Addressing Sexual Concerns in Breast Cancer Survivors: RCT of a Novel Couple-Based Intervention

解决乳腺癌幸存者的性问题：基于夫妻的新型干预措施的随机对照试验

• 批准号: 10242756
• 负责人: Jennifer Barsky Reese
• 金额: $ 62.02万
• 依托单位: RESEARCH INST OF FOX CHASE CAN CTR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-04 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10242756
• 关键词: Acute; Address; Aftercare; Age; Behavioral; Breast Cancer survivor; Clinical Practice Guideline; Cognitive; Colorectal Cancer; Communication; Couples; Data; Diagnosis; Distress; Educational Materials; Emotional; Ethnic Origin; Evaluation; Fatigue; Female Breast Carcinoma; Health; Individual; Intervention; Lead; Malignant Neoplasms; Mediating; Mediator of activation protein; Outcome; Pain; Patient-Focused Outcomes; Patients; Personal Satisfaction; Pilot Projects; Play; Population; Quality of life; Race; Randomized; Randomized Controlled Trials; Rehabilitation therapy; Reporting; Role; Sampling; Self Efficacy; Sex Functioning; Sexual Partners; Survivors; Telephone; Testing; Time; Training and Education; Treatment Efficacy; Well in self; Woman; attentional control; base; breast surgery; chemotherapy; clinical care; clinically significant; coping; efficacy evaluation; efficacy testing; experience; follow-up; hormone therapy; improved; improved functioning; innovation; intervention effect; intimate behavior; malignant breast neoplasm; novel; pilot trial; primary outcome; psychological distress; psychological outcomes; psychosocial; public health relevance; sex; sexual relationship; skills; skills training; social cognitive theory; theories; therapy development; treatment effect

PROJECT SUMMARY/ABSTRACT The majority of breast cancer survivors experience sexual concerns impacting their sexual function. These concerns can have long-term negative consequences on survivors’ relationships and psychological well-being. Yet unlike other aspects of quality of life (QOL) that tend to improve over time for breast cancer survivors, sexual concerns do not typically resolve without intervention. Addressing breast cancer survivors’ sexual concerns and improving their sexual function is thus critical to their long-term adjustment. However, there is a lack of empirically supported interventions targeting sexual function in breast cancer survivors. Because of the integral role that the couple relationship plays in women’s sexual function, an intervention that systematically involves the partner is likely to be an effective approach for addressing sexual concerns and improving survivor outcomes. Previously, we demonstrated that a 4-session couple-based Intimacy Enhancement (IE) intervention delivered via telephone improved sexual and relationship outcomes for couples facing colorectal cancer. After adapting the IE intervention to meet the needs of breast cancer survivors, data from a pilot RCT in 29 breast cancer survivors and their partners suggest the IE intervention to be feasible and acceptable, 2ith promising effect sizes on patient sexual function and related patient and partner outcomes. The main objective of the proposed study is to evaluate the efficacy of the novel couple-based IE intervention in 120 breast cancer survivors and their intimate partners. Couples will be randomized to receive either the IE intervention or to a previously tested attention control condition (Living Healthy Together; LHT). Assessments will be conducted with patients and partners at pre-treatment, post-treatment, and 3- and 6-months follow up. The primary aim (Aim 1) is to examine whether the IE intervention leads to a significantly greater improvement in patient sexual function compared to the LHT intervention. The two secondary aims are to evaluate whether the IE intervention leads to significantly greater improvements in partner sexual function (Aim 2a) and in patient and partner relationship intimacy and quality and psychological distress (Aim 2b), compared to the LHT condition. We will also examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns (Aim 3). Finally, to inform potential next steps in intervention development, an exploratory aim is to examine whether patient age or race/ethnicity moderate IE intervention effects on patient sexual function. This study will be the first randomized controlled trial of a couple-based intervention targeting sexual function for breast cancer survivors, as well as the first to first to evaluate mechanisms by which a psychosocial intervention improves sexual function for women with cancer. Findings of this study could have a significant impact on clinical care for women with breast cancer, on the theory guiding cancer-related sexual rehabilitation, and ultimately, on the health and well-being of women diagnosed with breast cancer and their intimate partners.

项目摘要/摘要 大多数乳腺癌的存活都经历了影响其性功能的性关注。这些 担忧可能会对生存的关系和心理健康产生长期的负面影响。 然而，与生活质量的其他方面（QOL）不同，这些方面倾向于随着时间的流逝而改善乳腺癌的生存， 性问题通常不会在没有干预的情况下解决。解决乳腺癌存活的性 因此，关注和改善其性功能对于他们的长期调整至关重要。但是，有一个 缺乏针对乳腺癌存活中性功能的经验支持的干预措施。因为 这对夫妻关系在女性的性功能中扮演的不可或缺的角色，这种干预措施有系统地 涉及伴侣可能是解决性问题和改善幸存者的有效方法 结果。以前，我们证明了一个基于4条的夫妻亲密感（IE） 通过电话提供的干预改善了面对结直肠的情侣的性和关系成果 癌症。调整IE干预以满足乳腺癌存活的需求之后，Pilot RCT的数据 在29个乳腺癌存活中及其伴侣认为IE干预是可行和可接受的，2ith 对患者性功能以及相关患者和伴侣结果的有希望的效果大小。主要目标 拟议的研究是评估新型夫妇IE干预对120个乳腺癌的有效性 幸存者及其亲密伴侣。夫妻将被随机接受IE干预或 先前测试的注意力控制条件（一起健康； LHT）。评估将进行 患者和伴侣进行治疗，治疗后以及3个月和6个月的随访。主要目的 （AIM 1）检查IE干预是否会导致患者性行为的改善明显改善 与LHT干预相比的功能。两个次要目标是评估IE干预是否 导致伴侣性功能（AIM 2A）以及患者和伴侣的性功能显着改善 与LHT条件相比，关系亲密关系，质量和心理困扰（AIM 2B）。我们将 还检查治疗对患者性功能的影响是否是通过性交流介导的 应对性关注的自我效能感（AIM 3）。最后，为干预的潜在下一步告知 开发，探索性目的是检查患者年龄或种族/种族/种族是否适度IE干预 对患者性功能的影响。这项研究将是基于夫妇的第一个随机对照试验 针对乳腺癌存活的性功能的干预措施，以及首先要评估的性功能 社会心理干预改善癌症女性的性功能的机制。发现 这项研究可能会对乳腺癌女性的临床护理产生重大影响，对理论指导 与癌症有关的性康复，最终是关于诊断患有妇女的健康和福祉 乳腺癌及其亲密伴侣。