Clinical trial · Interventional
Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial
Optimizing Psychosocial Intervention for Breast Cancer-Related Sexual Morbidity:The Sexual Health and Intimacy Education (SHINE) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 the study approach is better or worse than the usual approach to helping breast cancer survivors manage cancer-related sexual concerns. The usual approach is defined as care most cancer survivors get for their cancer-related sexual concerns. Participants will complete a questionnaire and if they qualify, they will be assigned to one of sixteen groups of participants. Groups will get access to various kinds of help through an Internet-delivered program called SHINE, which was designed and is run by researchers at the University of Virginia Center for Behavioral Health and Technology. All groups will get access to education about sexual health after cancer: either a standard education website or an enhanced education web program. Groups may also receive up to three additional web programs on: talking to your clinicians about sexual concerns, and/or talking to your partner about sexual concerns, and/or increasing intimacy. Participants are asked to complete the SHINE program within 12 weeks. After participants finish this 12-week period, the study team will ask them to complete a questionnaire to check in with the participant. The participant will be asked one additional time 12 weeks later to complete another questionnaire to see how the participant is doing. A participant will be in the study for 24 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Internet-based Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (16)
- type
- EXPERIMENTAL
- label
- SHINE 1
- description
- SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - 45 minutes Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner. Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
- interventionNames
- Other: Internet-based Intervention
- type
- EXPERIMENTAL
- label
- SHINE 2
- description
- SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE. Each component is a single lesson accessed at participant's convenience and may be repeated. Psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy. Enhanced version is tailored, interactive instruction and recommendations for over-the-counter products and aids. Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician. Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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), 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 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.)
References
Publications (2)
- DERIVEDShaffer KM, Glazer JV, Kittel CA, Dressler EV, Wood E, Lawson H, Reese JB, Danhauer SC, Showalter SL, Cohn W, Clayton AH, Weaver KE, Lesser GJ, Ritterband LM. Examining recruitment differences by race, ethnicity, and age to a decentralized trial of an internet-delivered intervention for sexual health after breast cancer: the WF-2202 SHINE trial. Support Care Cancer. 2026 Apr 25;34(5):465. doi: 10.1007/s00520-026-10686-y. PMID 42034715
- DERIVEDShaffer KM, Reese JB, Dressler EV, Glazer JV, Cohn W, Showalter SL, Clayton AH, Danhauer SC, Loch M, Kadi M, Smith C, Weaver KE, Lesser GJ, Ritterband LM. Factorial Trial to Optimize an Internet-Delivered Intervention for Sexual Health After Breast Cancer: Protocol for the WF-2202 Sexual Health and Intimacy Enhancement (SHINE) Trial. JMIR Res Protoc. 2024 Aug 19;13:e57781. doi: 10.2196/57781. PMID 39159450