Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial
Breast Cancer
Unknown Primary
18 Years and older, Female
WF-2202 (primary)
WF-2202
WF-2202
NCI-2023-06866
Summary
This clinical trial develops and implements an internet-delivered sexual health program for breast cancer survivors. Sexual morbidity is common and distressing among breast cancer survivors. Cancer and cancer treatment can cause physical, psychological, and relational problems that lead to sexual morbidity, or problems with sexual distress and dysfunction. Despite the prevalence of this profound and long-term consequence of cancer treatment, there continues to be a lack of communication about sexual morbidity between oncologists and survivors, especially with female survivors. The development and implementation of an internet-delivered sexual health program may help breast cancer survivors manage cancer-related sexual concerns.
Objectives
PRIMARY OBJECTIVE:
I. To identify which combination of four intervention components produces the greatest benefit for survivors experiencing breast cancer-related sexual morbidity with the least intervention burden.
EXPLORATORY OBJECTIVES:
I. To examine how the four intervention components work, any differential response to intervention components, and survivors’ engagement, satisfaction, and perceived utility of the components.
Ia. To improve understanding of how the four intervention components work;
Ib. To improve understanding of any differential response to intervention components;
Ic. To improve understanding of survivors' engagement and satisfaction with the components;
Id. To improve understanding of survivors’ perceived utility of the components.
OUTLINE: Patients are randomized to 1 of 16 conditions.
CONDITION I: Patients receive access to SHINE intervention modules that include enhanced sexual health essentials about cancer-related sexual morbidity with access to a tailored and interactive web-based educational resource using animation, interactive elements, and quizzes to encourage retention of knowledge on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with clinicians, training to increase self-efficacy and capability for discussing sexual concerns with an intimate partner and techniques to build physical intimacy on study. Patients participate in the SHINE program over 24-week period.
CONDITION II: Patients receive access to SHINE intervention modules that include enhanced sexual health essentials about cancer-related sexual morbidity with access to a tailored and interactive web-based educational resource using animation, interactive elements, and quizzes to encourage retention of knowledge on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with clinicians and training to increase self-efficacy and capability for discussing sexual concerns with an intimate partner on study. Patients participate in the SHINE program over a 24-week period.
CONDITION III: Patients receive access to SHINE intervention modules that include enhanced sexual health essentials about cancer-related sexual morbidity with access to a tailored and interactive web-based educational resource using animation, interactive elements, and quizzes to encourage retention of knowledge on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with clinicians and techniques to build physical intimacy on study. Patients participate in the SHINE program over a 24-week period.
CONDITION IV: Patients receive access to SHINE intervention modules that include enhanced sexual health essentials about cancer-related sexual morbidity with access to a tailored and interactive web-based educational resource using animation, interactive elements, and quizzes to encourage retention of knowledge on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with clinicians on study. Patients participate in the SHINE program over a 24-week period.
CONDITION V: Patients receive access to SHINE intervention modules that include enhanced sexual health essentials about cancer-related sexual morbidity with access to a tailored and interactive web-based educational resource using animation, interactive elements, and quizzes to encourage retention of knowledge on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with an intimate partner and techniques to build physical intimacy on study. Patients participate in the SHINE program over a 24-week period.
CONDITION VI: Patients receive access to SHINE intervention modules that include enhanced sexual health essentials about cancer-related sexual morbidity with access to a tailored and interactive web-based educational resource using animation, interactive elements, and quizzes to encourage retention of knowledge on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with an intimate partner on study. Patients participate in the SHINE program over a 24-week period.
CONDITION VII: Patients receive access to SHINE intervention modules that include enhanced sexual health essentials about cancer-related sexual morbidity with access to a tailored and interactive web-based educational resource using animation, interactive elements, and quizzes to encourage retention of knowledge on study. Patients also receive techniques to build physical intimacy on study. Patients participate in the SHINE program over a 24-week period.
