Online Sexual Health Program for Breast Cancer Survivors
(SHINE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. In fact, ongoing treatments like endocrine therapy and certain cancer medications are allowed during the study.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications. In fact, ongoing treatments like adjuvant endocrine therapy and certain other cancer-related medications are allowed during the study.
Is the Online Sexual Health Program for Breast Cancer Survivors safe for humans?
How is the SHINE Program treatment different from other treatments for sexual health issues in breast cancer survivors?
The SHINE Program is unique because it is an online sexual health program specifically designed for breast cancer survivors, making it widely accessible and comfortable for participants. Unlike traditional in-person counseling, it offers a self-help approach that can be accessed from anywhere, potentially increasing its reach and convenience for users.12467
How is the SHINE Program treatment different from other treatments for sexual health in breast cancer survivors?
The SHINE Program is unique because it is an online sexual health program specifically designed for breast cancer survivors, making it widely accessible and comfortable for participants. Unlike traditional in-person counseling, it offers a self-help approach that can be accessed from anywhere, potentially increasing its reach and convenience for users.12467
What data supports the effectiveness of the SHINE Program treatment for breast cancer survivors?
Research shows that group-based sexual education can effectively improve sexual behaviors in women with breast cancer, similar to individual counseling. Additionally, online self-help interventions have been beneficial for sexual problems after cancer, suggesting that the SHINE Program, which is an online sexual health program, may also be effective.12458
What data supports the effectiveness of the SHINE Program treatment for breast cancer survivors?
Research shows that group-based sexual education can effectively improve sexual behaviors in women with breast cancer, similar to individual counseling. Additionally, online self-help interventions have been beneficial for sexual problems after cancer, suggesting that the SHINE Program, which is an online sexual health program, may also be effective.12458
Who Is on the Research Team?
Glenn Lesser, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for cisgender female breast cancer survivors who are at least 18 years old, have finished primary cancer treatments like chemotherapy or surgery at least 12 weeks ago, and are currently in an intimate relationship. They should be somewhat bothered by sexual issues such as low interest, dryness, pain during sex, or orgasm difficulties due to their cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete the SHINE program, which includes various web-based educational and interactive components tailored to address sexual health concerns over a 12-week period.
Follow-up
Participants are monitored for changes in sexual distress and other outcomes through questionnaires administered at 12 and 24 weeks after the start of the study.
What Are the Treatments Tested in This Trial?
Interventions
- SHINE Program
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
University of Virginia
Collaborator