaluated GODDESS © 's cross-sectional and longitudinal measurement properties., Methods: The Phase 3, randomized placebo-controlled, DeFi study (NCT03785964) of nirogacestat in DT/AF was used to assess GODDESS © 's reliability, construct validity, responsiveness, and estimate of meaningful change thresholds (MCTs). Other patient-reported outcome (PRO) measures included Patient Global Impression of Severity (PGIS) in DT/AF symptoms, EORTC QLQ-C30, Brief Pain Inventory Short Form, and PROMIS Physical Function short-form 10a v2.0 plus 3 items., Results: DeFi participants (N = 142) had a median age of 34 years (range: 18-76) and were mostly female (64.8%), with extra-abdominal (76.8%) or intra-abdominal tumors (23.2%). The GODDESS © symptom/impact scales showed internal consistency at baseline, cycles 4 and 7 (Cronbach's α > 0.70) and test-retest reliability (intra-class correlation coefficient > 0.85). GODDESS © scales correlated moderately to highly with PRO measures capturing similar content and differentiated among PGIS and Eastern Cooperative Oncology Group groups. GODDESS © scales detected improvement over time. For the total symptom score, a 1.30-point decrease was estimated as the within-person MCT and a 1.00-point decrease as the between-group MCT. For the physical functioning impact score, estimated within- and between-group MCTs were 0.60-point and 0.50-point decreases, respectively. Few participants exhibited symptom worsening., Conclusion: GODDESS © was found to be reliable, valid, responsive, and interpretable as a clinical trial endpoint in the pooled sample of DT/AF patients. Estimated MCTs can be used to define responders and assess group-level differences in future, unblinded, efficacy analyses., Trial Registration Number and Registration Date: NCT03785964; December 24, 2018., (© 2023. The Author(s).)

In June 2021, the US Food and Drug Administration (FDA) released a draft guidance for industry on core patient-reported outcomes (PROs) and related considerations for instrument selection and trial design in registrational cancer clinical trials, building on prior communications about the use of PROs to assess efficacy and tolerability in oncology drug development. The International Society for Quality of Life Research (ISOQOL) Standards and Best Practices Committee led an initiative to draft a commentary about the guidance, focusing on its positive aspects and areas that would benefit from additional clarification and consideration. For comprehensiveness, the authors reviewed existing public comments on the draft guidance, and the commentary underwent a thorough review process through three ISOQOL Special Interest Groups (Psychometrics, Clinical Practice, and Regulatory and Health Technology Assessment Engagement) followed by the ISOQOL Board. The goal of this commentary is to situate this new and relevant guidance document within the context of recent regulatory efforts on PROs and highlight areas in which further work may ultimately benefit the field., (© 2023. The Author(s).)

Purpose: To determine whether treatment of anal high-grade squamous intraepithelial lesions (HSIL), vs active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV, the US National Cancer Institute funded the Phase III ANal Cancer/HSIL Outcomes Research (ANCHOR) clinical trial. As no established patient-reported outcomes (PRO) tool exists for persons with anal HSIL, we sought to estimate the construct validity and responsiveness of the ANCHOR Health-Related Symptom Index (A-HRSI)., Methods: The construct validity phase enrolled ANCHOR participants who were within two weeks of randomization to complete A-HRSI and legacy PRO questionnaires at a single time point. The responsiveness phase enrolled a separate cohort of ANCHOR participants who were not yet randomized to complete A-HRSI at three time points: prior to randomization (T1), 14-70 (T2), and 71-112 (T3) days following randomization., Results: Confirmatory factor analysis techniques established a three-factor model (i.e., physical symptoms, impact on physical functioning, impact on psychological functioning), with moderate evidence of convergent validity and strong evidence of discriminant validity in the construct validity phase (n = 303). We observed a significant moderate effect for changes in A-HRSI impact on physical functioning (standardized response mean = 0.52) and psychological symptoms (standardized response mean = 0.60) from T2 (n = 86) to T3 (n = 92), providing evidence of responsiveness., Conclusion: A-HRSI is a brief PRO index that captures health-related symptoms and impacts related to anal HSIL. This instrument may have broad applicability in other contexts assessing individuals with anal HSIL, which may ultimately help improve clinical care and assist providers and patients with medical decision-making., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: Radical cystectomy (RC) has the potential to impact health-related quality of life (HRQOL). Many patients who undergo RC are current or former smokers. To better inform preoperative patient counseling, we examined the association between smoking status and HRQOL after RC., Materials and Methods: A secondary analysis was performed on a prospective, longitudinal study (2008-2014) examining HRQOL in patients undergoing RC for bladder cancer. We analyzed 12 validated patient-reported outcome measures that focused on functional, symptomatic, psychosocial, and global HRQOL domains. Measures were collected pre-operatively and 3-, 6-, 12-, 18-, and 24-months postoperatively. For each HRQOL domain, we estimated the mean domain scores using a generalized estimation equation linear regression model. Each model included survey time, smoking status, and time-smoking interaction as covariates. Pairwise comparisons of current, former, and never smokers were estimated from the models., Results: Of the 411 patients available for analysis, 29% (n = 119) never smoked, 59% (n = 244) were former smokers, and 12% (n = 48) were current smokers. Over the follow-up period, never smokers compared to current smokers had better global QOL scores (mean difference = +8.9; 95% CI 1.3-16; p = 0.023) and lower pain levels (mean difference = -10; 95% CI -19 to -0.54; p = 0.036). Compared to current smokers, former smokers had marginal improvements in global QOL (+6.9 points) and pain (-7.5 points) during the follow-up period., Conclusions: Current smokers reported worse HRQOL recovery in the 24-months after RC. These findings can be used to counsel patients who smoke on recovery expectations., Competing Interests: Declaration of Competing Interest All authors have no financial disclosures to report., (Published by Elsevier Inc.)