CONDITION VIII: Patients receive access to SHINE intervention modules that include enhanced sexual health essentials about cancer-related sexual morbidity with access to a tailored and interactive web-based educational resource using animation, interactive elements, and quizzes to encourage retention of knowledge on study. Patients participate in the SHINE program over a 24-week period.
CONDITION IX: Patients receive access to SHINE intervention modules that include standard sexual health essentials content from publicly available educational materials regarding breast cancer-related sexual health on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with clinicians, training to increase self-efficacy and capability for discussing sexual concerns with an intimate partner and techniques to build physical intimacy on study. Patients participate in the SHINE program over a 24-week period.
CONDITION X: Patients receive access to SHINE intervention modules that include standard sexual health essentials content from publicly available educational materials regarding breast cancer-related sexual health on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with clinicians and training to increase self-efficacy and capability for discussing sexual concerns with an intimate partner on study. Patients participate in the SHINE program over a 24-week period.
CONDITION XI: Patients receive access to SHINE intervention modules that include standard sexual health essentials content from publicly available educational materials regarding breast cancer-related sexual health on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with clinicians and techniques to build physical intimacy on study. Patients participate in the SHINE program over a 24-week period.
CONDITION XII: Patients receive access to SHINE intervention modules that include standard sexual health essentials content from publicly available educational materials regarding breast cancer-related sexual health on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with clinicians on study. Patients participate in the SHINE program over a 24-week period.
CONDITION XIII: Patients receive access to SHINE intervention modules that include standard sexual health essentials content from publicly available educational materials regarding breast cancer-related sexual health on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with an intimate partner and techniques to build physical intimacy on study. Patients participate in the SHINE program over a 24-week period.
CONDITION XIV: Patients receive access to SHINE intervention modules that include standard sexual health essentials content from publicly available educational materials regarding breast cancer-related sexual health on study. Patients also receive training to increase self-efficacy and capability for discussing sexual concerns with an intimate partner on study. Patients participate in the SHINE program over a 24-week period.
CONDITION XV: Patients receive access to SHINE intervention modules that include standard sexual health essentials content from publicly available educational materials regarding breast cancer-related sexual health on study. Patients also receive techniques to build physical intimacy on study. Patients participate in the SHINE program over a 24-week period.
CONDITION XVI: Patients receive access to SHINE intervention modules that include standard sexual health essentials content from publicly available educational materials regarding breast cancer-related sexual health on study. Patients participate in the SHINE program over a 24-week period.
After completion of study intervention, patients are followed up at 24 weeks post baseline assessment.
Eligibility
- History of stage 0-III breast cancer diagnosis. History of non-breast malignancies are permitted.
- = 12 weeks following last primary cancer treatment. For this protocol, primary cancer treatments are defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and surgical procedures intended to remove malignant tissue. Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), human epidermal growth factor receptor 2 (HER2)-based monoclonal antibody therapy (e.g., trastuzumab, pertuzumab), HER2 targeted tyrosine kinase inhibitors (e.g., neratinib), and/or pending breast reconstructive surgery are allowed. (There is no upper limit on time since treatment. Participants must endorse current sexual morbidity that they believe is related to their breast cancer. Breast cancer-related sexual morbidity often persists, or even worsens, years following treatment)
- Age = 18 years at the time of study enrollment
- SELF-REPORTED ELIGIBILITY SCREENER INCLUSION
- Cisgender female (i.e., assigned female at birth, female gender identity)
- Currently in an intimate relationship, as reported on the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction (PROMIS SexFS) screener (this relationship may be with an individual of any sex and gender identity)
- Endorse being at least "somewhat" bothered by >=1 of the following during the last 30 days: (lack of) interest in sexual activity, vaginal dryness, pain during sexual activity, or (in)ability to orgasm, as reported on the PROMIS SexFS Bother Regarding Sexual Function screener
- Endorse that = 1 of the bothersome sexual symptoms, from the PROMIS SexFS Bother Regarding Sexual Function screener is related to their breast cancer
- Has a working email address (or willing to create one) and receive emails from the study
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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