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In the KEYNOTE-177 study, pembrolizumab monotherapy provided statistically significant and clinically meaningful improvements in progression-free survival versus chemotherapy as first-line treatment in patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. To further support the efficacy and safety findings of the KEYNOTE-177 study, results of the health-related quality of life (HRQOL) analyses are reported here. KEYNOTE-177 is an open-label, randomised, phase 3 trial being done at 192 cancer centres in 23 countries, in patients aged 18 years and older with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer, with an Eastern Cooperative Oncology Group performance status of 0 or 1, and who had not received previous systemic therapy for metastatic disease. Eligible patients were randomly assigned (1:1) centrally by use of interactive voice response or integrated web response technology to receive pembrolizumab 200 mg intravenously every 3 weeks or investigator's choice chemotherapy (mFOLFOX6 [leucovorin, fluorouracil, and oxaliplatin] or FOLFIRI [leucovorin, fluorouracil, and irinotecan] intravenously every 2 weeks with or without intravenous bevacizumab or cetuximab). Patients and investigators were not masked to treatment assignment. The primary endpoints were progression-free survival (previously reported) and overall survival (data to be reported at the time of the final analysis). HRQOL outcomes were evaluated as prespecified exploratory endpoints. The analysis population comprised all randomly assigned patients who received at least one dose of study treatment and completed at least one HRQOL assessment. HRQOL outcomes were mean change from baseline to prespecified week 18 in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC Quality of Life Questionnaire-Colorectal 29 (EORTC QLQ-CR29) scale and item scores, and in the EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) visual analogue scale and health utility scores; the proportion of patients with improved, stable, or deteriorated scores from baseline to prespecified week 18 in EORTC QLQ-C30 scales and items; and time to deterioration in EORTC QLQ-C30 global health status/quality of life (GHS/QOL), physical functioning, social functioning, and fatigue scores and EORTC QLQ-CR29 urinary incontinence scores. The threshold for a small and clinically meaningful mean difference in EORTC QLQ-C30 score was 5–8 points. This study is registered with ClinicalTrials.gov, NCT02563002 and is ongoing; recruitment is closed. Between Feb 11, 2016, and Feb 19, 2018, 307 patients were enrolled and randomly assigned to receive pembrolizumab (n=153) or chemotherapy (n=154). The HRQOL analysis population comprised 294 patients (152 receiving pembrolizumab and 142 receiving chemotherapy). As of Feb 19, 2020, median time from randomisation to data cutoff was 32·4 months (IQR 27·7–37·8). Least squares mean (LSM) change from baseline to prespecified week 18 showed a clinically meaningful improvement in EORTC QLQ-C30 GHS/QOL scores with pembrolizumab versus chemotherapy (between-group LSM difference 8·96 [95% CI 4·24–13·69]; two-sided nominal p=0·0002). Median time to deterioration was longer with pembrolizumab versus chemotherapy for GHS/QOL (hazard ratio 0·61 [95% CI 0·38–0·98]; one-sided nominal p=0·019), physical functioning (0·50 [95% CI 0·32–0·81]; one-sided nominal p=0·0016), social functioning (0·53 [95% CI 0·32–0·87]; one-sided nominal p=0·0050), and fatigue scores (0·48 [95% CI 0·33–0·69]; one-sided nominal p<0·0001). Pembrolizumab monotherapy led to clinically meaningful improvements in HRQOL compared with chemotherapy in patients with previously untreated microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. These data, along with the previously reported clinical benefits, support pembrolizumab as a first-line treatment option for this population. Merck Sharp & Dohme, a subsidiary of Merck & Co, Kenilworth, NJ, USA.

Physical activity (PA) can improve a range of outcomes following a cancer diagnosis. These include an improvement in experience of side effects of treatment (eg, fatigue) and management of comorbid conditions. PA might also increase survival and reduce recurrence. Digital interventions have shown potential for PA promotion among cancer survivors, but most in a previous review were Web-based, and few studies used mobile apps. There are many PA apps available for general public use, but it is unclear whether these are suitable as a PA intervention after a cancer diagnosis. This study sought posttreatment nonmetastatic breast, prostate, and colorectal cancer survivors' opinions of using smartphone apps to promote PA and gathered their views on existing publicly available PA apps to inform a future intervention. Each participant was randomly assigned to download 2 of 4 apps (Human, The Walk, The Johnson & Johnson Official 7 Minute Workout, and Gorilla Workout). Participants used each app for 1 week consecutively. In-depth semistructured telephone interviews were then conducted to understand participants' experiences of using the apps and how app-based PA interventions could be developed for cancer survivors. The interviews were analyzed using thematic analysis. Thirty-two participants took part: 50% (16/32) had prostate cancer, 25% (8/32) had breast cancer, and 25% (8/32) had colorectal cancer. Three core themes were identified. The first theme was that multiple factors affect engagement with PA apps and this is highly personalized. Factors affecting engagement included participants' perceptions of (1) the advantages and disadvantages of using apps to support PA, (2) the relevance of the app to the user (eg, in terms of cancer-related factors, their PA goals, the difficulty level of the app, the way in which they interact with their mobile phone, and the extent to which the app fits with their self-identity), (3) the quality of the app (eg, usability, accuracy, quality of production, and scientific evidence-base), and (4) the behavior change techniques used to promote PA. In the second theme, participants recommended that apps that promote walking are most appealing, as walking removes many barriers to PA. Finally, the participants suggested that PA apps should be integrated into cancer care, as they valued guidance and recommendations from health care professionals. This sample of breast, prostate, and colorectal cancer survivors was receptive to the use of apps to promote PA. Although no publicly available PA app was deemed wholly suitable, many suggestions for adaptation and intervention development were provided. The results can inform the development of an app-based PA intervention for cancer survivors. They also highlight the wide-ranging and dynamic influences on engagement with digital interventions, which can be applied to other evaluations of mobile health products in other health conditions and other health behaviors.

