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- Title
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.
- Authors
von Grundherr, Julia; Elmers, Simon; Koch, Barbara; Hail, Lesley-Ann; Mann, Julia; Escherich, Gabriele; Bergelt, Corinna; Samland, Luisa; Jensen, Wiebke; Vettorazzi, Eik; Stark, Maria; Valentini, Luzia; Baumann, Freerk T.; Singer, Susanne; Reer, Rüdiger; Beller, Ronja; Calaminus, Gabriele; Faber, Jörg; Classen, Carl Friedrich; Gebauer, Judith
- Abstract
Key Points: Question: Can a multimodal survivorship lifestyle program with counseling interventions physical activity, nutrition, and psychooncology improve the health behaviors and psychosocial situation in children, adolescents, and younger adults (CAYAs) who are cancer survivors? Findings: This randomized clinical trial including 359 CAYAs with a high need for intervention did not show a significant difference between the cohorts who received intervention and the controls. However, both groups reported reduced needs, improved quality of life, reduced fatigue, and high satisfaction with the program. Meaning: The findings of this trial suggest that the needs of CAYAs are complex, and further studies are needed to better understand which specific interventions are effective for this group. 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 This randomized clinical trial followed by a longitudinal study evaluated the use of needs-based interventions including physical activity, nutrition, and psychoongology in children, adolescent, and younger adult cancer survivors.
- Subjects
GERMANY; LIFESTYLES; HUMAN services programs; RESEARCH funding; CANCER; RANDOMIZED controlled trials; DESCRIPTIVE statistics; CHI-squared test; LONGITUDINAL method; ODDS ratio; CANCER patient psychology; NEEDS assessment; DATA analysis software; COUNSELING; PHYSICAL activity; NUTRITION; ADOLESCENCE
- Publication
JAMA Network Open, 2024, Vol 7, Issue 3, pe242375
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2024.2375