Memorial Sloan Kettering Cancer Center, NY, New York, United States of America.
Massachusetts General Hospital Cancer Center, Boston, MA, United States of America.
Contemp Clin Trials. 2022 Nov;122:106923. doi: 10.1016/j.cct.2022.106923. Epub 2022 Sep 14.
Caregivers of patients with cancer play a crucial role in the health of the person they care for, and in the healthcare system at large. Family caregivers receive minimal support, despite being at greater risk for anxiety and depression than patients themselves. Cognitive behavioral therapy (CBT), an effective therapy for anxiety and depression, has shown mixed efficacy when delivered to cancer caregivers. Emotion Regulation Therapy (ERT), a contemporary CBT, may uniquely target processes underlying distress associated with caregiving. Therefore, we adapted both CBT and ERT to target the needs of caregivers (i.e., CBT-C and ERT-C) and are conducting a multi-site randomized trial to examine the comparative efficacy of these interventions.
Family cancer caregivers (n = 200) reporting distress related to caregiving are recruited from two academic cancer centers and randomly assigned to either ERT-C or CBT-C. Caregivers in both interventions engage in eight weekly one-hour sessions by videoconference with a trained interventionist. Caregiver participants complete study assessments at baseline, post-treatment, 3-and 6-months follow-up. Patients of each caregiver can also enroll in the study and complete assessments at baseline and 3-months follow-up. Outcome measures include psychosocial constructs such as anxiety, depression, quality of life, as well as proposed mechanistic constructs and salivary markers of stress and inflammation.
The results of this study will advance the science of caregiving interventions in cancer by addressing a critical gap in our ability to mitigate anxiety and depression in caregivers, as well as further our understanding of how these changes may influence patients' outcomes.
癌症患者的照顾者在患者的健康和整个医疗体系中起着至关重要的作用。尽管家庭照顾者的焦虑和抑郁风险比患者本身更高,但他们得到的支持却很少。认知行为疗法(CBT)是一种治疗焦虑和抑郁的有效方法,但在向癌症照顾者提供时效果不一。情绪调节疗法(ERT)是一种现代的 CBT,可能会针对与照顾相关的困扰的潜在过程进行独特的靶向治疗。因此,我们对 CBT 和 ERT 进行了改编,以满足照顾者的需求(即 CBT-C 和 ERT-C),并正在进行一项多地点随机试验,以检验这些干预措施的比较疗效。
从两个学术癌症中心招募报告与照顾相关的困扰的家庭癌症照顾者(n=200),并随机分配到 ERT-C 或 CBT-C 组。两种干预措施中的照顾者都通过视频会议与经过培训的干预者进行八次每周一小时的疗程。照顾者参与者在基线、治疗后、3 个月和 6 个月随访时完成研究评估。每位照顾者的患者也可以参加研究,并在基线和 3 个月随访时完成评估。结果测量包括焦虑、抑郁、生活质量等心理社会结构,以及拟议的机制结构和压力和炎症的唾液标志物。
这项研究的结果将通过解决我们减轻照顾者焦虑和抑郁的能力方面的一个关键差距,推进癌症照顾者干预措施的科学研究,同时进一步了解这些变化如何影响患者的结果。