Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial
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.
Inclusion Criteria
- 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
- Female
- Currently in an intimate relationship, as reported on the PROMIS SexFS screener (this relationship may be with an individual of any sex)
- 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
Exclusion Criteria
- Planned cancer treatment for residual, progressive, or recurrent disease within the 24 weeks following enrollment (defined as chemotherapy, cytotoxic antibody-drug conjugates, checkpoint inhibitors, radiation, and/or surgical procedures intended to remove malignant tissue). Ongoing adjuvant endocrine therapy (e.g., tamoxifen, aromatase inhibitors), adjuvant cdk 4/6-inhibitors (e.g., abemaciclib), 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
- Unable to read and comprehend English (SHINE intervention currently only available in English) as indicated by being unable to complete the self-reported screening questionnaire independently
- SELF-REPORTED ELIGIBILITY SCREENER EXCLUSION
- Does not have reliable access to internet (e.g., by home broadband, public network, personal data plan) by computer, tablet, smartphone etc. and is not willing to participate in the tablet lending program for this study
- Recent serious mental illness, as defined by reporting an inpatient psychiatric hospitalization within the past 12 months
- Currently participating in couple, marital, or sex therapy
- Currently pregnant (Pregnant women are excluded from this study because childbirth is accompanied by significant biological, psychological, and environmental changes that alter a woman’s sexual functioning. Intervention content may not be medically appropriate for women who have recently given birth, given that medical providers commonly recommend that women avoid sexual contact for at least four to six weeks post-partum while healing.)
Additional locations may be listed on ClinicalTrials.gov for NCT06216574.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationWake Forest NCORP Research Base
Principal InvestigatorKelly Shaffer
- Primary IDWF-2202
- Secondary IDsNCI-2023-06866
- ClinicalTrials.gov IDNCT06216574