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

Major Program
Supportive Care and Symptom Management
NCI Community Oncology Research Program
Research Group
Community Oncology and Prevention Trials
Sponsor
Wake Forest University Health Sciences
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT06216574
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.
Intervention
Internet-based Intervention
Condition
Breast Cancer Female
Investigators
Glenn Lesser, MD, Glenn J Lesser, Joshua Lukenbill, Richard L Deming, Irene Decelie, Jay Carlson, Pamala Pawloski, Deborah Wilbur, Bryan Faller, Maria Grosse-Perdekamp, Bharat Jenigiri, Michelle Loch, Gregory Masters, Timothy D Moore, , Vinay Gudena, William Burak, Sigrun Hallmeyer, Natalya Greyz-Yusupov, Natalya Greyz-Yusopov, Daniel Almquist, Dalniel Almquist, Alison Conlin, Antonio Ruiz, Elizabeth DesJardin, Rose Juhasz, Bret Friday, Kathleen Yost, Leanna Fendley, Amy Curtis, Faith Goldman, Emily Pohl, Ami Chitalia, Shahzad Siddique, John Doster, Steven Madden, Mary Hackney, Erica Linden, Abirami Sivapiragasam, Dean Delmastro, John Ellerton, Eric Chen, Yadyra Rivera

See list of participating sites