Kim Youngmee, Tsai Thomas C, Steel Jennifer L, Ramos Alberto R, Laurenceau Jean-Philippe, Troxel Wendy M
Department of Psychology, University of Miami, Coral Gables, FL, USA.
University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Pilot Feasibility Stud. 2025 Jun 14;11(1):82. doi: 10.1186/s40814-025-01671-z.
Sleep disturbance is common and problematic among both patients with cancer and their bedpartner caregivers. Although one's sleep affects the partner's sleep, existing cognitive-behavioral interventions have rarely targeted sleep problems of patients and caregivers simultaneously.
This protocol is to test the feasibility and acceptability of two brief dyadic sleep interventions [My Sleep Our Sleep (MSOS) and Brief Behavioral Treatment for Insomnia for Couples with Cancer (BBTI-CC)] that are designed to reduce sleep disturbance and improve health-related quality of life in adults with cancer and their bedpartner caregivers. Participants (patient-caregiver dyads) will be randomly assigned to either intervention condition. Both interventions will be delivered weekly for 4 weeks. Questionnaire, daily sleep logs, and objectively assessed sleep data will be collected before the intervention (T1), 1-week (T2) and 8-week (T3) after conclusion of the intervention. Participant-reported satisfaction with the intervention will be assessed at the end of each of the four intervention sessions.
We estimate 50 dyads will be enrolled (50 patients and 50 caregivers; 25 dyads in each intervention condition). In both conditions, we expect > 75% of eligible and screened dyads will consent to participate within the enrollment period, > 80% of enrolled dyads will complete the intervention, and > 80% of participants will report satisfaction across all acceptability measures. Additionally, we will explore if both MSOS and BBTI-CC reveal a similar effect on overall sleep disturbance, insomnia severity, and health-related quality of life. Results will inform the feasibility and acceptability of conducting brief dyadic sleep interventions and provide preliminary data to guide further refinement of intervention content and procedure for adult patients with cancer and their bedpartner caregivers in a full trial.
NCT06569693 Clinicaltrials.gov, registered August 22 2024, https://register.
gov/prs/app/action/SelectProtocol?sid=S000ESX9&selectaction=Edit&uid=U0005GPT&ts=2&cx=nb0aq5 .
睡眠障碍在癌症患者及其床伴照顾者中都很常见且成问题。尽管一个人的睡眠会影响伴侣的睡眠，但现有的认知行为干预很少同时针对患者和照顾者的睡眠问题。
本方案旨在测试两种简短的二元睡眠干预措施[我的睡眠我们的睡眠（MSOS）和癌症夫妇失眠简短行为治疗（BBTI-CC）]的可行性和可接受性，这些措施旨在减少癌症成人患者及其床伴照顾者的睡眠障碍并改善与健康相关的生活质量。参与者（患者-照顾者二元组）将被随机分配到任一干预组。两种干预措施均每周进行一次，为期4周。在干预前（T1）、干预结束后1周（T2）和8周（T3）收集问卷、每日睡眠日志和客观评估的睡眠数据。在四次干预课程结束时，将评估参与者报告的对干预的满意度。
我们估计将招募50个二元组（50名患者和50名照顾者；每个干预组25个二元组）。在两种情况下，我们预计>75%符合条件并经过筛选的二元组将在招募期内同意参与，>80%登记的二元组将完成干预，并且>80%的参与者将在所有可接受性指标上报告满意。此外，我们将探讨MSOS和BBTI-CC是否对总体睡眠障碍、失眠严重程度以及与健康相关的生活质量产生相似的影响。结果将为进行简短的二元睡眠干预的可行性和可接受性提供信息，并提供初步数据，以指导在全面试验中进一步完善针对成年癌症患者及其床伴照顾者的干预内容和程序。
NCT06569693 美国国立医学图书馆临床试验注册库，于2024年8月22日注册，https://register.
gov/prs/app/action/SelectProtocol?sid=S000ESX9&selectaction=Edit&uid=U0005GPT&ts=2&cx=nb0aq5 。
