Status:
ACTIVE_NOT_RECRUITING
Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
University of Virginia
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to develop an effective internet-delivered program to help breast cancer survivors manage cancer-related sexual concerns. This study is being done to find out if th...
Detailed Description
This study has sixteen study groups with about twenty people in each group. Different groups receive different combinations of help. Participants will receive a certain combination of these four diffe...
Eligibility Criteria
Inclusion
- 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), 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.)
- Age ≥ 18 years at the time of study enrollment
- SELF-REPORTED ELIGIBILITY SCREENER INCLUSION
- female
- 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)
- 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
- 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.)
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06216574
Start Date
March 14 2024
End Date
August 1 2027
Last Update
April 15 2025
Active Locations (236)
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1
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
2
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States, 72903
3
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, United States, 94531
4
Kaiser Permanente Dublin
Dublin, California, United States, 94568