Cancer Prevention and Control Program, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA, 19111, USA.
Department of Social and Behavioral Sciences, College of Public Health, Temple University, 1301 Cecil B. Moore Avenue, Ritter Annex, Philadelphia, PA, 19122, USA.
Trials. 2020 Feb 12;21(1):173. doi: 10.1186/s13063-019-3975-2.
Sexual concerns are distressing for breast cancer survivors and interfere with their intimate relationships. This study evaluates the efficacy of a four-session couple-based intervention delivered via telephone, called Intimacy Enhancement (IE). The IE intervention is grounded in social cognitive theory and integrates evidence-based techniques from cognitive behavioral couple therapy and sex therapy to address survivors' sexual concerns and enhance their and their partners' sexual, relationship, and psychological outcomes.
This trial is designed to evaluate the efficacy of the IE intervention in improving survivors' sexual function, the primary study outcome. Secondary outcomes include survivors' sexual distress, partners' sexual function, and survivors' and partners' relationship intimacy and quality as well as psychological distress (depressive symptoms and anxiety symptoms). Additional aims are to examine whether treatment effects on patient sexual function are mediated by sexual communication and self-efficacy for coping with sexual concerns and to explore whether survivor age and race/ethnicity moderate intervention effects on survivors' sexual function. Eligible adult female breast cancer survivors reporting sexual concerns and their intimate partners are recruited from two academic sites in the USA and are randomized to either the IE intervention or to a control condition of equal length offering education and support around breast cancer-related health topics (Living Healthy Together). The target sample size is 120 couples. Self-report outcome measures are administered to participants in both conditions at baseline (T1), post-treatment (T2), 3 months post-treatment (T3), and 6 months post-treatment (T4).
Evidence-based interventions are needed to address sexual concerns for breast cancer survivors and to enhance their and their intimate partners' sexual, relationship, and psychological well-being. This randomized controlled trial will allow us to examine the efficacy of a novel couple-based intervention delivered via telephone for breast cancer survivors experiencing sexual concerns and their intimate partners, in comparison with an attention control. Findings of this study could influence clinical care for women with breast cancer and inform theory guiding cancer-related sexual rehabilitation.
ClinicalTrials.gov, NCT03930797. Registered on 24 April 2019.
性问题困扰着乳腺癌幸存者，并影响他们的亲密关系。本研究评估了一种通过电话提供的四节夫妻为基础的干预措施（称为增强亲密关系）的疗效。IE 干预基于社会认知理论，并整合了认知行为夫妻治疗和性治疗中的循证技术，以解决幸存者的性问题，并增强他们和他们的伴侣的性、关系和心理结果。
本试验旨在评估 IE 干预改善幸存者性功能的疗效，这是主要研究结果。次要结果包括幸存者的性困扰、伴侣的性功能以及幸存者和伴侣的关系亲密程度和质量以及心理困扰（抑郁症状和焦虑症状）。其他目的是检查治疗对患者性功能的影响是否通过性沟通和应对性问题的自我效能来介导，并探讨幸存者年龄和种族/民族是否调节干预对幸存者性功能的影响。符合条件的成年女性乳腺癌幸存者报告性问题及其亲密伴侣从美国的两个学术地点招募，并随机分配到 IE 干预组或长度相等的对照组，提供有关乳腺癌相关健康主题的教育和支持（共同健康生活）。目标样本量为 120 对夫妻。两组参与者在基线（T1）、治疗后（T2）、治疗后 3 个月（T3）和治疗后 6 个月（T4）时进行自我报告结果测量。
需要基于证据的干预措施来解决乳腺癌幸存者的性问题，并增强他们和他们亲密伴侣的性、关系和心理幸福感。这项随机对照试验将使我们能够比较一种新型的通过电话提供的夫妻为基础的干预措施，用于治疗有性问题的乳腺癌幸存者及其亲密伴侣，与注意力对照组相比。这项研究的结果可能会影响乳腺癌女性的临床护理，并为指导癌症相关性康复的理论提供信息。
ClinicalTrials.gov，NCT03930797。于 2019 年 4 月 24 日注册。