Background: Patient-reported outcome measures for sexual health were often designed for research studies that included only heterosexual, partnered, and cisgender participants; as such, they may have limited applicability for clinical use among sexual and gender minority (SGM) individuals or those without a partner., Aim: We aimed to conduct cognitive interviews with SGM persons and heterosexual women to determine the readability, comprehension, and applicability of questionnaire items to assess sexual function among diverse sexual and gender identities., Methods: We conducted 4 rounds of cognitive interviews with 52 participants (28 SGM; 24 cisgender, heterosexual) who provided feedback on the comprehension and wording of questionnaire items and response scales. We used items from the Female Sexual Function Index (FSFI) and focused on establishing content validity of a modified measure. Participants made recommendations for changes to the questionnaire, which was iteratively revised between interview rounds. Two independent coders analyzed the transcripts using structural coding based on 5 predefined codes: satisfaction with item, specificity/language change needed, missing/suggested item, patient definitions of concepts, and confusion with item., Outcomes: Content validity., Results: After 3 rounds of cognitive interviews and revisions to the questionnaire, participants found the final version acceptable and understandable, thereby reaching thematic saturation and establishing content validity of the modified FSFI. Modifications included the following: replacing all instances of "sexual stimulation" and "intercourse" with "sexual activity (alone or with a partner)," broadening the definition of "vaginal penetration" beyond penile-vaginal penetration, and adding skip logic to include the option "no sexual activity." Participants identified missing concepts important to their sexual health, such as use of an external lubricant., Clinical Implications: The FSFI and similar questionnaires need to be adapted to broader clinical practice populations such that all persons' experiences are accurately reflected and assessed, ensuring that sexual health needs can be met more inclusively., Strength and Limitations: A strength of the study was using cognitive interviews engaging patient perspectives, which is considered the gold standard for establishing content validity. One limitation is that participants included predominantly White and highly educated women., Conclusion: Feedback from interviews supports modifying FSFI items and further psychometric testing, and future studies should evaluate the measure among racially and educationally diverse groups., (© The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Adjuvant anti-PD1 treatment improves relapse-free survival (RFS) but has not been shown to improve overall survival (OS) in melanoma and is associated with risks of immune-related adverse events (irAEs), some permanent. We identified factors patients consider in deciding whether to undergo adjuvant anti-PD1 treatment and assessed prospective health-related quality of life (HRQoL), treatment satisfaction, and decisional regret., Patients and Methods: Patients with stage IIIB-IV cutaneous melanoma and free of disease, were candidates for adjuvant anti-PD1 immunotherapy, and had not yet discussed adjuvant treatment options with their oncologist were eligible. Participants viewed a 4-minute informational video tailored to their disease stage which communicated comprehensive, quantitative information about the risk of relapse both with and without adjuvant treatment, and risks of each irAE before deciding whether or not to opt for adjuvant therapy. We collected data on demographics, HRQoL, and attitudes toward adjuvant treatment over 1 year., Results: 14/34 patients (41%) opted for adjuvant anti-PD1 immunotherapy, 20/34 (59%) opted for observation. Patients choosing adjuvant immunotherapy scored higher on HRQoL social well-being at pre-treatment, were more likely to endorse positive statements about adjuvant immunotherapy, and to perceive that their physician preferred adjuvant therapy. They had lower decisional regret and higher satisfaction, even if they experienced toxicity or recurrence., Conclusions: When provided with comprehensive quantitative information about risks and benefits of adjuvant anti-PD1 immunotherapy, 20/34 (59%) of patients opted for observation. Patients choosing adjuvant immunotherapy had lower decisional regret and higher satisfaction over time even if they had poorer outcomes in treatment., (© The Author(s) 2023. Published by Oxford University Press.)

Background: Lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ+) individuals experience discrimination throughout the care continuum, including during serious illness and at end of life. High-quality palliative care requires that health professionals deliver individualized services that reflect the needs, experiences, and preferences of LGBTQ+ persons., Aim: To identify and appraise existing evidence related to the needs, experiences, and preferences for palliative and end of life care among LGBTQ+ individuals with serious illness., Design: Data-based convergent synthesis design reported per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines., Data Sources: PubMed, Embase, Cochrane CENTRAL, PsycINFO, CINAHL, and Scopus from January 1, 2010 to November 6, 2020., Results: Of 4875 results captured, 69 articles underwent full-text review and 13 were retained for analysis. Most studies were from North America with trans individuals represented in 10 of 13 studies. Needs ( n  = 6) included increased social support, institutional safety, economic and legal supports, and advocacy to mitigate health barriers.Experiences ( n  = 12) were driven by fear and worry associated with discrimination/stigma,providers' hetero-/cisnormative assumptions, homophobia and transphobia, social isolation, and an undignified death. Preferences ( n  = 6) pertained to inclusion of chosen families in decision-making, disclosure of LGBTQ+ identity based on safety of the clinical environment, and a desire to maintain autonomy., Conclusions: The robustness of the science has improved regarding the needs, experiences, and preferences of trans individuals. Actionable, inclusive policies coupled with sustained and integrated cultural sensitivity training for health workers are mandatory. Interventional research is critical to enhance tailored palliative care for LGBTQ+ people and their chosen families.

Purpose. To evaluate patient perceptions of a Web-based decision aid for the treatment of localized prostate cancer. Methods. We assessed patient perceptions of a multicomponent, Web-based decision aid with a preference elicitation/values clarification exercise using adaptive conjoint analysis, the generation of a summary report, and provision of information about localized prostate cancer treatment options. Using a think-aloud approach, we conducted 21 cognitive interviews with prostate cancer patients presented with the decision aid prior to seeing their urologist. Thematic content analysis was used to examine patient perceptions of the tool's components and content prior to engaging in shared decision making with their clinician. Results. Five themes were identified: 1) patients had some negative emotional reactions to the tool, pointing out what they perceived to be unnecessarily negative framing and language used; 2) patients were forced to stop and think about preferences while going through the tool and found this deliberation to be useful; 3) patients were confused by the tool; 4) patients tried to discern the intent of the conjoint analysis questions; and 5) there was a disconnect between patients' negative reactions while using the tool and a contrasting general satisfaction with the final "values profile" created by the tool. Conclusions. Studies are needed to explore the disconnect between patients' expressing negative reactions while going through some components of decision aids but satisfaction with the final output. In particular, we hypothesize that this effect might be explained by cognitive biases such as choice-supportive bias, hindsight bias, and the "IKEA effect." This is one of the first projects to elicit patient reactions while they were completing a decision aid, and we recommend further similar, qualitative postprocess evaluation studies., Highlights: We explored perceptions of a decision aid with education about localized prostate cancer treatment and preference elicitation using adaptive conjoint analysis.Patients found the tool useful but were also confused by it, tried to discern the intent of the questions, and expressed negative emotional reactions.In particular, there was a disconnect between patients' negative reactions while using the tool and general satisfaction with the final values profile generated by the tool, which is an area for future research., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Andrew J. Vickers is a co-inventor of the 4Kscore, a commercially available reflex test for predicting prostate biopsy. He receives royalties from sales of the test. He owns stock options in Opko, which offers the test. The remaining authors have nothing to disclose. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Financial support for this quality improvement project was provided by the Movember Foundation. The authors’ work on this article was supported through a National Institute of Health/National Cancer Institute Cancer Center Support Grant (P30-CA008748) to Memorial Sloan Kettering Cancer Center. S.V.C. was further supported by a National Institutes of Health/National Cancer Institute Transition Career Development Award (K22-CA234400). The funding agreement ensured the authors’ independence in designing the project, interpreting the data, writing, and publishing the report. This work was previously presented at the Society for Medical Decision Making (SMDM) virtual meeting 2020., (© The Author(s) 2023.)