Background Over 1.3 million people live with colorectal cancer in the United States. Physical activity is associated with lower risk of colorectal cancer recurrence and mortality. Interventions are needed to increase physical activity in colorectal cancer survivors. Methods We conducted a 2-arm non-blinded pilot randomized controlled trial at the University of California, San Francisco among 42 individuals who had completed curative-intent treatment for colorectal cancer to determine the feasibility and acceptability of a 12-week (84 days) physical activity intervention using a Fitbit Flex™ and daily text messages. Participants were randomized 1:1 to receive the intervention with print educational materials or print educational materials alone. We explored the impact of the intervention versus usual care on physical activity using ActiGraph GT3X+ accelerometers pre−/post-intervention. Results We screened 406 individuals and randomized 42 to intervention ( n  = 21) or control ( n  = 21) groups. During the 12-week study, the intervention arm wore their Fitbits a median of 74 days [88% of days in study period, interquartile range: 23–83 days] and responded to a median of 34 (out of 46) text messages that asked for a reply (interquartile range: 13–38 text messages). Among the 16 intervention participants who completed the feedback survey, the majority (88%) reported that the intervention motivated them to exercise and that they were satisfied with their experience. No statistically significant difference in change in moderate-to-vigorous physical activity was found from baseline to 12 weeks between arms. Conclusion A 12-week physical activity intervention with a Fitbit and text messages was feasible and acceptable among colorectal cancer patients after curative treatment. Larger studies are needed to determine whether the intervention increases physical activity. Trial registration Clinicaltrials.gov Identifier NCT02966054 . Registered 17 November 2016, retrospectively registered.

PurposeTo assess the effects of dietary and physical activity (PA) interventions on generic and cancer-specific quality of life (QoL), anxiety, and depression levels among adult Chinese colorectal cancer (CRC) survivors.MethodsTwo-hundred twenty-three adult CRC survivors within 1 year of completion of primary cancer treatment were randomized to receive dietary, PA or combined intervention, or usual care for a 12 monthduration, under a 2 (diet vs usual care) × 2 (PA vs usual care) factorial design. Generic and cancer-specific QoL was assessed using a Chinese version 12-Item Short Form Health Survey (SF-12) and the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) scale, respectively. Anxiety and depression was assessed using the Hospital Anxiety and Depression Scale at baseline, 6, 12, 18, and 24 months. Linear mixed models were used for examining the intervention effects.ResultsParticipants receiving dietary intervention experienced a significant improvement in the generic measure of QoL (SF-6D utility scores, mean difference 0.042, 95%CI 0.03 to 0.081) at 12 months, the cancer-specific QoL scores (mean difference 3.09, 95%CI 0.13 to 6.04), and levels of depression (P = 0.015) at both 12 and 24 months follow-up. Participants receiving PA intervention only demonstrated a significant improvement in SF-6D utility index (mean difference 0.039, 95%CI 0.002 to 0.077) and physical functioning (mean difference 2.85, 95%CI 1.00 to 4.70) at 6 months.ConclusionsDietary intervention improved the generic and cancer-specific QoL and depression in CRC survivors.Trial registrationThe study was prospectively registered on 17 October 2012 at ClinicalTrials.gov (NCT01708824).Implications for Cancer SurvivorsCRC survivors can benefit from dietary interventions in alleviating depression and improving overall health-related QoL.

Purpose Cancer-related cognitive impairment (CRCI) is a common, fatigue-related symptom that disrupts cancer survivors’ quality of life. Few interventions for CRCI exist. As part of a randomized pilot study targeting cancer-related fatigue, the effects of mindfulness-based stress reduction (MBSR) on survivors’ cognitive outcomes were investigated. Methods Breast and colorectal cancer survivors ( n  = 71) with moderate-to-severe fatigue were randomized to MBSR ( n  = 35) or a fatigue education and support (ES; n  = 36) condition. The Attentional Function Index (AFI) and the Stroop test were used to assess survivors’ cognitive function at baseline (T1), after the 8-week intervention period (T2), and 6 months later (T3) using intent-to-treat analysis. Mediation analyses were performed to explore mechanisms of intervention effects on cognitive functioning. Results MBSR participants reported significantly greater improvement on the AFI total score compared to ES participants at T2 ( d  = 0.83, p  = 0.001) and T3 ( d  = 0.55, p  = 0.021). MBSR also significantly outperformed ES on most AFI subscales, although both groups improved over time. MBSR produced greater Stroop accuracy rates relative to ES at T2 ( r  = 0.340, p  = 0.005) and T3 ( r  = 0.280, p  = 0.030), with improved accuracy over time only for the MBSR group. There were no significant differences in Stroop reaction time between groups. Improvements in mindfulness mediated the effect of group (e.g., MBSR vs. ES) on AFI total score at T2 and T3. Conclusions Additional randomized trials with more comprehensive cognitive measures are warranted to definitively assess the efficacy of MBSR for CRCI. Implications for Cancer Survivors This pilot study has important implications for all cancer survivors as it is the first published trial to show that MBSR offers robust and durable improvements in CRCI.

Background Multiple health behavior change can ameliorate adverse effects of cancer. Purpose The purpose of this study was to determine the effects of a multiple health behavior change intervention (CanChange) for colorectal cancer survivors on psychosocial outcomes and quality of life. Methods A total of 410 colorectal cancer survivors were randomized to a 6-month telephone-based health coaching intervention (11 sessions using acceptance and commitment therapy strategies focusing on physical activity, weight management, diet, alcohol, and smoking) or usual care. Posttraumatic growth, spirituality, acceptance, mindfulness, distress, and quality of life were assessed at baseline, 6 and 12 months. Results Significant intervention effects were observed for posttraumatic growth at 6 (7.5, p  < 0.001) and 12 months (4.1, p  = 0.033), spirituality at 6 months (1.8, p  = 0.011), acceptance at 6 months (0.2, p  = 0.005), and quality of life at 6 (0.8, p  = 0.049) and 12 months (0.9, p  = 0.037). Conclusions The intervention improved psychosocial outcomes and quality of life (physical well-being) at 6 months with most effects still present at 12 months. (Trial Registration Number: ACTRN12608000399392).

The APPROACH pilot study explored the feasibility and acceptability of an app (NHS Active 10) with brief, habit-based, behavioral support calls and print materials intended to increase brisk walking in people diagnosed with cancer. Following UK Medical Research Council guidelines, this study assessed the implementation of the intervention, examined the mechanisms of impact, and identified contextual factors influencing engagement. Adults (aged ≥18 y) with breast, prostate, or colorectal cancer who reported not meeting the UK guidelines for moderate-to-vigorous physical activity (≥150 min/wk) were recruited from a single hospital site in Yorkshire, United Kingdom. They were randomly assigned to the intervention or control (usual care) arm and assessed via quantitative surveys at baseline (time point 0 [T0]) and 3-month follow-up (time point 1 [T1]) and qualitative exit interviews (36/44, 82%) at T1. The process evaluation included intervention participants only (n=44). Implementation was assessed using data from the T1 questionnaire exploring the use of the intervention components. The perceived usefulness of the app, leaflet, and behavioral support call was rated from 0 to 5. Behavioral support calls were recorded, and the fidelity of delivery of 25 planned behavior change techniques was rated from 0 to 5 using an adapted Dreyfus scale. Mechanisms of impact were identified by examining T0 and T1 scores on the Self-Reported Behavioural Automaticity Index and feedback on the leaflet, app, call, and planner in the T1 questionnaire and qualitative interviews. Contextual factors influencing engagement were identified through qualitative interviews. The implementation of the intervention was successful: 98% (43/44) of the participants received a behavioral support call, 78% (32/41) reported reading the leaflet, 95% (39/41) reported downloading the app, and 83% (34/41) reported using the planners. The mean perceived usefulness of the app was 4.3 (SD 0.8) in participants still using the app at T1 (n=33). Participants rated the leaflet (mean 3.9, SD 0.6) and the behavioral support call (mean 4.1, SD 1) as useful. The intended behavior change techniques in the behavioral support calls were proficiently delivered (overall mean 4.2, SD 1.2). Mechanisms of impact included habit formation, behavioral monitoring, and support and reassurance from the intervention facilitator. Contextual factors impacting engagement included barriers, such as the impact of cancer and its treatment, and facilitators, such as social support. The APPROACH intervention was successfully implemented and shows promise for increasing brisk walking, potentially through promoting habit formation and enabling self-monitoring. Contextual factors will be important to consider when interpreting outcomes in the larger APPROACH randomized controlled trial. RR2-10.1186/s40814-022-01028-w.

BackgroundColorectal cancer screening by fecal immunochemical test (FIT) reduces the burden of colorectal cancer. However, effectiveness relies on annual adherence, which presents challenges for clinic staff and patients.ObjectiveDescribe FIT return rates and identify factors associated with FIT adherence over 2 years in a mailed FIT outreach program in federally qualified health centers.DesignObservational study nested in the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) trial. Five thousand one hundred ninety-five patients had an initial FIT order and were followed for ≥ 2 years (3574 also had a FIT order in the second year).Main MeasuresFIT return percent in each year and patient- and neighborhood-level characteristics associated with FIT adherence.Key ResultsOverall, the proportion of FIT orders that were completed was 46% in the patients’ first year and 41% in the patients’ second year. Of the 5195 patients with a FIT order in year 1, 3574 (69%) also had a FIT order in year 2 (71% of year 1 adherers and 67% of year 1 non-adherers, p = 0.009). Among those with a FIT order in the second year, the FIT return rate was about twice as high among those who were adherent in the first year (952/1674, or 57%) as among those who were not (531/1900, or 28%, p < 0.0001). Patient-level characteristics associated with higher odds of FIT return were a history of FIT screening at baseline, age over 65 (vs 50–65), no current tobacco use, recent receipt of a mammogram or flu vaccine, Asian ancestry (compared to non-Hispanic white), and non-English preference. The only neighborhood factor associated with lower FIT return rate was patient’s larger residential city size.ConclusionOur findings can inform the customization of programs to promote FIT return among patients who receive care at federally qualified health centers.Trial Registrationhttp://www.clinicaltrials.gov

This study enumerated patients’ preference-based personal utility and willingness-to-pay for massively parallel sequencing (MPS) genetic testing of colorectal cancer (CRC) risk. Our setting was the New Exome Technology in (NEXT) Medicine Study, a randomized control trial of usual care genetic testing vs. exome sequencing. Using a discrete choice experiment (DCE), we elicited patient preferences for information on genetic causes of CRC. We estimated personal utility for the following four attributes: proportion of individuals with a genetic cause of CRC who receive a diagnosis, number of tests used, wait time for results, and cost. A total of 122 patients completed our DCE (66% response rate). On average, patients preferred genetic tests identifying more individuals with a diagnosis and involving a shorter wait time. Assuming MPS identifies more individuals with a Mendelian form of CRC risk, involves fewer tests, and results in a shorter wait than traditional diagnostic testing, average willingness-to-pay (WTP) for MPS ranged from US$400 (95% CI: $300, $500) to US$1541 (95% CI: $1224, $1859). These results indicate that patients value information on genetic causes of CRC and replacing traditional diagnostic testing with MPS testing will increase patients’ utility. Future research exploring the costs and benefits of MPS for CRC risk is warranted.

BackgroundColorectal cancer (CRC) patients frequently experience sleep disturbances, significantly impacting their quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is considered the first-line treatment but is often complex, costly, and requires highly trained therapists. Behavioral activation (BA), derived from cognitive behavioral therapy (CBT), offers a flexible, simple, and cost-effective alternative. BA highlights the importance of activation, a strategy that encourages active participation in positive, meaningful activities to boost positive experiences and reduce negative emotions, which may have potential benefits for individuals with sleep disorders. This study explores the effects of BA on sleep disturbances, quality of life, and psychological distress in CRC patients and investigates potential underlying mechanisms.MethodsThe study included 101 CRC patients with sleep disturbances, who were randomly assigned to either the BA group (n = 53) or the usual care (UC) group (n = 48). Assessments of quality of life, sleep disturbances, psychological distress, activation, avoidance, and physical activity levels were conducted at baseline (T0), four weeks later (T1), and post-intervention (T2). Generalized estimating equation (GEE) analysis was used to evaluate the intervention’s impact and potential mediating effects.ResultsThe BA group experienced significant improvements in sleep disturbances (Wald's χ2 = 7.979, P = 0.019), enhanced quality of life (Wald's χ2 = 6.435.P = 0.04), and reduced psychological distress (Wald's χ2 = 56.728, P < 0.001) compared to the UC group. Physical activity (P < 0.001) partially mediated the intervention effects of BA on sleep disturbances, while activation (P = 0.073) demonstrated marginal mediating effects.ConclusionBA is an effective psychological intervention that significantly improves sleep disturbances, enhances quality of life, and alleviates psychological distress in CRC patients. Mediator analysis indicates that physical activity partially mediates the effects of BA on sleep disturbances, with activation showing marginal significance. Future research should further investigate the underlying mechanisms and long-term effects of BA on sleep disturbances.