BREast Cancer And Sexuality Treatment

NCT ID: NCT04472104

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2023-04-01

Brief Summary

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The purpose of this project is to compare the effects of a group mindfulness treatment versus a group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors. Participants will be randomly assigned to either 8 weekly sessions of a group mindfulness-based treatment or 8 weekly sessions of a sex education group. Groups will consist of approximately 8 breast cancer survivors and will be led by 2 trained therapists. Participants will complete four assessments (involving a clinician administered interview and standardized questions): pre-treatment, post- treatment, and 6 month follow up.

Detailed Description

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Conditions

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Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3-year, randomized, unblinded, two-site, controlled trial of 8 weekly sessions of group Mindfulness-Based Cognitive Therapy for sexuality (MBCT-S) vs. 8 weekly sessions of a sex education treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Those doing data analysis are blind

Study Groups

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MBCT-S

Mindfulness-Based Cognitive Therapy for sexuality (MBCT-S) which incorporates several empirically supported therapeutic approaches, integrating elements of education, mindfulness meditation skills, and sex therapy.

Group Type ACTIVE_COMPARATOR

MBCT-S

Intervention Type BEHAVIORAL

Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.

SexEd

Sexuality education on sexual desire, sexual distress, and sexual pain.

Group Type ACTIVE_COMPARATOR

SexEd

Intervention Type BEHAVIORAL

Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.

Interventions

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MBCT-S

Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.

Intervention Type BEHAVIORAL

SexEd

Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women over the age of majority, with a history of breast cancer and who are at least 3 months following the end of their treatment
* Fluent in English
* Exceed the clinical cut-off for sexual distress (Female Sexual Distress Scale).
* Women who are, and who are not, in a relationship will be eligible as long as they have engaged in sexual activity either alone or with a sexual partner in the past 6 months, or as long as they indicate a willingness to engage in sexual activity (alone or with a sexual partner) during the time period of the study.

Exclusion Criteria

* Active cancer treatment (e.g. chemotherapy or radiation, not including endocrine or maintenance therapies provided they remain constant for the study duration), or scheduled breast reconstruction during the study period.
* Borderline Personality Disorder or other psychiatric or medical conditions that preclude the ability to fully participate in the group sessions, assessments, and homework.
* In order to determine whether any changes in symptoms are a result of participation in the intervention, women must also agree to 1) not make changes to or commence vaginal interventions (e.g., topical hormone treatments, vaginal moisturizers, vaginal dilation) or 2) engage in other treatments for sexual difficulties (e.g., sex therapy), for 2 weeks prior to the baseline assessment until 2 weeks following the final intervention session.
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Lori Brotto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UBC Sexual Health Lab, Vancouver Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H19-02480

Identifier Type: -

Identifier Source: org_study_id

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