NCT06216574

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
Wake Forest University Health Sciences·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Breast Cancer Female
Drug/Device/Intervention
Internet-based Intervention
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Wake Forest University Health Sciences
Location
Ankeny,Carroll,Clive,Clive,Des Moines,Des Moines,Des Moines,Des Moines,Des Moines,Fort Dodge,Winston-Salem, United States of America
Timeline & enrollment
Phase
N/A
Start date
Mar 14, 2024
End date
Aug 01, 2027
Enrollment
320 participants
Primary outcome

Change in sexual distress as measured by the total sum score of the Female Sexual Distress Scale - Desire, Arousal, Orgasm (FSDS-DAO). The total sum score ranges from 0-60 with higher scores reflecting greater distress.

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 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.

ICD-10 classifications
Malignant neoplasm: Breast, unspecifiedMalignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedPersonal history of malignant neoplasm of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06216574
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06216574 through Pure Global AI's free database. This phase not specified trial is sponsored by Wake Forest University Health Sciences and is currently Recruiting. The study focuses on Breast Cancer Female. Target enrollment is 320 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.