A Multimodal Lifestyle Psychosocial Survivorship Program in Young Cancer Survivors: The CARE for CAYA Program-A Randomized Clinical Trial Embedded in a Longitudinal Cohort Study.

Importance: There is a lack of trials examining the effect of counseling interventions for child, adolescent, and younger adult (CAYA) cancer survivors. Objective: To assess lifestyle habits and the psychosocial situation of CAYAs to determine the efficacy of needs-based interventions in the CARE for CAYA program (CFC-P). Design, Setting, and Participants: The CFC-P was conducted as a multicenter program in 14 German outpatient clinics, mainly university cancer centers. Recruitment began January 1, 2018; a randomized clinical trial was conducted until July 15, 2019; and intervention was continued as a longitudinal cohort study until March 31, 2021. Data preparation was conducted from April 1, 2021, and analysis was conducted from August 14, 2021, to May 31, 2022. Herein, predefined confirmatory analyses pertain to the RCT and descriptive results relate to the overall longitudinal study. Data analysis was based on the full analysis set, which is as close as possible to the intention-to-treat principle. Intervention: A comprehensive assessment determined needs in physical activity, nutrition and psychooncology. Those with high needs participated in 1 to 3 modules. In the RCT, the IG received 5 counseling sessions plus newsletters, while the control group CG received 1 counseling session. Main Outcomes and Measures: The primary outcome was the change in the rate of CAYAs with high needs at 52 weeks. Secondary outcomes were feasibility, modular-specific end points, satisfaction, quality of life, and fatigue. Results: Of 1502 approached CAYAs aged 15 to 39 years, 692 declined participation. Another 22 CAYAs were excluded, resulting in 788 participants. In the randomized clinical trial, 359 CAYAs were randomized (intervention group [IG], n = 183; control group [CG], n = 176), and 274 were followed up. In the RCT, the median age was 25.0 (IQR, 19.9-32.2) years; 226 were female (63.0%) and 133 male (37.0%). After 52 weeks, 120 CAYAs (87.0%) in the IG and 115 (86.5%) in the CG still had a high need in at least 1 module (odds ratio, 1.04; 95% CI, 0.51-2.11; P = .91). Both groups reported reduced needs, improved quality of life, reduced fatigue, and high satisfaction with the CFC-P. Conclusions and Relevance: In this randomized clinical trial, the implementation of a lifestyle program in this cohort was deemed necessary, despite not meeting the primary outcome. The interventions did not alter the rate of high needs. The results may provide guidance for the development of multimodal interventions in the follow-up care of CAYAs. Trial Registration: German Clinical Trial Register: DRKS00012504.

Effects of Exercise Training on Patient-Specific Outcomes in Pancreatic Cancer Patients: A Scoping Review.

BACKGROUND: International guidelines have already highlighted the beneficial effects of exercise in common cancer entities. However, specific recommendations for pancreatic cancer are still missing. This scoping review aimed to evaluate the impact of exercise training on patient-specific outcomes in pancreatic cancer patients. METHODS: A literature search was undertaken using PubMed, Web of Science, and Cochrane Library. We included randomized controlled trials (RCTs) published before August 2023 with structured exercise interventions during or after pancreatic cancer treatment. RESULTS: Seven articles that prescribed home-based or supervised exercise with aerobic or resistance training or both were reviewed. The results indicate that exercise is feasible and safe in pancreatic cancer patients. Furthermore, exercise was associated with improved quality of life, cancer-related fatigue, and muscle strength. Concerning other outcomes, heterogeneous results were reported. We identified a lack of evidence, particularly for patients with advanced pancreatic cancer. CONCLUSION: Exercise interventions in pancreatic cancer patients are feasible and can lead to improved quality of life, cancer-related fatigue, and muscle strength. However, further studies with larger sample sizes are needed to clarify the potential of exercise in pancreatic cancer, in particular for advanced stages.

A Randomized, Controlled Pilot Study to Evaluate the Immediate Effect of Targeted Exercise Therapy on Cancer-Related Fatigue in Cancer Survivors: The FatiGO Study.

OBJECTIVES: Cancer-related fatigue (CRF) is a clinically relevant side effect that impairs cancer survivors after treatment cessation. Exercise interventions have proven effective; however, specific exercise modalities remain untested. The purpose of this study was to evaluate the feasibility of daily fatigue screenings and to show the impact of various exercise interventions on CRF. METHODS: The randomized controlled pilot study ran for 4 weeks with 3 training sessions per week, in 5 groups: endurance versus strength (moderate- and vigorous-intensity levels for each) compared to a non-active control group. The primary outcome was feasibility; more specifically, it was evaluated whether the documentation with the Numerical Rating Scale (NRS) on a daily basis and the Multidimensional Fatigue Inventory (MFI) on a weekly basis are usable assessments to generate information about CRF. RESULTS: Over the course of the 4-week intervention, 8.3% of the participants (n = 3) dropped out. Thirty-three of the initial 36 participants completed the exercise sessions with an adherence of 95%. Measurements of daily fatigue were collected three times per day, 85% of which were completely filled out. In regard to weekly fatigue, all but one of the questionnaires were submitted (99.5%). Neither during the intervention nor during the tests did any serious adverse events occur within the FatiGO study; hence, the exercise intervention is considered to be feasible for participants. CONCLUSIONS: This pilot study showed the feasibility of close-meshed daily fatigue screening. Preliminary data indicate that cancer survivors are able to train in high-intensity ranges with tendencies toward decreased fatigue. Therefore, practicability of the study design is shown. Further results are expected within the prospective multicenter trial.

A Randomized Controlled Pilot Trial About the Influence of Kyusho Jitsu Exercise on Self-efficacy, Fear, Depression, and Distress of Breast Cancer Patients within Follow-up Care.

INTRODUCTION: Breast cancer survivors are faced with several psychological issues. We report the influence on self-efficacy by a holistic orientated training schedule based on the "Kyusho Jitsu" martial art and explore the effects on self-efficacy, distress, fear, and depression. METHODS: Breast cancer survivors (N = 51) were randomly assigned to an intervention (n = 30) or control group (n = 21). The intervention group participated in a Kyusho Jitsu intervention twice a week over a period of 6 months, the control group received no intervention. Patients from both groups were measured at baseline, 3 and 6 months on level of self-efficacy (German General-Self-Efficacy Scale, SWE), stress (Perceived Stress Questionnaire, PSQ20), and fear and depression (Hospital Anxiety and Depression Scale, HADS). RESULTS: Analysis of the original data showed a significant difference between both groups regarding the subscale "joy" (P = .018). Several significant results within the intervention group were seen in self-efficacy (P = .014), fear (P = .009) and the overall score for fear and depression (P = .043). Both groups improved significantly within "worries" (intervention P = .006, control P = .019) and the PSQ20 overall score (both P = .005). The control group also significantly improved in the subscale for "demands" (P = .019). CONCLUSION: To summarize, our pilot study showed that Kyusho Jitsu training is safe and feasible. Though, the intervention alone cannot be considered as being effective enough to help breast cancer survivors regarding relevant psychological issues, but might be an important supplement offer within follow-up care.

Effects of a structured counselling-based intervention to improve physical activity behaviour of adolescents and young adult cancer survivors - the randomized phase II Motivate AYA - MAYA trial.

OBJECTIVE: To explore whether a structured counselling-based intervention increases vigorous physical activity behaviour of adolescent and young adult cancer survivors. DESIGN: Randomized controlled phase II trial. SETTING: University Cancer Center Hamburg, Germany. SUBJECTS: Eighty-nine participants (mean age 24.1 ± 6.3) were randomized to control (n = 44) or intervention group (n = 45). INTERVENTIONS: The intervention group was consulted about physical activity behaviour via interview (week 0), and telephone counselling (weeks 1, 3 and 12). The control group only received general physical activity guidelines for cancer survivors (week 0). MAIN MEASURES: The primary outcome was the rate of participants with ⩾9 metabolic equivalent (MET)-hours per week of vigorous activity post-intervention, measured with the International Physical Activity Questionnaire. Secondary outcomes included assessing physical activity behaviour (e.g. amount and type of physical activity) and quality of life. Assessments were completed in weeks 0 (baseline), 12 (post-intervention) and 52 (follow-up). RESULTS: Sixty-nine participants completed the post-intervention- and 47 the follow-up-assessment. The rate of participants performing vigorous physical activity increased from baseline to post-intervention for both without differing significantly (P = 0.541). Both increased their total metabolic equivalent from baseline to post-intervention (intervention group from 55.2 ± 43.7 to 61.7 ± 29.4, control group from 75.3 ± 81.4 to 88.3 ± 80.2). At follow-up the intervention group (73.7 ± 80.2) was more active than baseline when compared to the control group (78.5 ± 50.0). CONCLUSIONS: A structured counselling-based physical activity intervention did not significantly impact the level of vigorous physical activity behaviour in adolescent and young adult cancer survivors.

Impact of taste and smell training on taste disorders during chemotherapy - TASTE trial.

PURPOSE: Two-thirds of cancer patients report taste disorders during and after chemotherapy. Taste disorders impact on nutritional status which is highly relevant for treatment efficacy and overall prognosis. Improvement of taste disorder is of particular importance for cancer patients' outcomes, thus the TASTE trial was conducted to improve taste disorders with a taste and smell training. METHODS: In this trial, patients undergoing chemotherapy were screened for taste disorders. Subsequently, patients were allocated based on the detection of taste disorders (≤8 taste strips points) to an intervention group with a taste and smell training at baseline and week 3-5 or were only followed up, if no taste disorder was detected (≥9 taste strips points) (non-intervention group). At baseline, all patients received a nutritional counseling. The primary endpoint was the minimal clinically relevant improvement of taste strips score by 2 taste strips points in at least 50% of the patients with taste disorders. RESULTS: The trial included 62 patients (48 women [77%], 14 male [23%], age 54.5±11.6 years) who had gastrointestinal (n=29), breast (n=31), or lung cancer (n=2). Taste disorders were more frequent in gastrointestinal than in breast cancer patients. Out of 62 patients screened, 30 patients showed taste disorders. The primary endpoint was met with 92% (n=23 of 25) of the patients completing the intervention. In the intervention group, the patients' taste significantly improved from baseline (median taste strips: 7.0 points) to week 12 (median taste strips: 10.0 points) (P≤0.001). Patients of the non-intervention group who completed the reassessment (n=27 of 32) experienced no change in taste perception in the 3-month follow-up (P=0.897). CONCLUSION: Intensified nutritional counseling with taste and smell training may improve taste perception of patients undergoing chemotherapy. A confirmatory randomized trial is planned.