Faith Melissa A, Schimmel-Bristow Allison, Boone Dianna M, Johnston Julia D, Henschen Elizabeth, Beaupin Lynda, Sobalvarro Sarah
Center for Behavioral Health, Johns Hopkins All Children's Hospital, Saint Petersburg, FL, United States.
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
J Pediatr Psychol. 2025 Feb 1;50(2):151-161. doi: 10.1093/jpepsy/jsae082.
Poor nutrition and physical activity pose negative health risks for adolescent and young adult pediatric cancer survivors (AYACS). Our pilot randomized controlled trial (RCT) evaluated feasibility and acceptability of a telehealth intervention (ENHANCE) supporting AYACS' nutrition and physical activity.
We randomized 58 AYACS and their adult care partner, when applicable, to the ENHANCE or control condition. Inclusion required an age of 15-25 years, previous chemotherapy or radiation therapy, and no eating disorder history. We utilized a 2:1 (ENHANCE [n = 35]: control [n = 23]) double-blind block randomization protocol in blocks of 6. ENHANCE comprised 12 (60-min) sessions that included education, skill-building, and values-based healthy lifestyle decision-making. The first five sessions included motivational interviewing and the final seven sessions included problem-solving training/goal setting. We evaluated feasibility based on eligibility, enrollment, attrition, and study completion percentages. We assessed fidelity using the Session Content-Fidelity Rating Tool and the Motivational Interviewing Treatment Integrity Coding form. We assessed acceptability using the Abbreviated Acceptability Rating Profile, the Revised Helping Alliance Questionnaire, and participants' exit interviews.
ENHANCE was feasible and highly acceptable; all but one participant who started the intervention completed all 12 sessions and all participants reported enjoying the intervention via objective assessment and during exit interviews. Interventionists delivered ENHANCE with high fidelity.
ENHANCE was highly acceptable among AYACS and care partners. The telehealth study design was feasible, suggesting benefits and feasibility of a future, larger, multisite RCT. Promising findings support our methodological decisions as important considerations to inform a larger RCT.
营养状况不佳和身体活动不足对青少年及青年期儿科癌症幸存者(AYACS)的健康构成负面风险。我们的初步随机对照试验(RCT)评估了一项支持AYACS营养和身体活动的远程医疗干预措施(ENHANCE)的可行性和可接受性。
我们将58名AYACS及其成年护理伙伴(如适用)随机分为ENHANCE组或对照组。纳入标准要求年龄在15至25岁之间,既往接受过化疗或放疗,且无饮食失调史。我们采用2:1(ENHANCE组[n = 35]:对照组[n = 23])的双盲区组随机化方案,每组6人。ENHANCE包括12节(每节60分钟)课程,内容包括教育、技能培养以及基于价值观的健康生活方式决策。前五节课程包括动机性访谈,后七节课程包括问题解决训练/目标设定。我们根据入选率、入组率、失访率和研究完成率评估可行性。我们使用课程内容保真度评分工具和动机性访谈治疗完整性编码表评估保真度。我们使用简化可接受性评分量表、修订后的帮助联盟问卷以及参与者的退出访谈评估可接受性。
ENHANCE是可行的且高度可接受;开始干预的参与者中除一人外均完成了全部12节课程,所有参与者通过客观评估和退出访谈均表示喜欢该干预措施。干预者高度保真地实施了ENHANCE。
ENHANCE在AYACS及其护理伙伴中高度可接受。远程医疗研究设计是可行的,这表明未来进行更大规模、多中心RCT具有益处和可行性。有前景的研究结果支持我们的方法学决策,这些决策是为更大规模RCT提供信息的重要考虑因素。