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Behavioural Intervention
Online Sexual Health Program for Breast Cancer Survivors (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
No Placebo-Only Group
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,401 Previous Clinical Trials
2,459,985 Total Patients Enrolled
39 Trials studying Breast Cancer
1,346,547 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,773 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,132 Patients Enrolled for Breast Cancer
University of VirginiaOTHER
785 Previous Clinical Trials
1,316,126 Total Patients Enrolled
11 Trials studying Breast Cancer
2,142 Patients Enrolled for Breast Cancer
Glenn Lesser, MDStudy ChairWake Forest University Health Sciences
4 Previous Clinical Trials
2,538 Total Patients Enrolled