Background: Due to the nature of their disease, patients with multiple myeloma (MM) often have bone disease-related pain that limits physical activity and diminishes health-related quality of life (HRQOL). Digital health technology with wearables and electronic patient reported outcome (ePRO) tools can provide insights into MM HRQoL., Methods: In this prospective observational cohort study conducted at Memorial Sloan Kettering Cancer in NY, NY, USA, patients with newly diagnosed MM (n = 40) in two cohorts (Cohort A - patients <65 years; Cohort B - patients ≥65 years) were passively remote-monitored for physical activity at baseline and continuously for up to 6 cycles of induction therapy from Feb 20, 2017 to Sep 10, 2019. The primary endpoint of the study was to determine feasibility of continuous data capture, defined as 13 or more patients of each 20-patient cohort compliant with capturing data for ≥16 h of a 24-hr period in ≥60% of days of ≥4 induction cycles. Secondary aims explored activity trends with treatment and association to ePRO outcomes. Patients completed ePRO surveys (EORTC - QLQC30 and MY20) at baseline and after each cycle. Associations between physical activity measurements, QLQC30 and MY20 scores, and time from the start of treatment were estimated using a linear mixed model with a random intercept., Findings: Forty patients were enrolled onto study, and activity bioprofiles were compiled among 24/40 (60%) wearable user participants (wearing the device for at least one cycle). In an intention to treat feasibility analysis, 21/40 (53%) patients [12/20 (60%) Cohort A; 9/20 (45%) Cohort B] had continuous data capture. Among data captured, overall activity trended upward cycle over cycle for the entire study cohort (+179 steps/24 h per cycle; p = 0.0014, 95% CI: 68-289). Older patients (age ≥65 years) had higher increases in activity (+260 steps/24 h per cycle; p < 0.0001, 95% CI: -154 to 366) compared to younger patients (+116 steps/24 h per cycle; p = 0.21, 95% CI: -60 to 293). Activity trends associated with improvement of ePRO domains, including physical functioning scores (p < 0.0001), global health scores (p = 0.02), and declining disease burden symptom scores (p = 0.042)., Interpretation: Our study demonstrates that feasibility of passive wearable monitoring is challenging in a newly diagnosed MM patient population due to patient use. However, overall continuous data capture monitoring remains high among willing user participants. As therapy is initiated, we show improving activity trends, mainly in older patients, and that activity bioprofiles correlate with traditional HRQOL measurements., Funding: Grants -National Institutes of HealthP30 CA 008748, Awards - Kroll Award 2019., Competing Interests: N.K. – Research Funding: Amgen, Janssen; Honoraria: CCO, Onc Live, Intellisphere; S.M. – Honoraria – MJH Life Sciences, Physician Education Resource, Research Funding – Fate Therapeutics, Juno Therapeutics (Bristol-Myers Squibb Company), Allogene Therapeutics, Janssen Oncology, Takeda, Advisory Board - Abbvie; H.H. - Consultancy – Novartis, Research Funding – Celgene/BMS, Takeda; E.S. - Patents/Royalties for CAR T cells to treat multiple myeloma, BMS; Consulting: BMS, Fate Therapeutics, Precision Biosciences; M.H. Research Funding – Daiichi Sankyo, GSK, Amgen, Abbvie, Beigene, Cosette, Consultancy – Intellisphere, GSK, BMS; U.S. - Honoraria – Physicians Education Resource; Research Funding - Celgene/Bristol Myers Squibb, Janssen, Parker Institute for Cancer Immunotherapy, American Society of Hematology Clinical Research Training Institute; C.T. – Research Funding- Janssen, Honoraria - Physician Educations Resource; B.D. – Sylvester K12 ACS IRG Pilot Grant, Consulting – Janssen, Honoraria – MJH, Advisory Board – Sanofi; G.S – Research Funding – Amgen, Janssen; M.S. – Research funding – Amgen, Angiocrine Bioscience, Omeros Corporation, Honoraria – Medscape LLC, i3Health; Advisory Board – Kite, Consulting - Omeros Corporation, Angiocrine Bioscience, O.L - MorphoSys; H.L. – Research Funding – Alexion, Takeda, Janssen, Consulting/Advisory board – Takeda, Pfizer, Janssen, Celgene, Caelum, Juno, Prothena, Legend Biotech USA, Abbvie, Karyopharm; S.G. Research Funding – Actinuum, Amgen, Takeda, Miltenyi, Johnson & Johnson, Celgene/BMS, Advisory Board – Amgen, Actinuum, Celgene, Takeda, Kite, Johnson & Johnson, Jazz Pharmaceutical, Novartis; Spectrum Pharmaceutical; S.Z.U. – Research Funding – Amgen, Array Biopharma, BMS, GSK, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, SkylineDX, Takeda, Consulting – Abbvie, Amgen, BMS, Celgene, EdoPharma, Genentech, Gilead, GSK, Janssen, Oncopeptides, Sanofi, Seattle Genetics, SecuraBio, SkylineDX, Takeda, Teneobio; O.L. – Research Funding - LLS, Rising Tide Foundation, NIH Sylvester Comprehensive Cancer Center's NCI Core Grant (P30CA240139), Riney Family Foundation, MMRF, IMF, Perelman Family Foundation, Amgen, Celgene, Janssen, Takeda, Glenmark, Seattle Genetics, Karyopharm; Honoraria for advisory boards for Adaptive, Amgen, Binding Site, BMS, Celgene, Cellectis, Glenmark, Janssen, Juno, Pfizer; and served on Independent Data Monitoring Committees (IDMC) for international randomized trials by Takeda, Merck, Janssen, Theradex; A.L. – Consulting/Honoraria - BMS, Janssen, Research Funding – BMS, Pfizer, Janssen; E.T., D.M, J.L. G.H., A.Z., M.S., D.C, A.D., T.M.A, P.S, F.K. declare no competing interests., (© 2023 The Author(s).)

Objective: The aim of this study was to describe the translation and psychometric testing of the Lung Cancer Screening Health Belief Scale (LCSHBS) into Spanish., Methods: The English version of the LCSHBS was professionally translated in accordance with best practices in the translation of patient-reported outcome tools. The independent certified professional translator completed a forward translation of the LCSHBS from English to Spanish, followed by a review of the translated questionnaire by a certified Memorial Sloan Kettering Cancer Center Spanish-English bicultural expert, who reviewed the scale for accuracy., Results: Initial testing of the scales is valid and reliable, and supports the Spanish version of the LCSHBS (LCSHBS-S). Internal consistency reliability of the scales was supported with Cronbach's ranging from 0.81 to 0.96. Construct validity was established with confirmatory factor analysis and testing for differences between individuals who have and have not screened in theoretically proposed directions. These newly translated scales can help investigators expand this research into the large Spanish-speaking lung screening-eligible population as they develop and test critical behavioural interventions to increase lung cancer screening in the at-risk population., Conclusions: Development of effective interventions to enhance shared decision-making about lung cancer screening between patients and providers must first identify factors influencing the individual's screening participation. Future efforts facilitating patient-provider conversations are better informed by understanding the perspective of the individual making the decision., (© 2022 John Wiley & Sons Ltd.)

Objectives: The Anal Cancer High-grade squamous intraepithelial lesions (HSIL) Outcomes Research (ANCHOR) Health-Related Symptom Index (A-HRSI) is a 25-item measure that assesses physical symptoms and impacts, and psychological symptoms. To promote generalizability and equity in the capture of these concepts in Spanish-speaking participants, we linguistically validated a Spanish version of A-HRSI., Methods: Following independent forward translation and reconciliation of A-HRSI from English to Spanish, two rounds of cognitive interviews were completed with ANCHOR participants who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish. Interviews were coded to highlight any items and concepts that were reported as being difficult for any reason by ≥ 3 participants, with such items revised during a research team panel discussion and tested in a second round of interviews if applicable., Results: Seventeen participants representing 8 nationalities were enrolled (Round 1 n=10, Round 2 n=7); 7 participants reported not completing high school (41.2%). No difficulties were reported with respect to the theoretical concepts measured by A-HRSI. We made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s)., Conclusion: The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL. Language is a tremendous barrier to enrolling patients to clinical trials. The anal cancer high-grade squamous intraepithelial lesions (HSIL) outcomes research [ANCHOR] trial is a randomized clinical trial that recently established that the treatment of anal HSIL, versus active monitoring, is effective in reducing incidence of anal cancer in persons living with HIV (PLWH). The ANCHOR Health-Related Symptom Index (A-HRSI) is a 25-item patient-reported outcomes measure that was developed to assess physical symptoms, physical impacts, and psychological symptoms related to anal HSIL. As approximately 10% of ANCHOR participants preferred the delivery of their healthcare in Spanish, the purpose of the present study was to linguistically validate a Spanish version of A-HRSI. Based on feedback from interviews with 17 participants from the ANCHOR trial who had been diagnosed with anal HSIL in the prior nine months and preferred delivery of their healthcare in Spanish, we made modifications to the Spanish translation of eight items and two response option terms in cases where participants had difficulty understanding a term, experienced problems in discriminating between terms, or preferred the use of an alternative term to represent the concept(s). The Spanish version of A-HRSI is a linguistically valid tool that can be used to assess physical symptoms, impacts, and psychological symptoms related to anal HSIL as part of clinical trials or routine care., (© 2022. The Author(s).)

Background: The importance of deriving benefit and meaning has been identified among cancer caregivers, but this has yet to be examined in the context of rare cancers. We sought to characterize unmet needs and experiences of caregivers of patients with Erdheim-Chester disease (ECD) and other histiocytic neoplasms (HN) and to identify factors associated with finding benefit and meaning-making in providing care for patients with rare cancers., Methods: Caregivers of patients with ECD and other HN completed quantitative surveys. Linear univariable regression modeling examined associations between unmet needs, social and family support, and intolerance of uncertainty with benefit finding and meaning-making. A subset participated in qualitative interviews assessing experiences of rare cancer caregiving that were analyzed with applied thematic analysis (NCT039900428)., Findings: Of caregivers ( N  = 92, M  = 54 years old, 68% female) of patients with ECD (75%) and other HN (25%), 78% reported moderately or severely unmet support needs, most frequently informational (58%) and psychological/emotional (66%) needs. Caregivers with unmet informational, psychological/emotional, and social support needs, difficulty tolerating uncertainty, a longer duration of the patient's illness, lower social support, more family conflict, and higher anxiety and depression symptoms demonstrated less benefit finding and meaning-making ( p s <.05). Qualitative interviews ( N  = 19) underscored information and support needs and the capacity to derive meaning from caregiving., Interpretation: Rare cancer caregivers report numerous unmet information and support needs, needs that arise from disease rarity itself and which are associated with diminished capacity for deriving benefit and meaning from caregiving. Findings highlight targets for interventions to improve support for caregivers with HN and other rare cancers., Funding: NIH P30 CA008748 (PI: Craig Thompson, MD), NIH T32 CA009461 (H.M.; PI: Jamie Ostroff, PhD), Frame Family Fund (E.L.D.), Applebaum Foundation (E.L.D.)., Competing Interests: Dr. Applebaum receives support from Blue Note Therapeutics. Dr. Diamond discloses unpaid editorial support from Pfizer Inc and serves on an advisory board for Day One Therapeutics and Springworks Therapeutics, both outside the submitted work and serves on the Histiocytosis Association Board of Trustees (unpaid) and Erdheim-Chester Disease Global Alliance -Medical Advisory Board (unpaid)., (© 2022 The Authors.)

Background: Depressive symptoms in patients with cancer are associated with poor quality of life and decreased survival. Although inflammation is reliably associated with depression in otherwise healthy individuals, the association in patients with cancer remains unclear. Given the high prevalence of cancer-related inflammation, the authors aimed to establish the relationship between inflammation and depression in cancer patients based on extant literature., Methods: A systematic review and meta-analysis was performed using Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines and registered under Prospero ID CRD42021226743. Three databases were searched including PubMed, the Cochrane Library, and PsycINFO using the following criteria for inclusion: 1) measurement of a peripheral inflammatory marker, 2) use of a validated tool/scale to measure depression, and 3) a cancer diagnosis. Risk of publication bias was assessed by Funnel plot and Egger test., Results: Seventy-three studies were included in the systematic review and 54 studies (n = 5017) were included in meta-analyses. Associations with depressive symptoms were significant for peripheral blood interleukin (IL)-6 (standardized mean difference [SMD] = 0.59; 95% confidence interval [CI], 0.35-0.82), I 2  = 57.9%; tumor necrosis factor (TNF) (SMD = 0.73; 95% CI, 0.35-1.11), I 2  = 74.1%; and C-reactive protein (CRP) (SMD = 0.57; 95% CI, 0.27-0.87), I 2  = 0%. IL-5, IL-13, albumin, and neutrophil-to-lymphocyte ratio were associated with depressive symptoms but based on fewer studies. Most cancer settings were represented; the number of studies per inflammatory marker varied from 1 to 52., Conclusions: Although peripheral inflammatory markers were unevenly studied, the most studied markers (IL-6, TNF, and CRP) were associated with depressive symptoms in cancer patients and may be useful for management of depressive symptoms in the cancer setting., Lay Summary: Peripheral blood inflammatory markers (IL-6, TNF, and CRP) were associated with depressive symptoms in various cancer settings. Although further studies are warranted, these findings may help identify and manage depressive symptoms in patients with cancer., (© 2022 American Cancer Society.)

Background: The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking., Methods: We conducted a phase 3 trial at 25 U.S. sites. Persons living with HIV who were 35 years of age or older and who had biopsy-proven anal HSIL were randomly assigned, in a 1:1 ratio, to receive either HSIL treatment or active monitoring without treatment. Treatment included office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod. The primary outcome was progression to anal cancer in a time-to-event analysis. Participants in the treatment group were treated until HSIL was completely resolved. All the participants underwent high-resolution anoscopy at least every 6 months; biopsy was also performed for suspected ongoing HSIL in the treatment group, annually in the active-monitoring group, or any time there was concern for cancer., Results: Of 4459 participants who underwent randomization, 4446 (99.7%) were included in the analysis of the time to progression to cancer. With a median follow-up of 25.8 months, 9 cases were diagnosed in the treatment group (173 per 100,000 person-years; 95% confidence interval [CI], 90 to 332) and 21 cases in the active-monitoring group (402 per 100,000 person-years; 95% CI, 262 to 616). The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test)., Conclusions: Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02135419.)., (Copyright © 2022 Massachusetts Medical Society.)

Objective: Among patients living with advanced, life-limiting illness, reconciling the prospect of disease progression with future goals and expectations is a key psychological task, integral to treatment decision-making and emotional well-being. To date, this psychological process remains poorly understood with no available measurement tools. The present paper develops and validates a measurement model for operationalizing this psychological process., Methods: In Phase 1, concept elicitation interviews were conducted among Stage IV lung, gastrointestinal, and gynecologic cancer patients, their caregivers, and experts (N = 19), to further develop our conceptual framework centered on assimilation and accommodation coping. In Phase 2, draft self-report items of common assimilation and accommodation coping strategies were evaluated via patient cognitive interviews (N = 11)., Results: Phase 1 interviews identified several coping strategies, some of which aimed to reduce the perceived likelihood of disease progression (assimilation), and others aimed to integrate the likelihood into new goals and expectations (accommodation). The coping strategies appeared to manifest in patients' daily lives, and integrally related to their emotional well-being and how they think about treatments. Phase 2 cognitive interviews identified items to remove and modify, resulting in a 31-item measure assessing 10 assimilation and accommodation coping strategies., Conclusions: The present work derived a content-valid measure of the psychological process by which patients reconcile the prospect of disease progression with their goals and expectations. Further psychometric validation and use of the scale could identify intervention targets for enhancing patient decision-making and well-being., (© 2022 John Wiley & Sons Ltd.)

Background: Technology acceptability and usage surveys (TAUS) are brief questionnaires that measure technology comfort, typical daily use, and access in a population. However, current measures are not adapted to low- and middle-income country (LMIC) contexts., Objective: The objective of this pilot study was to develop a TAUS that could be used to inform the implementation of a mobile health (mHealth) intervention in Nigeria., Methods: A literature review of validated technology comfort and usage scales was conducted to identify candidate items. The draft measure was reviewed for face validity by an expert panel comprised of clinicians and researchers with cultural, methodological, and clinical expertise. The measure was piloted by radiologists at an oncology symposium in Nigeria., Results: After expert review, the final measure included 18 items organized into 3 domains: (1) comfort with using mobile applications, (2) reliability of internet or electricity, and (3) attitudes toward using computers or mobile applications in clinical practice. The pilot sample (n=16) reported high levels of comfort and acceptability toward using mHealth applications in the clinical setting but faced numerous infrastructure challenges., Conclusions: Pilot results indicate that the TAUS may be a feasible and appropriate measure for assessing technology usage and acceptability in LMIC clinical contexts. Dedicating a domain to technology infrastructure and access yielded valuable insights for program implementation., (©Kathleen A Lynch, Thomas M Atkinson, Adeleye D Omisore, Olusola Famurewa, Olalekan Olasehinde, Oluwole Odujoko, Olusegun I Alatise, Adedeji Egberongbe, T Peter Kingham, Elizabeth A Morris, Elizabeth Sutton. Originally published in JMIR Formative Research (https://formative.jmir.org), 20.04.2022.)

Background: Accurate self-reported symptomatic toxicity documentation via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is essential throughout cancer treatment to ensure safety and understand therapeutic efficacy. However, the capture of accurate toxicities from patients undergoing radiation therapy is challenging because this is generally provided only at the time of scheduled visits., Objective: This study seeks to establish the usability and feasibility of a mobile PRO-CTCAE Administration System (mPROS) to capture toxicities related to radiation therapy., Methods: English-speaking adult patients who were undergoing radiation therapy for cancer were enrolled and given a brief demonstration of the Say All Your Symptoms (SAYS) and Symptom Tracking Entry Program (STEP) interfaces of the mPROS app, followed by a patient-use phase where patient actions were observed as they navigated mPROS to enter toxicities. Patient feedback was captured via a semistructured interview and brief questionnaire., Results: We enrolled 25 patients (age: mean 60.7 years; females: n=13, 52%; White patients: n=13; 52%; non-Hispanic patients: n=19, 76%; college graduates: n=17, 68%). Patients almost equally preferred the SAYS (n=14, 56%) or STEP (n=11, 44%) interfaces, with 21 patients (84%) agreeing that they would use mPROS to report their symptoms to their health care team and 19 patients (76%) agreeing that they would recommend mPROS to others., Conclusions: The mPROS app is usable and feasible for facilitating the patient reporting of radiation therapy-related symptomatic toxicities. A revised version of mPROS that incorporates patient input and includes electronic health record integration is being developed and validated as part of a multicenter trial., (©Jody Underwood, Susan McCloskey, Ann Raldow, Amar Kishan, Chad Zalkin, Daniel Navarro, Lisa Scott Holt, Andrew Webb, Kathleen A Lynch, Thomas M Atkinson. Originally published in JMIR Formative Research (https://formative.jmir.org), 12.04.2022.)

Background: Radical cystectomy (RC) has the potential for profound changes to health-related quality of life (HRQOL)., Objective: To evaluate a broad range of HRQOL outcomes in a large RC cohort., Design, Setting, and Participants: A single-center prospective study enrolled RC patients from 2008 to 2014. We collected 14 separate patient-reported outcome measures at the presurgical visit and at 3, 6, 12, 18, and 24 mo after RC., Outcome Measurements and Statistical Analysis: To visualize the patterns of recovery over time across domains, we used generalized estimating equations (GEEs) with nonlinear terms. Given substantial differences in patient selection for the type of urinary diversion, we separately modeled longitudinal HRQOL within conduit and continent diversion groups. The mean pre-RC scores were compared to illustrate the baseline HRQOL differences between diversion groups., Results and Limitations: The analyzed cohort included 411 patients (n = 205 ileal conduit, n = 206 continent diversion). At baseline, patients receiving continent diversion reported better mean physical (p < 0.001), urinary (p = 0.006), and sexual function (p < 0.001), but lower social function (p = 0.015). After RC, GEE modeling showed physical function scores decreasing 5/100 points by 6 mo, and subsequently stabilizing or returning to baseline. By 12 mo, social function improved by 10/100 points among continent diversions, while remaining stable among ileal conduits. Global quality of life exceeded baseline scores by 6 mo. Sexual function scores were low before RC, with limited recovery. Psychosocial domains were stable or improved, except for 10/100-point worsening of body image among ileal conduits., Conclusions: RC patients reported favorable HRQOL recovery within 24 mo in most areas other than body image (ileal conduits) and sexual function (both). Importantly, large measurable decreases in scores were not reported by 3 mo after RC. These contemporary outcomes and the excellent locoregional control provided by RC further support it as the gold standard therapy for high-risk bladder cancer., Patient Summary: We review quality of life in the 24 mo following radical cystectomy. Large decreases in health-related quality of life were not reported, with most areas returning to, or exceeding, baseline, except for sexual function and body image., (Copyright © 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Context: Depressive symptoms are prevalent and associated with greater healthcare utilization among hospitalized adults with cancer. Music therapy and massage therapy are available at many National Cancer Institute (NCI)-Designated Cancer Centers and recommended by the American Society of Clinical Oncology for depressive symptoms, but a paucity of studies have compared these two therapies., Objectives: We conducted a retrospective, multi-method program evaluation of single, first-time music therapy and massage therapy sessions delivered to hospitalized adults with cancer., Methods: The study was conducted at an NCI-Designated Comprehensive Cancer Center between February 2018 and October 2019. We assessed depressive symptoms with the Edmonton Symptom Assessment Scale (ESAS) depression item. We also invited patients to provide free-text comments describing their treatment experience., Results: Among 1764 patients (61.2% women, 72.7% white), 350 received music therapy and 1414 received massage therapy; music therapy was associated with a 0.4 point greater reduction (95% 0.3 to 0.6, P < 0.001) in the ESAS depression score relative to massage therapy. When analyses were restricted to the 452 (25.6%) patients with moderate-to-severe depressive symptoms (ESAS score ≥ 4), music therapy was associated with a 1.2 point greater reduction (95% CI 0.7 to 1.7, P < 0.001) relative to massage therapy, a clinically meaningful difference. In free-text comments, music therapy was described as energizing, uplifting, and evocative, whereas massage therapy was described as calming and relaxing., Conclusion: Among hospitalized adult cancer patients, both music therapy and massage therapy were associated with reduced depressive symptoms, but music therapy was associated with a greater reduction than massage therapy., (Copyright © 2021. Published by Elsevier Inc.)

Context: Among patients with advanced life-limiting illness, an inaccurate understanding of prognosis is common and associated with negative outcomes. Recent years have seen an emergence of new interventions tested for their potential to improve prognostic understanding. However, this literature has yet to be synthesized., Objectives: To identify and characterize tested interventions, summarize intervention findings, and outline directions for future research., Methods: Systematic searches were conducted in five databases - PubMed/MEDLINE (NLM), EMBASE (Elsevier), CINAHL (EBSCO), PsycINFO (OVID), and Cochrane Central Register of Controlled Trials (Wiley) - to identify interventions evaluated within a randomized controlled design for their impact on prognostic understanding., Results: Of the 2354 initial articles, 12 were selected for final inclusion, representing nine unique interventions. Intervention types included decision aids accompanying medical consults, palliative care consultations, communication training for patients and physicians, and targeted discussions regarding prognosis and treatment decision making. Common components of interventions included provision of prognostic information, assistance with end-of-life care planning, and provision of decisional and emotional support during discussions. Most interventions were associated with some indication of improvement in prognostic understanding. However, even after intervention, inaccurate prognostic understanding was common, with 31-95 percent of patients in intervention groups exhibiting inaccurate perceptions of their prognosis., Conclusion: Prognostic understanding interventions hold the potential to improve patient understanding and thus informed decision making, but limitations exist. Future research should examine why many patients receiving intervention may continue to maintain inaccurate perceptions, and identify which intervention components can best enhance informed, value-consistent decision making., (Copyright © 2021. Published by Elsevier Inc.)

Adolescents and young adults (AYAs) require a multidisciplinary approach to cancer care due to their complex biopsychosocial situations and varied developmental maturity. Currently, age and diagnosis determine referral to pediatric or adult oncology, with differing treatment paradigms and service utilization patterns, contributing to suboptimal improvements in outcomes. Understanding the unique perspectives of AYAs is essential to designing patient-centered AYA services. Thus, we conducted six focus groups with AYAs ( n = 25) treated by medical or pediatric oncologists to evaluate: (1) the unique experiences of cancer care as an AYA; (2) AYA-specific information needs and communication preferences; and (3) recommendations for service provision, delivery and accommodations for AYAs. Transcripts were analyzed using inductive thematic content analysis and identified six major themes to inform clinically-actionable recommendations and the development of a patient-reported outcome measure: (1) AYAs experience social isolation and loss of independence; (2) AYAs have an uncertain sense of the future and need conversations around survivorship and long-term and late effects; (3) AYAs desire greater control over discussions with their care team; (4) AYAs need additional navigational and social/caregiver supports; (5) AYAs prefer an inclusive AYA space in the hospital; and (6) LGBTQ+ patients experience distinct concerns as AYA cancer patients. These will form the basis for specific and tailored clinical recommendations to improve AYA cancer care delivery.

Background: Patient-reported outcome instruments to assess sexual functioning typically assume that patients are heterosexual and have a single sexual partner, thus they may have limited applicability for sexual and gender minority (SGM) populations as well as for nonpartnered individuals or those with multiple partners., Aim: To explore the perceptions of SGM persons regarding the Female Sexual Function Index (FSFI), a commonly used sexual functioning questionnaire., Methods: We conducted 2 rounds of cognitive interviews with 27 SGM persons with and without a cancer diagnosis. Interviews were audio-recorded and transcribed. Two researchers independently coded the transcripts using inductive thematic analysis to identify major themes., Outcomes: Themes identified via qualitative analysis., Results: Cognitive debriefing with the participants provided critical insights about the way we ask questions about sexual functioning in the oncology clinic. Three overarching themes arose from the data: (i) Certain aspects of the questionnaire were felt to unnecessarily medicalize sexuality; (ii) FSFI domains were perceived to represent a narrow and heteronormative experience of sexuality focused on penile-vaginal intercourse; (iii) Questionnaire domains emphasizing sexual "performance" were perceived as male-oriented., Clinical Implications: Questionnaires such as the FSFI that were developed in research studies with specific eligibility criteria need to be adapted to the broader population seen in clinical practice., Strengths & Limitations: Strengths of the study include purposive sampling of SGM persons through LGBTQ networks. Our sample included individuals of different sexual orientations, gender identities, marital status, and cancer histories. However, a limitation is that the the majority of the sample was white and college-educated. Other limitations of the study include the potential sampling bias of self-selected participants with a particular interest in the study questions., Conclusion: The findings provide important evidence for the development of a more inclusive sexual function measure, moving away from the traditional heteronormative, cisnormative approach to measuring sexual function. Austria MD, Lynch K, Le T, et al. Sexual and Gender Minority Persons' Perception of the Female Sexual Function Index. J Sex Med 2021;18:2020-2027., (Copyright © 2021 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Background: The Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) was developed to incorporate the patient's perspective into evaluation of clinical benefit in advanced non-small cell lung cancer trials and meet regulatory expectations for doing so. Qualitative evidence supported 7 items covering 5 symptom concepts., Objective: This study evaluated measurement properties of the NSCLC-SAQ's items, overall scale, and total score., Methods: In this observational cross-sectional study, a purposive sample of patients with clinician-diagnosed advanced non-small cell lung cancer, initiating or undergoing treatment, provided sociodemographic information and completed the NSCLC-SAQ, National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lung Symptom Index (FLSI-17), and a Patient Global Impression of Severity item. Rasch analyses, factor analyses, and assessments of construct validity and reliability were completed., Results: The 152 participants had a mean age of 64 years, 57% were women, and 87% where White. The majority were Stage IV (83%), 51% had an Eastern Cooperative Oncology Group performance status of 1 (32% performance status 0 and 17% performance status 2), and 33% were treatment naïve. Rasch analyses showed ordered thresholds for response options. Factor analyses demonstrated that items could be combined for a total score. Internal consistency (Cronbach  α = 0.78) and test-retest reliability (intraclass correlation coefficient = 0.87) were quite satisfactory. NSCLC-SAQ total score correlation was 0.83 with the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lung Symptom Index-17. The NSCLC-SAQ was able to differentiate between symptom severity levels and performance status (both P values < .001)., Conclusions: The NSCLC-SAQ generated highly reliable scores with substantial evidence of construct validity. The Food and Drug Administration's qualification supports the NSCLC-SAQ as a measure of symptoms in drug development. Further evaluation is needed on its longitudinal measurement properties and interepretation of meaningful within-patient score change. (Curr Ther Res Clin Exp. 2021; 82:XXX-XXX)., (© 2021 The Authors.)

