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Randomized Controlled Trial
. 2024 Mar 4;7(3):e242375.
doi: 10.1001/jamanetworkopen.2024.2375.

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

Julia von Grundherr  1 , Simon Elmers  1   2 , Barbara Koch  1 , Lesley-Ann Hail  1   2 , Julia Mann  1 , Gabriele Escherich  2 , Corinna Bergelt  3   4 , Luisa Samland  1 , Wiebke Jensen  1 , Eik Vettorazzi  5 , Maria Stark  5 , Luzia Valentini  6 , Freerk T Baumann  7 , Susanne Singer  8 , Rüdiger Reer  9 , Ronja Beller  10 , Gabriele Calaminus  11 , Jörg Faber  12 , Carl Friedrich Classen  13 , Judith Gebauer  14 , Inken Hilgendorf  15 , Michael Koehler  16   17 , Alexander Puzik  18 , Nicole Salzmann  19 , Annette Sander  20 , Lisa Schiffmann  21 , Magdalena Sokalska-Duhme  22 , Sonja Schuster  23 , Ann-Kristin Kock-Schoppenhauer  24 , Carsten Bokemeyer  1 , Marianne Sinn  1 , Alexander Stein  1 , Sarah Dwinger  3 , Jannike Salchow  1
Affiliations
Randomized Controlled Trial

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

Julia von Grundherr et al. JAMA Netw Open. .

Abstract

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Ms von Grundherr reported receiving institutional grants from the Joint Federal Committee (G-BA) during the conduct of the study. Mr Elmers reported receiving institutional grants from the G-BA during the conduct of the study. Ms Hail reported receiving grants from the G-BA during the conduct of the study. Dr Bergelt reported receiving grants from Kindness for Kids Foundation during the conduct of the study. Ms Samland reported receiving institutional grants from the GBA during the conduct of the study. Dr Jensen reported receiving institutional grants from the G-BA during the conduct of the study. Mr Vettorazzi reported receiving grants from the G-BA during the conduct of the study and grants from Deutsche Krebshilfe outside the submitted work. Ms Stark reported receiving grants from the GB-A during the conduct of the study. Dr Faber reported receiving grants from the GB-A Innovations fund during the conduct of the study. Dr Hilgendorf reported receiving grants from the GB-A during the conduct of the study; honoraria from Novartis GmbH, Medac GmbH, Abbvie GmbH, and Takeda GmbH honoraria; travel reimbursement from Medac GmbH, Amgen GmbH, Fondazione Internationale Menarini, BeiGene travel reimbursement, and Janssen-Cilag GmbH outside the submitted work; and is chairperson of the board of trustees of the German Foundation for Young Adults with Cancer. Dr Salzmann reported institutional grants from the G-BA during the conduct of the study. Dr Schiffmann reported receiving institutional grants from the GBA during the conduct of the study. Dr Bokemeyer reported receiving institutional grants from the GB-A during the conduct of the study; speaking fees from AOK Germany; advisory board fees from AstraZeneca, Bayer Healthcare, BioNTech, and Bristol Myers Squibb; speaking and advisory board fees from Jansen Cilag Merck Serono, Roche Pharma, and Sanofi Aventis; advisory board, speaking fees, and nonfinancial support from DGHO, Hamburg Cancer Society, National Network of German Cancer Centers Northern German Society of Internal Medicine outside the submitted work; and nonfinancial support for clinical trials sponsored by industry and cooperative groups. Dr Sinn reported receiving grants from the G-BA during the conduct of the study; personal fees from Roche, Falk, Esanum, AstraZeneca, BMS, Incyte, Servier, Pierre Fabre, MSD, and the G-BA outside the submitted work. Dr Stein reported receiving institutional grants from the GBA during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Participant Flowchart
Randomized clinical trial (RCT) conducted from to January 1, 2018, to July 15, 2019; longitudinal cohort study conducted from July 16, 2019, to March 31, 2021. aAdapted inclusion criteria, no control group, according to the trial protocol (Supplement 1); results presented elsewhere.
Figure 2.
Figure 2.. Development of the High Need Cohorts in the Randomized Clinical Trial
Data for analysis shown for the intervention (A) and control (B) groups. LTFU indicates lost to follow-up; NU, nutrition; PA, physical activity; and PO, psychooncology.
Figure 3.
Figure 3.. Satisfaction With the CARE for CAYA Program
Percentage frequency of each response option for participants' satisfaction with the program in the overall and randomized clinical trial (RCT), longitudinal study, intervention, and control cohorts. CAYA indicates children, adolescents, and younger adults.
See this image and copyright information in PMC

References

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