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•We describe a five-step process involving diverse stakeholders for developing a digital health intervention (SHIFT) to address sexual dysfunction in hematopoietic stem cell transplant (HSCT) survivors.•SHIFT incorporates medical information, educational materials, intimacy exercises, and activities to address the multiple etiologies of sexual health concerns in HSCT survivors.•SHIFT includes strategies to enhance app engagement including gamification, personalization, and incorporation of videos from HSCT survivors and clinicians.•The final prototype of SHIFT was initially acceptable to key stakeholders including HSCT survivors and transplant clinicians.

IMPORTANCE: Symptom monitoring interventions are increasingly becoming the standard of care in oncology, but studies assessing these interventions in the hospital setting are lacking. OBJECTIVE: To evaluate the effect of a symptom monitoring intervention on symptom burden and health care use among hospitalized patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTS: This nonblinded randomized clinical trial conducted from February 12, 2018, to October 30, 2019, assessed 321 hospitalized adult patients with advanced cancer and admitted to the inpatient oncology services of an academic hospital. Data obtained through November 13, 2020, were included in analyses, and all analyses assessed the intent-to-treat population. INTERVENTIONS: Patients in both the intervention and usual care groups reported their symptoms using the Edmonton Symptom Assessment System (ESAS) and the 4-item Patient Health Questionnaire-4 (PHQ-4) daily via tablet computers. Patients assigned to the intervention had their symptom reports displayed during daily oncology rounds, with alerts for moderate, severe, or worsening symptoms. Patients assigned to usual care did not have their symptom reports displayed to their clinical teams. MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of days with improved symptoms, and the secondary outcomes were hospital length of stay and readmission rates. Linear regression was used to evaluate differences in hospital length of stay. Competing-risk regression (with death treated as a competing event) was used to compare differences in time to first unplanned readmission within 30 days. RESULTS: From February 12, 2018, to October 30, 2019, 390 patients (76.2% enrollment rate) were randomized. Study analyses to assess change in symptom burden included 321 of 390 patients (82.3%) who had 2 or more days of symptom reports completed (usual care, 161 of 193; intervention, 160 of 197). Participants had a mean (SD) age of 63.6 (12.8) years and were mostly male (180; 56.1%), self-reported as White (291; 90.7%), and married (230; 71.7%). The most common cancer type was gastrointestinal (118 patients; 36.8%), followed by lung (60 patients; 18.7%), genitourinary (39 patients; 12.1%), and breast (29 patients; 9.0%). No significant differences were detected between the intervention and usual care for the proportion of days with improved ESAS-physical (unstandardized coefficient [B] = −0.02; 95% CI, –0.10 to 0.05; P = .56), ESAS-total (B = −0.05; 95% CI, –0.12 to 0.02; P = .17), PHQ-4–depression (B = −0.02; 95% CI, –0.08 to 0.04; P = .55), and PHQ-4–anxiety (B = −0.04; 95% CI, –0.10 to 0.03; P = .29) symptoms. Intervention patients also did not differ significantly from patients receiving usual care for the secondary end points of hospital length of stay (7.59 vs 7.47 days; B = 0.13; 95% CI, –1.04 to 1.29; P = .83) and 30-day readmission rates (26.5% vs 33.8%; hazard ratio, 0.73; 95% CI, 0.48-1.09; P = .12). CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that for hospitalized patients with advanced cancer, the assessed symptom monitoring intervention did not have a significant effect on patients’ symptom burden or health care use. These findings do not support the routine integration of this type of symptom monitoring intervention for hospitalized patients with advanced cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03396510

Treatment-related sexual dysfunction affects the majority of hematopoietic stem cell transplant (HSCT) survivors. Data regarding the relationship between sexual health domains and patient-reported quality of life (QOL) and psychological distress are limited, particularly in this population.

Background: Most men who die of prostate cancer are older than 70 years. The ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) randomized men of all ages with metastatic hormone-sensitive prostate cancer (mHSPC) to receive androgen deprivation therapy (ADT) with or without docetaxel demonstrating an overall survival (OS) benefit for docetaxel. Methods: In a post-hoc analysis of this trial, we assessed patient characteristics and OS in patients ≥70 years (“older men”) versus <70 years (“younger men”) with Cox proportional hazards models. In addition, we compared adverse events, therapy completion rate, and subsequent treatment patterns between these two groups using Chi-squared tests. Results: 177 (22.4%) patients were ≥70 years. Docetaxel + ADT resulted in improved OS in both older and younger men (Hazard Ratio [HR] 0.45, 95%CI: 0.25–0.80 for older men; HR 0.71, 95%CI: 0.53–0.95 for younger men). This treatment benefit was seen for subgroups of older men with high volume disease (HR 0.43, 95%CI 0.23–0.79) and de novo metastatic disease (HR 0.36, 95%CI 0.19–0.69). A similar proportion of older and younger men completed six cycles of docetaxel (82.6% vs. 87.1%, p= 0.28). Rates of grade 3–5 adverse events were similar between older and younger men (36.8% vs. 26.8%, respectively, p= 0.069). The rate of any Grades 4–5 adverse events did not differ significantly between older and younger men (14.9% vs. 11.9%, respectively, p= 0.46). In the control arm, a smaller proportion of older men received subsequent cancer treatments (34.4% vs. 51.5%, p= 0.017) or subsequent docetaxel (25.6% vs. 37.6%, p= 0.035) compared to younger men. Conclusions: Older men with mHSPC had similar OS benefit and clinical outcomes compared to younger men when receiving docetaxel + ADT. Oncologists should consider docetaxel chemotherapy as a favorable treatment option for older men with mHSPC who are fit for chemotherapy.

