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

项目摘要/摘要 大多数乳腺癌幸存者都经历过性问题，影响了他们的性功能。这些 担忧可能会对幸存者的关系和心理健康产生长期的负面影响。 然而，与乳腺癌幸存者的生活质量(QOL)的其他方面不同，这些方面往往会随着时间的推移而改善， 性问题通常不会在没有干预的情况下得到解决。解决乳腺癌幸存者的性行为 因此，关注和改善她们的性功能对她们的长期适应至关重要。然而，有一个 缺乏针对乳腺癌幸存者性功能的经验支持的干预措施。因为 夫妻关系在女性性功能中的不可或缺的作用，一种系统的干预 让伴侣参与很可能是解决性问题和提高存活率的有效方法 结果。在此之前，我们演示了基于4次会话的夫妻亲密关系增强(IE) 通过电话提供的干预改善了面临结直肠癌的夫妇的性行为和关系结果 癌症。在采用IE干预措施以满足乳腺癌幸存者的需求后，来自一项试点随机对照试验的数据 在29名乳腺癌幸存者和他们的伴侣中，建议IE干预是可行和可接受的，2 对患者的性功能和相关的患者和伴侣的结果有希望的影响大小。主要目标 这项研究的目的是评估新型夫妇IE介入治疗120例乳腺癌的疗效 幸存者和他们的亲密伴侣。夫妇将随机接受IE干预或 先前测试的注意力控制条件(健康生活在一起；LHT)。将进行评估 在治疗前、治疗后、3个月和6个月随访患者和伴侣。主要目标是 (目标1)是检查IE干预是否能显著改善患者的性功能 与LHT干预组的功能比较。这两个次要目的是评估IE干预是否 显著改善性伴侣的性功能(目标2a)以及患者和伴侣 亲密关系、质量和心理困扰(目标2b)，与低血压状态相比。我们会 还要检查对患者性功能的治疗效果是否通过性交流和 处理性问题的自我效能(目标3)。最后，为可能的下一步干预提供信息 发展，一个探索性目标是检查患者的年龄或种族/民族是否适度的IE干预 对病人性功能的影响。这项研究将是第一个基于夫妇的随机对照试验 针对乳腺癌幸存者的性功能干预以及第一次对其进行评估 心理社会干预改善癌症女性性功能的机制。调查结果： 本研究对乳腺癌患者的临床护理具有重要的理论指导意义。 与癌症相关的性康复，并最终对被诊断患有癌症的妇女的健康和福祉 乳腺癌和他们的亲密伴侣。

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.