A Multimodal Lifestyle Psychosocial Survivorship Program in Young Cancer Survivors
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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. / 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; Hilgendorf, Inken; Koehler, Michael; Puzik, Alexander; Salzmann, Nicole; Sander, Annette; Schiffmann, Lisa; Sokalska-Duhme, Magdalena; Schuster, Sonja; Kock-Schoppenhauer, Ann-Kristin; Bokemeyer, Carsten; Sinn, Marianne; Stein, Alexander; Dwinger, Sarah; Salchow, Jannike.
In: JAMA NETW OPEN, Vol. 7, No. 3, 04.03.2024, p. e242375.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - A Multimodal Lifestyle Psychosocial Survivorship Program in Young Cancer Survivors
T2 - The CARE for CAYA Program-A Randomized Clinical Trial Embedded in a Longitudinal Cohort Study
AU - von Grundherr, Julia
AU - Elmers, Simon
AU - Koch, Barbara
AU - Hail, Lesley-Ann
AU - Mann, Julia
AU - Escherich, Gabriele
AU - Bergelt, Corinna
AU - Samland, Luisa
AU - Jensen, Wiebke
AU - Vettorazzi, Eik
AU - Stark, Maria
AU - Valentini, Luzia
AU - Baumann, Freerk T
AU - Singer, Susanne
AU - Reer, Rüdiger
AU - Beller, Ronja
AU - Calaminus, Gabriele
AU - Faber, Jörg
AU - Classen, Carl Friedrich
AU - Gebauer, Judith
AU - Hilgendorf, Inken
AU - Koehler, Michael
AU - Puzik, Alexander
AU - Salzmann, Nicole
AU - Sander, Annette
AU - Schiffmann, Lisa
AU - Sokalska-Duhme, Magdalena
AU - Schuster, Sonja
AU - Kock-Schoppenhauer, Ann-Kristin
AU - Bokemeyer, Carsten
AU - Sinn, Marianne
AU - Stein, Alexander
AU - Dwinger, Sarah
AU - Salchow, Jannike
PY - 2024/3/4
Y1 - 2024/3/4
N2 - 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.
AB - 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.
KW - Adolescent
KW - Adult
KW - Child
KW - Female
KW - Male
KW - Humans
KW - Longitudinal Studies
KW - Survivorship
KW - Quality of Life
KW - Cancer Survivors
KW - Cohort Studies
KW - Life Style
KW - Fatigue
KW - Neoplasms/therapy
U2 - 10.1001/jamanetworkopen.2024.2375
DO - 10.1001/jamanetworkopen.2024.2375
M3 - SCORING: Journal article
C2 - 38526495
VL - 7
SP - e242375
JO - JAMA NETW OPEN
JF - JAMA NETW OPEN
SN - 2574-3805
IS - 3
ER -
