Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, DUMC 102506, Durham, NC, 27710, USA.
Department of Psychology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Trials. 2022 Aug 26;23(1):712. doi: 10.1186/s13063-022-06656-4.
For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and their relationship. Prior studies have found evidence that couple-based communication skills interventions can to be beneficial for patients and partners. However, these studies have been limited by reliance on in-person treatment delivery and have not targeted couples at high risk for poor outcomes. This study tests the efficacy of a Couples Communication Skills Training (CCST) intervention delivered via videoconference for couples reporting high levels of holding back from discussing cancer-related concerns, a variable associated with poorer psychological and relationship functioning.
This RCT is designed to evaluate the efficacy of CCST in improving patient and partner relationship functioning (primary outcome). Secondary outcomes include patient and partner psychological functioning and patient symptoms and health care use. We also examine the role of objective and self-reported communication behaviors as mediators of treatment effects. Two hundred thirty patients with advanced lung, gastrointestinal, genitourinary, and breast cancer and their partners will be randomized to CCST or an education control intervention. Participants in both conditions complete self-reported outcome measures at baseline, mid-treatment, post-treatment, and 3 months post-treatment. Objective measures of communication are derived from video-recorded couple conversations collected at baseline and post-treatment. An implementation-related process evaluation (assessing implementation outcomes and potential barriers to/facilitators of implementation) will be conducted to inform future efforts to implement CCST in real-world settings.
This trial can yield important new knowledge about effective ways to improve patient and partner adjustment to advanced cancer.
This study trial is registered at clinicaltrials.gov (Trial # NCT04590885); registration date: October 19, 2020.
对于患者及其亲密伴侣来说，晚期癌症带来了巨大的挑战，这可能会对患者及其伴侣的个人生活和关系造成负面影响。既往研究表明，基于夫妻双方的沟通技巧干预对患者和伴侣可能是有益的。然而，这些研究受到了依赖面对面治疗的限制，而且并未针对那些有不良结局高风险的夫妻。本研究检验了通过视频会议提供的夫妻沟通技巧培训（CCST）干预措施对报告回避讨论癌症相关问题的夫妻的疗效，回避讨论与较差的心理和关系功能有关。
本 RCT 旨在评估 CCST 改善患者和伴侣关系功能（主要结果）的疗效。次要结果包括患者和伴侣的心理功能以及患者的症状和医疗保健使用。我们还研究了客观和自我报告的沟通行为作为治疗效果的中介变量的作用。将 230 名患有晚期肺癌、胃肠道癌、泌尿生殖系统癌和乳腺癌的患者及其伴侣随机分为 CCST 组或教育对照组。两组参与者在基线、治疗中期、治疗后和治疗后 3 个月完成自我报告的结果测量。基线和治疗后从视频记录的夫妻对话中得出沟通的客观指标。实施相关的过程评估（评估实施结果以及实施的障碍/促进因素）将进行，为今后在真实环境中实施 CCST 提供信息。
本试验可以为改善患者和伴侣对晚期癌症的适应提供新的有效方法。
本研究于 2020 年 10 月 19 日在 clinicaltrials.gov 上注册（试验 # NCT04590885）。