Survivors of head and neck cancer (HNC) can have multiple health concerns. To facilitate their care, we developed and pilot-tested a clinical informatics intervention, HN-STAR. HN-STAR elicits concerns online from HNC survivors prior to a routine oncology clinic visit. HN-STAR then presents tailored evidence-based clinical recommendations as a clinical decision support tool to be used during the visit where the oncology clinician and survivor select symptom management strategies and other actions. This generates a survivorship care plan (SCP). Online elicitation of health concerns occurs 3, 6, and 9 months after the clinic visit, generating an updated SCP each time. HN-STAR encompasses important methods of improving survivorship care (e.g., needs assessment, tailored interventions, dissemination of guidelines) and will be evaluated in a pragmatic trial to maximize external validity. This hybrid type 1 implementation-effectiveness trial tests HN-STAR effectiveness while studying barriers and facilitators to implementation in community oncology practices within the National Cancer Institute Community Oncology Research Program. Effectiveness will be measured as differences in key survivorship outcomes between HNC participants who do and do not use HN-STAR over one year after the clinic visit. The primary endpoint is HNC-specific quality of life; other outcomes include patient-centered measures and receipt of guideline-concordant care. Implementation outcomes will be assessed of survivors, providers, and clinic stakeholders. The hybrid design will provide insight into a dose-response relationship between the extent of implementation fidelity and effectiveness outcomes, as well as how to incorporate HN-STAR into standard practice outside the research setting., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: To address the lack of validated patient-reported outcome (PRO) instruments that define and quantify patient expectations in thyroid cancer surgery, we developed and initially validated ThyroidEx, a novel disease-specific PRO instrument., Study Design: Survey study., Setting: Single-institution tertiary care cancer center., Methods: An expert panel drafted an initial set of thyroid cancer-specific concepts, which was used in semistructured concept elicitation interviews with patients with thyroid cancer 4 weeks before and 8 weeks after surgery. Candidate items were generated per patient responses and refined via cognitive interviewing and additional review by the expert panel. The draft ThyroidEx was then preoperatively administered to a separate cohort undergoing thyroid cancer surgery to establish a final item set and initial psychometric evidence., Results: Prospective concept elicitation interviews generated 358 patient-elicited concepts (n = 15 patients). These were then placed into 70 unique subcategories from which 41 items were generated for cognitive interviews with 20 patients preoperatively and 28 postoperatively. After expert panel review, ThyroidEx included 18 items across 2 scales (Expectations and Concerns), with an additional item about beliefs. In the preoperative cohort in phase 2 (n = 67), internal consistency Cronbach's α values ranged from 0.81 to 0.89. Descriptive analysis showed significant differences between patients' concerns and expectations and clinicians' perceptions., Conclusion: Defining expectations represents an important modifier in the measurement of PROs. Preliminary validation of ThyroidEx revealed incongruent expectations between expert opinion and patients. Future development and implementation of ThyroidEx may affect preoperative consultation and the consent process.

Context: Music therapy (MT) is a nonpharmacologic therapy where licensed therapists provide active (e.g., singing, playing songs) or passive (e.g., listening) music-based interventions. Both active and passive MT are effective techniques for treating cancer-related symptoms. However, the influence of active vs. passive MT techniques on patient-reported perceptions and experiences of care have yet to be explored., Objectives: To understand how active and passive MT is perceived and experienced by patients with cancer., Methods: We conducted a retrospective analysis of semistructured interviews collected as part of a quality improvement study (n = 20) with patients in the inpatient setting who had received active or passive MT within the past 24 hours. Transcripts were analyzed using thematic content analysis., Results: Four themes emerged: 1) Different articulations of benefit for recipients of active vs. passive MT; 2) patient choice as a form of empowerment; 3) changed perception of hospital experience; and 4) differing recommendations for future MT. Recipients of active MT emphasized the session's interactive elements, finding the sessions stimulating by providing opportunities for joyous social interaction not centered on their diagnosis. Passive MT recipients focused on the calming therapeutic effect of the session, easing anxieties through focus and reflection on the music itself., Conclusion: This analysis builds on current MT literature by providing insights specifically from oncology patients treated in the inpatient setting. Patients experience active and passive MT in different ways and perceived unique benefits for coping with cancer from each technique. Our findings can inform development of specific MT for symptom control in hospital settings., (Copyright © 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: COVID-19 increased stress levels while reducing access to mind-body services in patients with cancer. We describe the rapid deployment of remotely delivered mind-body services to people with cancer during COVID-19, rates of participation, and acceptability from patients' perspectives., Methods: Eligible participants were patients with cancer age ≥ 18 years enrolled in a single academic cancer center's online patient portal. Interventions included mind-body group therapy sessions in fitness, meditation, yoga, dance, tai chi, and music delivered using Zoom video conferencing. Sessions were 30-45 min and led by an integrative medicine clinician. Following each session, participants were asked to complete a three-item questionnaire assessing (1) satisfaction with the class session, (2) reduction in stress/anxiety, and (3) likelihood of recommending the class to others. Patients could also provide comments in real-time using the Zoom chat function., Results: Among 5948 unique visits, the most frequently attended classes were fitness (n = 2513, 42.2%) followed by meditation (n = 1176, 19.8%) and yoga (n = 909, 15.3%). Of these visits, 3902 (65.6%) had an associated completed questionnaire. Across class types, a large majority of participants reported being extremely satisfied (n = 3733, 95.7%), experiencing extreme reductions in anxiety/stress (n = 3268, 83.8%), and being extremely likely to recommend the class to others (n = 3605, 92.4%). Fitness had the highest endorsement among class types (all p values < 0.001). Themes from the chat responses included gratitude, expressions of helpfulness, and feelings of connection., Conclusion: High utilization of and satisfaction with these virtual mind-body services demonstrate the significant potential of remote delivery to facilitate patient access to services.

Background: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library designed for eliciting patient-reported adverse events in oncology. For each adverse event, up to three individual items are scored for frequency, severity, and interference with daily activities. To align the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events with other standardized tools for adverse event assessment including the Common Terminology Criteria for Adverse Events, an algorithm for mapping individual items for any given adverse event to a single composite numerical grade was developed and tested., Methods: A five-step process was used: (1) All 179 possible Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events score combinations were presented to 20 clinical investigators to subjectively map combinations to single numerical grades ranging from 0 to 3. (2) Combinations with <75% agreement were presented to investigator committees at a National Clinical Trials Network cooperative group meeting to gain majority consensus via anonymous voting. (3) The resulting algorithm was refined via graphical and tabular approaches to assure directional consistency. (4) Validity, reliability, and sensitivity were assessed in a national study dataset. (5) Accuracy for delineating adverse events between study arms was measured in two Phase III clinical trials (NCT02066181 and NCT01522443)., Results: In Step 1, 12/179 score combinations had <75% initial agreement. In Step 2, majority consensus was reached for all combinations. In Step 3, five grades were adjusted to assure directional consistency. In Steps 4 and 5, composite grades performed well and comparably to individual item scores on validity, reliability, sensitivity, and between-arm delineation., Conclusion: A composite grading algorithm has been developed and yields single numerical grades for adverse events assessed via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, and can be useful in analyses and reporting.

Background: The COVID-19 pandemic has transformed cancer care with the rapid expansion of telemedicine, but given the limited use of telemedicine in oncology, concerns have been raised about the quality of care being delivered. We assessed the patient experience with telemedicine in routine radiation oncology practice to determine satisfaction, quality of care, and opportunities for optimization., Patients and Methods: Patients seen within a multistate comprehensive cancer center for prepandemic office visits and intrapandemic telemedicine visits in December 2019 through June 2020 who completed patient experience questionnaires were evaluated. Patient satisfaction between office and telemedicine consultations were compared, patient visit-type preferences were assessed, and factors associated with an office visit preference were determined., Results: In total, 1,077 patients were assessed (office visit, n=726; telemedicine, n=351). The telemedicine-consult survey response rate was 40%. No significant differences were seen in satisfaction scores between office and telemedicine consultations, including the appointment experience versus expectation, quality of physician's explanation, and level of physician concern and friendliness. Among telemedicine survey respondents, 45% and 34% preferred telemedicine and office visits, respectively, and 21% had no preference for their visit type. Most respondents found their confidence in their physician (90%), understanding of the treatment plan (88%), and confidence in their treatment (87%) to be better or no different than with an office visit. Patients with better performance status and who were married/partnered were more likely to prefer in-person office visit consultations (odds ratio [OR], 1.04 [95% CI, 1.00-1.08]; P=.047, and 2.41 [95% CI, 1.14-5.47]; P=.009, respectively). Patients with telephone-only encounters were more likely to report better treatment plan understanding with an office visit (OR, 2.25; 95% CI, 1.00-4.77; P=.04)., Conclusions: This study is the first to assess telemedicine in routine radiation oncology practice, and found high patient satisfaction and confidence in their care. Optimization of telemedicine in oncology should be a priority, specifically access to audiovisual capabilities that can improve patient-oncologist communication.

