Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial

Active:	Yes
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT06216574
Trial Phases:	Phase II	Protocol IDs:	WF-2202 (primary) WF-2202 WF-2202 NCI-2023-06866
Eligibility:	18 Years and older, Female	Study Type:	Supportive care
Study Sponsor:	Wake Forest NCORP Research Base
NCI Full Details:	http://clinicaltrials.gov/show/NCT06216574

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.

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