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NCT06216574 · ClinicalTrials.gov registry record · NA
Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE Trial
A NA study of Breast Cancer Female, sponsored by Wake Forest University Health Sciences.
- Active
- Registry status
- NA
- Development phase
- 340
- Enrollment target
- 20
- Study locations
NCT06216574: Active NA study of Breast Cancer Female, sponsored by Wake Forest University Health Sciences.
NCT06216574 is a NA study of Breast Cancer Female that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 340 participants, below the 685-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06216574, a NA study of Breast Cancer Female, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 340 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Estimated mean change from Baseline to 24 weeks with main effect of Time will be obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants will be utilized in the model (ITT analysis).
Conditions Studied
Interventions
- OTHER Internet-based Intervention
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Kaiser Permanente Dublin - Dublin
- Kaiser Permanente-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- Kaiser Permanente-Modesto - Modesto
- Kaiser Permanente-Oakland - Oakland
- Kaiser Permanente- Marshall Medical Offices - Redwood City
- Kaiser Permanente-Richmond - Richmond
- Kaiser Permanente-Roseville - Roseville
- Kaiser Permanente Downtown Commons - Sacramento
- Kaiser Permanente-South Sacramento - Sacramento
- Kaiser Permanente-San Francisco - San Francisco
- Kaiser Permanente-Santa Teresa-San Jose - San Jose
- Kaiser Permanente San Leandro - San Leandro
- Kaiser San Rafael-Gallinas - San Rafael
- Kaiser Permanente Medical Center - Santa Clara - Santa Clara
- Kaiser Permanente-Santa Rosa - Santa Rosa
- Providence Medical Foundation - Santa Rosa - Santa Rosa
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2024-03-14 |
| Est. Completion | 2027-08-01 |
| Phase | NA |
What the registry record for NCT06216574 still lists
NCT06216574 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 685-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (50% lower).
The record links to 1 condition, with Breast Cancer Female appearing as the primary indexed condition, and to 1 intervention - of which Internet-based Intervention is the first listed.
NCT06216574 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06216574 about?
NCT06216574 is a clinical study titled "Developing an Internet-Delivered Sexual Health Program for Breast Cancer Survivors, SHINE 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 manag...
What is the current status of trial NCT06216574?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 340 participants. The study started on 2024-03-14. Estimated completion is 2027-08-01.
What conditions does trial NCT06216574 study?
This clinical trial studies the following conditions: Breast Cancer Female.
What interventions are being tested in trial NCT06216574?
The interventions under investigation include: Internet-based Intervention (OTHER).
Who is sponsoring clinical trial NCT06216574?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06216574 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer Female
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06216574's enrollment target sits among peer trials
340 11th of 46 higher than 36 of 46 other Breast Cancer Female trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Female trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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