开启对话：一项评估基于夫妇的干预措施以减少年轻成年乳腺癌和妇科癌症幸存者夫妇生殖和性困扰的 III 期试验方案。
Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples.
机构信息
College of Public Health & Human Sciences, School of Social & Behavioral Health Sciences, Oregon State University, 2250 SW Jefferson Way, Corvallis, OR, 97330, USA.
Connell School of Nursing, Boston College, 140 Commonwealth Ave, Chestnut Hill, MA, 02467, USA.
出版信息
Trials. 2022 Sep 2;23(1):730. doi: 10.1186/s13063-022-06665-3.
BACKGROUND
Reproductive and sexual health (RSH) concerns are common and distressing for young adults diagnosed with breast and gynecologic cancer and their partners. This study evaluates the efficacy of a virtual couple-based intervention called Opening the Conversation (OC). The OC intervention is grounded in theory and evidence-based practice and was adapted to improve coping and communication specifically in relation to RSH concerns after cancer.
METHODS
This Phase III trial is conducted in a fully remote setting and enrolls young adult couples (current age 18-44 years) with a history of breast or gynecologic cancer (stage 1-4, diagnosed under age 40) within the past 6 months to 5 years. Eligible dyads are recruited from across the USA. The target sample size is 100 couples. Dyads are randomly assigned to receive either the 5-session OC intervention or a 4-session active control intervention (Side by Side). The primary outcomes are change in reproductive distress and sexual distress. Secondary outcomes include communication about reproductive concerns, communication about sexual concerns, depressive symptoms, sexual function, relationship quality, relationship intimacy, sexual satisfaction, self-efficacy to communicate about sex and intimacy, and quality of life. An exploratory aim examines whether dyadic coping and communication quality mediate intervention effects on survivors' and partners' reproductive distress or sexual distress. Self-report outcome measures are assessed for both groups at baseline (T1), 2 weeks post-treatment (T2), and 3 months post-treatment (T3).
DISCUSSION
Despite the importance of RSH for quality of life for young adult cancer survivors and their partners, evidence-based interventions that help couples navigate RSH concerns are lacking. This randomized controlled trial will determine the efficacy of a novel couple-based intervention to reduce distress related to RSH concerns for younger couples after breast or gynecologic cancer, in comparison to an active control intervention.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04806724. Registered on Mar 19, 2021.
背景
生殖和性健康（RSH）问题在被诊断患有乳腺和妇科癌症的年轻患者及其伴侣中很常见，且令人困扰。本研究评估了一种名为“开启对话”（OC）的虚拟基于伴侣的干预措施的有效性。OC 干预措施基于理论和循证实践，并进行了调整，以专门改善与癌症后 RSH 相关的应对和沟通。
方法
这项 III 期试验是在完全远程环境中进行的，招募了过去 6 个月至 5 年内患有乳腺或妇科癌症（1-4 期，40 岁以下诊断）的年轻成年夫妇（当前年龄 18-44 岁）。符合条件的伴侣是从美国各地招募的。目标样本量为 100 对。伴侣被随机分配接受 5 节 OC 干预或 4 节积极对照干预（并肩）。主要结果是生殖困扰和性困扰的变化。次要结果包括生殖问题沟通、性问题沟通、抑郁症状、性功能、关系质量、关系亲密、性满意度、沟通性和亲密感的自我效能、生活质量。一个探索性目标是检查伴侣应对和沟通质量是否调节干预对幸存者和伴侣生殖困扰或性困扰的影响。两组在基线（T1）、治疗后 2 周（T2）和治疗后 3 个月（T3）时都要评估自我报告的结果。
讨论
尽管 RSH 对年轻癌症幸存者及其伴侣的生活质量很重要，但缺乏帮助伴侣应对 RSH 问题的循证干预措施。这项随机对照试验将确定一种新的基于伴侣的干预措施对减少年轻夫妇乳腺或妇科癌症后与 RSH 相关的困扰的疗效，与积极对照干预相比。
试验注册
ClinicalTrials.gov NCT04806724。注册于 2021 年 3 月 19 日。
Zotero 插件