•The coronoavirus disease 19 (COVID-19) pandemic has not worsened pre-hematopoietic stem cell transplantation (HSCT) distress, fatigue, or quality of life.•However, it has had negative and positive implications in the recovery following HSCT.•The COVID-19 pandemic has been a barrier to needed social support for HSCT recipients.

An inpatient palliative care intervention during HCT led to improvement in patient QOL and mood. We sought to describe components of the intervention, investigate differences in supportive care practices by treatment arm, and explore whether these differences mediated the impact of the intervention on patient QOL and mood. We conducted a secondary analysis of a randomized trial investigating inpatient palliative care integrated with transplant care versus standard transplant care for HCT recipients. Palliative care clinicians completed weekly surveys to describe topics addressed during visits. We extracted use of supportive care medications from the medical record. Participants completed QOL and mood assessments at baseline and two weeks post-HCT. Causal mediation assessed whether differences in supportive care practices mediated the impact of the intervention on patient-reported outcomes. A total of 160 HCT recipients participated. Palliative care visits most frequently focused on managing symptoms and coping with HCT. Patients randomized to the intervention were more likely to use Patient-Controlled Analgesia (PCA) (32.1% vs. 15.2%, p= 0.02) and atypical antipsychotics (35.8% vs. 17.7%, p= 0.01). Neither PCA nor atypical antipsychotics mediated the effect of the intervention on patient-reported outcomes. Future work to explore mechanisms by which the palliative care intervention improves QOL and mood is needed.

IMPORTANCE: Patients with acute myeloid leukemia (AML) receiving intensive chemotherapy experience substantial decline in their quality of life (QOL) and mood during their hospitalization for induction chemotherapy and often receive aggressive care at the end of life (EOL). However, the role of specialty palliative care for improving the QOL and care for this population is currently unknown. OBJECTIVE: To assess the effect of integrated palliative and oncology care (IPC) on patient-reported and EOL outcomes in patients with AML. DESIGN, SETTING, AND PARTICIPANTS: We conducted a multisite randomized clinical trial of IPC (n = 86) vs usual care (UC) (n = 74) for patients with AML undergoing intensive chemotherapy. Data were collected from January 2017 through July 2019 at 4 tertiary care academic hospitals in the United States. INTERVENTIONS: Patients assigned to IPC were seen by palliative care clinicians at least twice per week during their initial and subsequent hospitalizations. MAIN OUTCOMES AND MEASURES: Patients completed the 44-item Functional Assessment of Cancer Therapy–Leukemia scale (score range, 0-176) to assess QOL; the 14-item Hospital Anxiety and Depression Scale (HADS), with subscales assessing symptoms of anxiety and depression (score range, 0-21); and the PTSD Checklist–Civilian version to assess posttraumatic stress disorder (PTSD) symptoms (score range, 17-85) at baseline and weeks 2, 4, 12, and 24. The primary end point was QOL at week 2. We used analysis of covariance adjusting and mixed linear effect models to evaluate patient-reported outcomes. We used Fisher exact test to compare patient-reported discussion of EOL care preferences and receipt of chemotherapy in the last 30 days of life. RESULTS: Of 235 eligible patients, 160 (68.1%) were enrolled; of the 160 participants, the median (range) age was 64.4 (19.7-80.1) years, and 64 (40.0%) were women. Compared with those receiving UC, IPC participants reported better QOL (adjusted mean score, 107.59 vs 116.45; P = .04), and lower depression (adjusted mean score, 7.20 vs 5.68; P = .02), anxiety (adjusted mean score, 5.94 vs 4.53; P = .02), and PTSD symptoms (adjusted mean score, 31.69 vs 27.79; P = .01) at week 2. Intervention effects were sustained to week 24 for QOL (β, 2.35; 95% CI, 0.02-4.68; P = .048), depression (β, −0.42; 95% CI, −0.82 to −0.02; P = .04), anxiety (β, −0.38; 95% CI, −0.75 to −0.01; P = .04), and PTSD symptoms (β, −1.43; 95% CI, −2.34 to −0.54; P = .002). Among patients who died, those receiving IPC were more likely than those receiving UC to report discussing EOL care preferences (21 of 28 [75.0%] vs 12 of 30 [40.0%]; P = .01) and less likely to receive chemotherapy near EOL (15 of 43 [34.9%] vs 27 of 41 [65.9%]; P = .01). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of patients with AML, IPC led to substantial improvements in QOL, psychological distress, and EOL care. Palliative care should be considered a new standard of care for patients with AML. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02975869

Supplemental Digital Content is available in the text.Body composition analysis, also referred to as analytic morphomics, morphomics, or morphometry, describes the measurement of imaging biomarkers of body composition such as muscle and adipose tissue, most commonly on computed tomography (CT) images. A growing body of literature supports the use of such metrics derived from routinely acquired CT images for risk prediction in various patient populations, including those with lung cancer. Metrics include cross-sectional area and attenuation of skeletal muscle and subcutaneous, visceral, and intermuscular adipose tissue. The purpose of this review is to provide an overview of the concepts, definitions, assessment tools, segmentation techniques and associated pitfalls, interpretation of those measurements on chest and abdomen CT, and a discussion of reported outcomes associated with body composition metrics in patients with early-stage and advanced lung cancer.

IntroductionPerformance status is an essential consideration for clinical practice and for patient eligibility for clinical trials in oncology. Assessment of performance status is traditionally done by clinicians, but there is an increasing interest in patient-completed assessment. The aim of this systematic review and meta-analysis was to summarise inter-rater concordance between patient and clinician ratings of performance status.MethodsA search strategy was developed and executed in the databases of Ovid MEDLINE, Embase and Cochrane Central Register of Controlled Trials, from inception until 15 August 2019. Articles were eligible for inclusion if there was mention of both (1) use of performance status tool Karnofsky Performance Status (KPS) or Eastern Cooperative Oncology Group Performance Status (ECOG), and (2) assessment of performance status by both clinicians and patients. Pearson correlation coefficients were calculated for each study and were meta-analysed according to a random-effect analysis model. Analyses were conducted using Comprehensive Meta-Analysis (V.3) by Biostat.ResultsSixteen articles were included in our review, reporting on a cumulative sample size of 6619 patients. The quality of evidence was moderate, as determined by the GRADE tool.Concordance ranged from fair to moderate for both the KPS and ECOG tools. The Pearson correlation coefficient was 0.449 for KPS and 0.584 for ECOG.ConclusionsThere is fair to moderate concordance of patient and clinician performance status ratings. Future studies should examine the reasoning behind clinician and patient ratings to better understand discrepancies between ratings.

Sexual dysfunction is the most common complication affecting HSCT survivors and is associated with worse psychological distress and patient QOL. Yet, interventions to address sexual dysfunction in HSCT survivors are lacking.

Sexual dysfunction is the most common complication affecting HCT survivors and is associated with worse patient-reported quality of life (QOL) and psychological distress. Yet, interventions to address sexual dysfunction in HCT survivors are lacking.

Patients undergoing HSCT and their caregivers endure substantial psychological distress during the transplant hospitalization. Prior single-center studies established the feasibility and promising efficacy of integrating palliative care during the HSCT hospitalization. However, data regarding the efficacy of this care model across diverse care settings are lacking.

Older patients with AML face difficult treatment decisions as they can be treated either with ‘intensive’ chemotherapy requiring prolonged hospitalization, or ‘non-intensive’ chemotherapy. Although clinicians often perceive intensive chemotherapy as more burdensome, research is lacking on patients’ quality of life (QOL) and psychological distress. We conducted a longitudinal study of older patients (≥60 years) newly diagnosed with AML receiving intensive (cytarabine/anthracycline combination) or non-intensive (hypomethylating agents) chemotherapy. We assessed patients’ QOL [Functional-Assessment-of-Cancer-Therapy-Leukemia] and psychological distress [Hospital-Anxiety-and-Depression-Scale] at baseline and 2, 4, 8, 12, and 24 weeks after diagnosis. We enrolled 75.2% (100/133) of eligible patients within 72-hours of initiating intensive (n= 50) or non-intensive (n= 50) chemotherapy. Patient QOL improved over time (β= 0.32, P= 0.013). At baseline, 33.3% (33/100) and 30.0% (30/100) of patients reported clinically significant depression and anxiety symptoms, respectively, with no differences between groups. Patients’ depression symptoms did not change over time, while their anxiety symptoms decreased over time (β= −0.08, P< 0.001). Patient-reported QOL, depression and anxiety symptoms did not differ significantly at any time point between those who received intensive versus non-intensive chemotherapy. Older patients with AML experience improvements in their QOL and anxiety while undergoing treatment. Patients receiving intensive and non-intensive chemotherapy have similar QOL and mood trajectories.

Background:Patients with hematologic malignancies experience a substantial decline in their quality of life (QOL) and psychological health during their hospitalization for hematopoietic stem cell transplantation (HSCT). Early single center studies established the feasibility and promising preliminary efficacy of integrating palliative care during the HSCT hospitalization. However, data to test the efficacy of this care model across diverse care settings are lacking.

Background:Sexual dysfunction is the most common complication affecting HCT survivors and is associated with worse patient-reported quality of life (QOL) and psychological distress. Yet, interventions to address sexual dysfunction in HCT survivors are lacking.

Supplemental Digital Content is available in the text