Hyland Kelly A, Amaden Grace H, Diachina Allison K, Miller Shannon N, Dorfman Caroline S, Berchuck Samuel I, Winger Joseph G, Somers Tamara J, Keefe Francis J, Uronis Hope E, Kelleher Sarah A
Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.
Department of Statistical Science, Duke University, Durham, NC, USA.
Contemp Clin Trials Commun. 2023 Apr 5;33:101126. doi: 10.1016/j.conctc.2023.101126. eCollection 2023 Jun.
Colorectal cancer (CRC) patients in early to mid-adulthood (≤50 years) are challenged by high symptom burden (i.e., pain, fatigue, distress) and age-related stressors (e.g., managing family, work). Cognitive behavioral theory (CBT)-based coping skills training interventions reduce symptoms and improve quality of life in cancer patients. However, traditional CBT-based interventions are not accessible to these patients (e.g., in-person sessions, during work day), nor designed to address symptoms within the context of this stage of life. We developed a mobile health (mHealth) coping skills training program for pain, fatigue and distress (mCOPE) for CRC patients in early to mid-adulthood. We utilize a randomized controlled trial to test the extent to which mCOPE reduces pain, fatigue and distress (multiple primary outcomes) and improves quality of life and symptom self-efficacy (secondary outcomes).
METHODS/DESIGN: Patients (N = 160) ≤50 years with CRC endorsing pain, fatigue and/or distress are randomized 1:1 to mCOPE or standard care. mCOPE is a five-session CBT-based coping skills training program (e.g., relaxation, activity pacing, cognitive restructuring) that was adapted for CRC patients in early to mid-adulthood. mCOPE utilizes mHealth technology (e.g., videoconference, mobile app) to deliver coping skills training, capture symptom and skills use data, and provide personalized support and feedback. Self-report assessments are completed at baseline, post-treatment (5-8 weeks post-baseline; primary endpoint), and 3- and 6-months later.
mCOPE is innovative and potentially impactful for CRC patients in early to mid-adulthood. Hypothesis confirmation would demonstrate initial efficacy of a mHealth cognitive behavioral intervention to reduce symptom burden in younger CRC patients.
处于成年早期至中期（≤50岁）的结直肠癌（CRC）患者面临着较高的症状负担（如疼痛、疲劳、痛苦）以及与年龄相关的压力源（如管理家庭、工作）。基于认知行为理论（CBT）的应对技能训练干预可减轻癌症患者的症状并改善生活质量。然而，这些患者无法获得传统的基于CBT的干预措施（如面对面咨询，在工作日期间），而且这些干预措施也未设计用于解决这一生命阶段背景下的症状问题。我们为成年早期至中期的CRC患者开发了一种针对疼痛、疲劳和痛苦的移动健康（mHealth）应对技能训练项目（mCOPE）。我们采用随机对照试验来检验mCOPE在多大程度上减轻疼痛、疲劳和痛苦（多个主要结局）以及改善生活质量和症状自我效能感（次要结局）。
方法/设计：年龄≤50岁且认可存在疼痛、疲劳和/或痛苦症状的CRC患者按1:1随机分为mCOPE组或标准治疗组。mCOPE是一个基于CBT的五节应对技能训练项目（如放松、活动节奏调整、认知重构），该项目针对成年早期至中期的CRC患者进行了调整。mCOPE利用移动健康技术（如视频会议、移动应用程序）来提供应对技能训练、收集症状和技能使用数据，并提供个性化支持和反馈。在基线、治疗后（基线后5 - 8周；主要终点）以及3个月和6个月后完成自我报告评估。
mCOPE具有创新性且可能对成年早期至中期的CRC患者产生影响。假设得到证实将证明一种移动健康认知行为干预措施在减轻年轻CRC患者症状负担方面的初步疗效。