Social scientists have advocated for the use of participatory research methods for Global Health project design and planning. However, community-engaged approaches can be time and resource-intensive. This article proposes a feasible framework for conducting a participatory needs assessment in time-limited settings using multiple, triangulated qualitative methods. This framework is outlined through a case study: a participatory needs assessment to inform the design of an ultrasound-guided biopsy training program in Nigeria. Breast cancer is the leading cause of death for Nigerian women and most cases in Nigeria are diagnosed at an advanced stage; timely diagnosis is impeded by fractious referral pathways, costly imaging equipment, and limited access outside urban centers. The project involved participant observation, surveys, and focus groups at the African Research Group for Oncology (ARGO) in Ile-Ife, Nigeria. Through this timely research and engagement, participants spoke about diagnostic challenges, institutional power dynamics, and infrastructure considerations for program implementation.

Purpose: Cancer-related fatigue is a prevalent, debilitating symptom that contributes to increased health care utilization among hospitalized patients. Music therapy is a nonpharmacological intervention that uses active (eg, singing, selecting songs) and passive (eg, listening) techniques. Preliminary evidence from small trials suggests a potential benefit for cancer-related fatigue in the inpatient setting; however, it remains unclear which techniques are most effective., Methods: A cross-sectional mixed-methods study was performed to compare cancer-related fatigue before and after active or passive music therapy. Cancer-related fatigue was captured via the Edmonton Symptom Assessment Scale fatigue item. Patients were asked to provide postsession free-text comments., Results: A total of 436 patients (mean [standard deviation] age, 62.2 [13.4] years; n = 284 [65.1%] women; n = 294 [67.4%] white; active music therapy n = 360 [82.6%]; passive music therapy n = 76 [17.4%]) with a range of primary malignancies participated. Active music therapy was associated with a 0.88-point greater reduction in cancer-related fatigue (95% CI, 0.26 to 1.51; P = .006; Cohen's D, 0.52) at postsession as compared with passive music therapy when restricting the analysis to patients who rated their baseline cancer-related fatigue as moderate to severe (ie, ≥ 4; n = 236 [54.1%]). Free-text responses confirmed higher frequencies of words describing positive affect/emotion among active music therapy participants., Conclusions: In a large sample of inpatient adults with diverse cancer disease types, active music therapy was associated with greater reduction in cancer-related fatigue and increased reporting of positive affect/emotions compared with passive music therapy. Additional research is warranted to determine the specific efficacy and underlying mechanisms of music therapy on cancer-related fatigue.

Purpose: The incidence of breast cancer is rising in Nigeria, and one major barrier to care is the lack of affordable and appropriate breast cancer diagnosis by ultrasound (US)-guided biopsy. The prohibitive cost of US devices limits their availability in low- and middle-income countries. The emergence of mobile health (mHealth) imaging devices may offer an acceptable low-cost alternative. The purpose of this research was to perform a comprehensive needs assessment to understand knowledge, use, training needs, and attitudes as regards image-guided biopsy in Nigeria to inform the development of an mHealth-based US-guided biopsy training program., Methods: A multistakeholder needs assessment was conducted at the Sixth Annual African Research Group for Oncology Symposium. Voluntary anonymous surveys were administered to all attendees. A subset of attendees (ie, surgeons, radiologists, pathologists, and nurses) participated in six focus groups. Survey items and interview guides were developed collaboratively with local and international input., Results: Surveys focusing on use, training needs, and attitudes regarding US-guided biopsies were completed with a 55% response rate (n = 54 of 98) among participants from 22 hospitals across Nigeria. Respondents expressed dissatisfaction with the way breast biopsies were currently performed at their hospitals and high interest in having their institution participate in a US-guided biopsy training program. Focus group participants (n = 37) identified challenges to performing US-guided procedures, including equipment functionality and cost, staff training, and access to consumables. Groups brainstormed the design of an mHealth US-guided biopsy training program, preferring a train-the-trainer format combining in-person teaching with independent modules., Conclusion: A multidisciplinary needs assessment of local stakeholders identified a need for and acceptability of an mHealth-based US-guided biopsy training program in Nigeria.

Research examining the experience of informal caregivers (ICs) for patients with rare cancers is limited. This was a mixed-methods pilot study of 14 ICs for patients with Erdheim-Chester disease (ECD), an ultra-rare neoplasm. Participants were predominantly female and over half provided at least 60% of their loved one's care. Participants completed measures of the impact of caregiving, caregiver burden, unmet needs, quality of life, anxiety, and depression. Participants reported substantial impact of caregiving, including limiting (50%) or discontinuing (21%) paid employment, and exhausting financial savings (43%). ICs reported a moderate level of burden with five (38%) reporting risk for burnout. While participants reported anxiety (64%) and depression (14%), their overall quality of life was favorable. Semi-structured interviews highlighted factors related to the distress and isolation of navigating a rare cancer. ECD ICs report burden and distress shaped by the experience of providing care for a patient with a rare cancer.

Purpose: Patient-reported outcome measures (PROMs) that assess how patients feel and function have potential for evaluating quality of care. Stakeholder recommendations for PRO-based performance measures (PMs) were elicited, and feasibility testing was conducted at six cancer centers., Methods: Interviews were conducted with 124 stakeholders to determine priority symptoms and risk adjustment variables for PRO-PMs and perceived acceptability. Stakeholders included patients and advocates, caregivers, clinicians, administrators, and thought leaders. Feasibility testing was conducted in six cancer centers. Patients completed PROMs at home 5-15 days into a chemotherapy cycle. Feasibility was operationalized as ≥ 75% completed PROMs and ≥ 75% patient acceptability., Results: Stakeholder priority PRO-PMs for systemic therapy were GI symptoms (diarrhea, constipation, nausea, vomiting), depression/anxiety, pain, insomnia, fatigue, dyspnea, physical function, and neuropathy. Recommended risk adjusters included demographics, insurance type, cancer type, comorbidities, emetic risk, and difficulty paying bills. In feasibility testing, 653 patients enrolled (approximately 110 per site), and 607 (93%) completed PROMs, which indicated high feasibility for home collection. The majority of patients (470 of 607; 77%) completed PROMs without a reminder call, and 137 (23%) of 607 completed them after a reminder call. Most patients (72%) completed PROMs through web, 17% paper, or 2% interactive voice response (automated call that verbally asked patient questions). For acceptability, > 95% of patients found PROM items to be easy to understand and complete., Conclusion: Clinicians, patients, and other stakeholders agree that PMs that are based on how patients feel and function would be an important addition to quality measurement. This study also shows that PRO-PMs can be feasibly captured at home during systemic therapy and are acceptable to patients. PRO-PMs may add value to the portfolio of PMs as oncology transitions from fee-for-service payment models to performance-based care that emphasizes outcome measures.