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ImportanceIn cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reported by investigators rather than by patients. There is increasing interest to collect symptomatic AE data via patient-reported outcome (PRO) questionnaires, but it is unclear whether it is feasible to implement this approach in multicenter trials.ObjectiveTo examine whether patients are willing and able to report their symptomatic AEs in multicenter trials.Design, setting, and participantsA total of 361 consecutive patients enrolled in any 1 of 9 US multicenter cancer treatment trials were invited to self-report 13 common symptomatic AEs using a PRO adaptation of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) via tablet computers at 5 successive clinic visits. Patient adherence was tracked with reasons for missed self-reports. Agreement with clinician AE reports was analyzed with weighted κ statistics. Patient and investigator perspectives were elicited by survey. The study was conducted from March 15, 2007, to August 11, 2011. Data analysis was performed from August 9, 2013, to March 21, 2014.ResultsOf the 361 patients invited to participate, 285 individuals enrolled, with a median age of 57 years (range, 24-88), 202 (74.3%) female, 241 (85.5%) white, 73 (26.8%) with a high school education or less, and 176 (64.7%) who reported regular internet use (denominators varied owing to missing data). Across all patients and trials, there were 1280 visits during which patients had an opportunity to self-report (ie, patients were alive and enrolled in a treatment trial at the time of the visit). Self-reports were completed at 1202 visits (93.9% overall adherence). Adherence was highest at baseline and declined over time (visit 1, 100%; visit 2, 96%; visit 3, 95%; visit 4, 91%; and visit 5, 85%). Reasons for missing PROs included institutional errors in 27 of 48 (56.3%) of the cases (eg, staff forgetting to bring computers to patients at visits), patients feeling "too ill" in 8 (16.7%), patient refusal in 8 (16.7%), and internet connectivity problems in 5 (10.4%). Patient-investigator CTCAE agreement was moderate or worse for most symptoms (most κ

BackgroundAbiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival in patients with metastatic castration-resistant prostate cancer after chemotherapy. We evaluated this agent in patients who had not received previous chemotherapy.MethodsIn this double-blind study, we randomly assigned 1088 patients to receive abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. The coprimary end points were radiographic progression-free survival and overall survival.ResultsThe study was unblinded after a planned interim analysis that was performed after 43% of the expected deaths had occurred. The median radiographic progression-free survival was 16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone (hazard ratio for abiraterone-prednisone vs. prednisone alone, 0.53; 95% confidence interval [CI], 0.45 to 0.62; P

Electronic patient-reported outcome (ePRO) applications promise great added value for improving symptom management and health-related quality of life. The aim of this narrative review is to describe the collection and use of ePROs for cancer survivorship care, with an emphasis on ePRO-symptom monitoring. It offers many different perspectives from research settings, while current implementation in routine care is ongoing. ePRO collection optimizes survivorship care by providing insight into the patients' well-being and prioritizing their unmet needs during the whole trajectory from diagnosis to end-of-life. ePRO-symptom monitoring can contribute to timely health risk detection and subsequently allow earlier intervention. Detection is optimized by automatically generated alerts that vary from simple to complex and multilayered. Using ePRO-symptoms during in-hospital consultation enhances the patients' conversation with the health care provider before making informed decisions about treatments, other interventions, or self-management. ePRO(-symptoms) entail specific implementation issues and complementary ethics considerations. The latter is due to privacy concerns, digital divide, and scarcity of adequately representative data for particular groups of patients. [ABSTRACT FROM AUTHOR]

