Clinical trial NCT04472104: BREast Cancer And Sexuality Treatment
Official title: Mindfulness-based Treatment for Sexual Difficulties Following Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2020-07-15
Enrollment: 118
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 2 weeks' post-treatment
timeFrame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
measure: A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 6 month follow-up
timeFrame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
measure: No Change in Sexual Interest and Desire Female (SIDI-F) Score from 2 weeks' post-treatment (T2) and at 6 month follow-up (T3)
timeFrame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
measure: A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 2 weeks' post-treatment
timeFrame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
measure: A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 6 month follow-up
timeFrame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
measure: No Change in Female Sexual Distress Scale - Revised (FSDS-R) Score from T2 at 2 weeks' post-treatment and at 6 month follow-up
timeFrame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
measure: A Change from Baseline Sexual Pain Rating Score at 2 weeks' post-treatment
timeFrame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
measure: A Change from Baseline Sexual Pain Rating Score at 6 month follow-up
timeFrame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
measure: No Change in Sexual Pain Rating Score from 2 weeks' post-treatment and at 6 month follow-up
timeFrame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC Sexual Health Lab, Vancouver Hospital
state: British Columbia
Study officials:
References: