Department of Oncology, Hematology, BMT with Section Pneumology, Hubertus Wald Tumor Center, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Department of Pediatric Hematology and Oncology, Hubertus Wald Tumor Center, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
JAMA Netw Open. 2024 Mar 4;7(3):e242375. doi: 10.1001/jamanetworkopen.2024.2375.
There is a lack of trials examining the effect of counseling interventions for child, adolescent, and younger adult (CAYA) cancer survivors.
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.
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.
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.
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.
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.
German Clinical Trial Register: DRKS00012504.
缺乏针对儿童、青少年和年轻成人 (CAYA) 癌症幸存者的咨询干预效果的试验。
评估 CAYA 的生活方式习惯和心理社会状况，以确定 CARE for CAYA 计划 (CFC-P) 中基于需求的干预措施的效果。
设计、地点和参与者：CFC-P 作为一项多中心计划在 14 家德国门诊诊所（主要是大学癌症中心）进行。招募于 2018 年 1 月 1 日开始；一项随机临床试验持续到 2019 年 7 月 15 日；干预作为一项纵向队列研究继续进行，直到 2021 年 3 月 31 日。数据准备于 2021 年 4 月 1 日进行，分析于 2021 年 8 月 14 日至 2022 年 5 月 31 日进行。此处，预定的确认性分析与 RCT 有关，描述性结果与整个纵向研究有关。数据分析基于全分析集，该分析集尽可能接近意向治疗原则。
全面评估确定了身体活动、营养和心理肿瘤学方面的需求。有高需求的人参加了 1 到 3 个模块。在 RCT 中，IG 接受了 5 次咨询会议加通讯，而 CG 只接受了 1 次咨询会议。
主要结果是在 52 周时高需求的 CAYA 比例的变化。次要结果是可行性、特定模块的终点、满意度、生活质量和疲劳。
在接触的 1502 名 15 至 39 岁的 CAYA 中，692 人拒绝参与。另外排除了 22 名 CAYA，最终有 788 名参与者。在随机临床试验中，359 名 CAYA 被随机分配（干预组 [IG]，n=183；对照组 [CG]，n=176），274 名 CAYA 进行了随访。在 RCT 中，中位年龄为 25.0（IQR，19.9-32.2）岁；226 名女性（63.0%）和 133 名男性（37.0%）。52 周后，IG 中有 120 名（87.0%）和 CG 中有 115 名（86.5%）CAYA 在至少 1 个模块中仍有高需求（比值比，1.04；95%CI，0.51-2.11；P=0.91）。两组均报告需求减少、生活质量提高、疲劳减轻和对 CFC-P 的高度满意。
在这项随机临床试验中，尽管未达到主要结果，但该队列中实施生活方式计划是必要的。干预措施并未改变高需求的比例。结果可能为 CAYA 后续护理中多模式干预的发展提供指导。
德国临床试验注册处：DRKS00012504。