To understand the relationship between patient experience, as measured by scores on the Consumer Assessment of Healthcare Providers and Systems (CAHPS®) survey, and clinical and financial outcomes among older cancer survivors. We analyzed the records of all Fee-for-Service (FFS) Medicare beneficiaries 66 years and older who completed one CAHPS survey from 2001 to 2004 or 2007–2013 with one of the five following cancer types: breast, bladder, colorectal, lung, or prostate; and completed a CAHPS survey within 5 years of cancer diagnosis date. We conducted a multivariate analysis, controlling for clinical and demographic variables, to evaluate the association between excellent CAHPS scores and the following clinical and financial outcomes: mortality, emergency department visits, and total healthcare expenditures. A total of 7395 individuals were present in our cohort, with 57% being male and 85.7% non-Hispanic White. Breakdown of the cohort by cancer site is as follows: prostate (40.4%), breast (28.6%), colorectal (14.0%), lung (9.4%), and bladder (7.6%). When looking at the relationship between CAHPS scores and clinical outcomes, there was no significant difference between excellent and non-excellent CAHPS score respondents in all three of the clinical outcomes studied. Furthermore, there was no association between ED utilization and patient experience scores when stratifying by cancer site and race/ethnicity among this cohort. In this cohort, a highly rated patient experience, as measured by responses on the CAHPS survey, is not associated with improved clinical outcomes among older cancer survivors. [ABSTRACT FROM AUTHOR]

Background: In the current study, the authors investigated the incidence of moderate to severe chemotherapy‐induced peripheral neuropathy (CIPN) for chemotherapy regimens commonly used in current clinical practice for the treatment of patients with early breast cancer. Patient‐reported and clinician‐assessed CIPN severity scores were compared, and risk factors for CIPN severity were identified. Methods: Patients completed a Patient‐Reported Symptom Monitoring form and oncologists completed a Common Terminology Criteria for Adverse Events form. CIPN reports were collected prospectively during regularly scheduled infusion visits throughout the duration of chemotherapy. Results: The sample included 184 women with a mean age of 55 years; approximately 73% were white. The 4 chemotherapy regimens used were doxorubicin and cyclophosphamide plus paclitaxel (60 patients); docetaxel and cyclophosphamide (50 patients); docetaxel, carboplatin, and anti–human epidermal growth factor receptor 2 (HER2) (24 patients); and doxorubicin and cyclophosphamide plus paclitaxel and carboplatin (18 patients). All patients treated with doxorubicin and cyclophosphamide plus paclitaxel and doxorubicin and cyclophosphamide plus paclitaxel and carboplatin received paclitaxel; all patients treated with docetaxel and cyclophosphamide and docetaxel, carboplatin, and anti‐HER2 received docetaxel. The chemotherapy dose was reduced in 52 patients (28%); in 15 patients (29%), this reduction was due to CIPN. Chemotherapy was discontinued in 26 patients (14%), 8 because of CIPN. Agreement between patient‐reported and clinician‐assessed CIPN severity scores was minimal (weighted Cohen kappa, P = .34). Patient‐reported moderate to severe CIPN was higher for paclitaxel (50%) compared with docetaxel (17.7%) (P < .001). Pretreatment arthritis and/or rheumatism (relative risk [RR], 1.58; 95% CI, 1.06‐2.35 [P = .023]) and regimens containing paclitaxel (RR, 2.88; 95% CI, 1.72‐4.83 [P < .0001]) were associated with higher CIPN severity. Being married (RR, 0.57; 95% CI, 0.37‐0.887 [P = .01]) was found to be associated with lower CIPN severity. Conclusions: The discrepancy between patient‐reported and clinician‐assessed CIPN underscores the need for both patient and clinician perspectives regarding this common, dose‐limiting, and potentially disabling side effect of chemotherapy. The severity of patient‐reported chemotherapy‐induced peripheral neuropathy (CIPN) varies by the regimen used in current clinical practice for the treatment of early breast cancer. The discrepancy between patient‐reported and clinician‐assessed CIPN underscores the need for both patient and clinician perspectives on this common, dose‐limiting, and potentially disabling side effect of chemotherapy. [ABSTRACT FROM AUTHOR]

OBJECTIVES: The impact of occupational therapy (OT) and physical therapy (PT) on functional outcomes in older adults with cancer is unknown. DESIGN: Two‐arm single‐institution randomized controlled trial of outpatient OT/PT. SETTING: Comprehensive cancer center with two off‐site OT/PT clinics. PARTICIPANTS: We recruited adults 65 years and older with a recent diagnosis or recurrence of cancer within 5 years, with at least one functional limitation as identified by a geriatric assessment. Participants were randomized to OT/PT or usual care. INTERVENTION: Rehabilitation consisted of individualized OT and PT that addressed functional activities and strength/endurance needs. MEASUREMENTS: Primary outcome was functional status as measured by the Nottingham Extended Activities of Daily Living scale. Secondary outcomes were Patient‐Reported Outcomes Measurement Information System‐Global Mental Health (GMH) and Global Physical Health (GPH), ability to participate in Social Roles (SR), physical function, and activity expectations and self‐efficacy (Possibilities for Activity Scale [PActS]). RESULTS: Among those recruited (N = 63), only 45 patients (71%) were evaluable due to loss of follow‐up and/or nonreceipt of intervention. The median age was 74 years; 53% were female, and 91% were white. Overall, 30% patients had hematologic malignancies, 30% breast cancer, and 16% colorectal cancers. A total of 65% were in active treatment; 49% had stage 3 or 4 disease. At follow‐up, both OT/PT (P = .02) and usual care (P = .03) groups experienced a decline in functional status. PActS scores between groups (P = .04) was significantly improved in the intervention group. GMH and SR met criteria for minimally important clinical difference favoring the intervention, but not statistical significance. Several barriers were noted in the implementation of the intervention program: recruitment, concerns about cost, distance, scheduling, and limited treatment provided. CONCLUSION: OT/PT may positively influence activity expectations and self‐efficacy. Future research needs to address significant barriers to implementation to increase use of OT/PT services and access to quality care. J Am Geriatr Soc 67:953–960, 2019. [ABSTRACT FROM AUTHOR]

Objective: To identify patient characteristics associated with sleep disturbance and worsening of sleep in individuals diagnosed with localized colorectal cancer and assess heterogeneity in these relationships.Methods: Data were from the MY-Health study, a community-based observational study of adults diagnosed with cancer. Patient-Reported Outcomes Measurement Information System® Sleep Disturbance, Anxiety, Depression, Fatigue, and Pain Interference measures were administered. Participants self-reported demographics, comorbidities, and treatment information. Regression mixture and multiple regression models were used to evaluate the relationship between sleep disturbance and patient characteristics cross-sectionally at an average of 10 months after diagnosis (n = 613) as well as change in sleep disturbance over a 6-month period (n = 361).Results: Pain, anxiety, fatigue, and the existence of multiple comorbid conditions had statistically significant relationships with sleep disturbance (B = 0.09, 0.22, 0.29, and 1.53, respectively; P < 0.05). Retirement (B = -2.49) was associated with sleep quality in the cross-sectional model. Worsening anxiety (B = 0.14) and fatigue (B = 0.20) were associated with worsening sleep disturbance, and more severe sleep disturbance 10 months after diagnosis (B = -0.21) was associated with improvement in sleep quality after diagnosis (P < 0.05). No evidence of latent subgroups of patients (heterogeneity) was present.Conclusions: Pain, anxiety, fatigue, employment, and comorbid conditions were associated with sleep disturbance, but regression coefficients were small (< |2.5|). Results suggest that screening for anxiety, depression, fatigue, or pain is not sufficient for identifying sleep disturbance. Given the negative consequences of sleep disturbance, sleep disturbance screening may be warranted. [ABSTRACT FROM AUTHOR]

Purpose There is increasing interest to use patient-reported outcome (PRO) measures to evaluate symptomatic adverse events (AEs) in cancer treatment trials. However, there are currently no standard recommended approaches for integrating patient-reported AE measures into trials. Methods Approaches are identified from previous trials for selecting AEs for solicited patient reporting, administering patient-reported AE measures, and analyzing and reporting results. Findings Approaches for integrating patient-reported AE measures into cancer trials generally combine current standard methods for clinician-reported AEs and established best practices for using PRO measures. Specific AEs can be selected for a PRO questionnaire based on common and expected reactions in a given trial context, derived from literature review and qualitative/mixed-methods evaluations and should be the same set administered across all arms of a trial. A mechanism for collecting unsolicited patient-reported AEs will also ideally be included. Patients will preferably report at baseline and at the end of active treatment as well as on a frequent standardized schedule during active treatment, such as weekly from home, with a recall period corresponding to the frequency of reporting (eg, past 7 days). Less frequent reporting may be considered after an initial intensive monitoring period for trials of prolonged treatments and during long-term follow-up. Electronic PRO data collection is preferred. Backup data collection for missed PRO reports is advisable to boost response rates. Analysis can use a combination of approaches to AE and PRO data. If a high proportion of patients is experiencing baseline symptoms, systematic subtraction of these from on-study AEs should be considered to improve reporting of symptoms related to treatment. More granular longitudinal analyses of individual symptoms can also be useful. Implications Methods are evolving for integrating patient-reported symptomatic AEs into cancer trials. These methods are expected to further evolve as more data from trials become available. [ABSTRACT FROM AUTHOR]

BACKGROUND Pain palliation resulting from antitumor therapy provides direct evidence of treatment benefit when combined with evidence of antitumor activity. The US Food and Drug Administration (FDA) previously issued guidance regarding the use of patient-reported outcome (PRO) measures to support labeling claims. The purpose of this article is to identify common challenges and key design strategies when measuring pain palliation in antitumor therapy clinical trials that are consistent with PRO Guidance principles. METHODS Antitumor clinical protocols submitted to the FDA between 1995 and 2012 that included pain palliation as a primary or secondary endpoint were reviewed. Challenges in critical trial design components were identified. Design strategies consistent with PRO Guidance principles are proposed. RESULTS The challenges identified were measurement of pain intensity and analgesic use, enrollment eligibility criteria, data collection methods, responder definitions, missing data, and blinding. Strategies included the use of well-defined, reliable, PRO assessments of pain intensity and analgesics; ensuring that enrollment criteria define patients with clinically significant pain attributable to cancer on an optimal analgesic regimen; defining responders using both pain and analgesic use criteria; incorporating an analysis of tumor response to support evidence of pain response; and minimizing missing data and inadvertent unblinding. CONCLUSIONS Improvement in cancer-related pain resulting from antitumor therapy is an important treatment benefit that can support drug approval and labeling claims when adequately measured if study results demonstrate statistically and clinically significant findings. Sponsors are encouraged to discuss pain palliation assessment methods with the FDA early in and throughout product development. Cancer 2014;120:761-767. © 2013 American Cancer Society. [ABSTRACT FROM AUTHOR]

Historically, patient‐reported outcome measures assessing symptoms and physical functioning have not been included in quality‐of‐care assessments. This editorial accompanies Smith et al's article on the innovative Patient Reported Outcomes Symptoms and Side Effects Study methodology using the Commission on Cancer's Rapid Quality Reporting System, and it explores methodological advancements needed before patient‐reported outcome measures can be used as quality‐of‐care metrics. [ABSTRACT FROM AUTHOR]

The article presents an evidence-based systematic review of Echinacea by the Natural Standard Research Collaboration. Echinacea species are traditionally used for a range of infections and malignancies. The roots and herb of echinacea species have attracted recent scientific interest due to purported immune stimulant properties. Oral preparations for prevention and treatment of upper respiratory tract infections, are popular in Europe and the U.S. Echinacea purpurea herb is believed to be the most potent echinacea species for this indication. Studies of oral echinacea for genital herpes and radiation-associated toxicity remain inconclusive, although one study of a combination of echinacea, propolis and vitamin C in children has reported positive results. Echinacea species oral extracts has been frequently recommend by natural medicine experts for treatment of the common cold, and for other conditions requiring immune stimulation. Usually it is recommended for topical treatment of wounds.

Examines the use, mechanism of action and pharmacology of shark cartilage. Chemical composition of commercial shark cartilage; Therapeutic use of shark cartilage for cancer patients; Adverse effect of using shark cartilage.

The article emphasizes the need for reassessment of the compendia of off-label cancer drugs. Topics covered include the use by the U.S. Centers for Medicare & Medicaid Services (CMS) of third-party drug compendia to inform decisions for off-label drug coverage in oncology, the limited transparency about the creation of compendia and the potential conflicts of interest involved, and the lack of oversight of the existing compendia-based approach for drug coverage decisions.

Context: The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials.Objectives: This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version.Methods: From seven pediatric cancer hospitals, 51 adolescents (13-20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive interviews with retrospective probing were completed in age groups of 13-15 and 16-20 year olds. Proxies were interviewed independently.Results: In general, the 16-20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13-15 year olds had greater challenges completing the PRO-CTCAE.Conclusion: This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults. [ABSTRACT FROM AUTHOR]