Your session is about to expire
← Back to Search
Behavioural Intervention
SHINE 4 for Breast Cancer (SHINE Trial)
N/A
Recruiting
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 24 weeks
Awards & highlights
SHINE Trial Summary
"This trial aims to create an online program to help breast cancer survivors deal with sexual concerns related to cancer. Participants will be split into different groups and given access to the SHINE program, which provides education
Who is the study for?
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.Check my eligibility
What is being tested?
The SHINE Trial tests an internet-delivered program designed to help manage sexual health concerns after breast cancer. Participants will use the SHINE program with educational content and may receive additional modules on communication with clinicians and partners or increasing intimacy over a period of 24 weeks.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on education and support through an online platform, there are no direct physical side effects expected from participating in the SHINE Trial.
SHINE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
SHINE Trial Design
16Treatment groups
Experimental Treatment
Group I: SHINE 9Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Standard) - 20 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.
Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
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.
Group II: SHINE 8Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 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.
Group III: SHINE 7Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 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.
Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Group IV: SHINE 6Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 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 partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
Group V: SHINE 5Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - NONE, 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 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.
Group VI: SHINE 4Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 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.
Group VII: SHINE 3Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Enhanced) - 45 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 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.
Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Group VIII: SHINE 2Experimental Treatment1 Intervention
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.
Group IX: SHINE 16Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - NONE.
Each component is a single lesson accessed at participant's convenience and may be repeated.
Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
Group X: SHINE 15Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes.
Each component is a single lesson accessed at participant's convenience and may be repeated.
Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Group XI: SHINE 14Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 3) Communication with Partner - 45 minutes, 4) Intimacy - NONE.
Each component is a single lesson accessed at participant's convenience and may be repeated.
Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
Communication with partner provides effective models and exercises to practice clear communication regarding sexual concerns with partner.
Group XII: SHINE 13Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - NONE, 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.
Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
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.
Group XIII: SHINE 12Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy -NONE.
Each component is a single lesson accessed at participant's convenience and may be repeated.
Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.
Group XIV: SHINE 11Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Standard) - 20 minutes, 2) Communication with Clinician - 45 minutes, 3) Communication with Partner - NONE, 4) Intimacy - 45 minutes.
Each component is a single lesson accessed at participant's convenience and may be repeated.
Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
Communication with the clinician reviews clinical terminology to describe physical symptoms of sexual concern and potential scripts for discussion with an appropriate clinician.
Intimacy module provides strategies for increasing non-sexual intimacy, reconsidering sexual scripts, and focus exercises.
Group XV: SHINE 10Experimental Treatment1 Intervention
SHINE components assigned: 1) Psycho-education (Standard) - 20 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.
Standard psycho-education has content on effects of cancer on sexual function, self-image, and relationships, managing sexual concerns, and basic sexual anatomy.
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.
Group XVI: SHINE 1Experimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,410 Total Patients Enrolled
35 Trials studying Breast Cancer
5,087 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,121 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
University of VirginiaOTHER
754 Previous Clinical Trials
1,244,753 Total Patients Enrolled
10 Trials studying Breast Cancer
2,042 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for eligible individuals to participate in this ongoing research study?
"According to clinicaltrials.gov, this particular study is no longer in the recruitment phase. Initially shared on March 1st, 2024, with the most recent update also made on that same date. Despite its closure for participant enrollment, it's worth noting that there are currently 2365 ongoing trials actively seeking eligible individuals for participation."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger