BREast Cancer And Sexuality Treatment

University of British Columbia118 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

118

Conditions

Sexual Dysfunction

Interventions

MBCT-SBEHAVIORAL

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

SexEdBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

UBC Sexual Health Lab, Vancouver Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 2 weeks' post-treatment

Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning.

Time frame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment

A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 6 month follow-up

Time frame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up

No Change in Sexual Interest and Desire Female (SIDI-F) Score from 2 weeks' post-treatment (T2) and at 6 month follow-up (T3)

Time frame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up

A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 2 weeks' post-treatment

Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress.

Time frame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment

A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 6 month follow-up

Data from ClinicalTrials.gov

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