BREast Cancer And Sexuality Treatment (BREAST)

May 8, 2023 updated by: Lori Brotto, University of British Columbia

Mindfulness-based Treatment for Sexual Difficulties Following Breast Cancer

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5M 1M9
        • UBC Sexual Health Lab, Vancouver Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Behavioral: MBCT-S
Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.
Active Comparator: SexEd
Sexuality education on sexual desire, sexual distress, and sexual pain.
Behavioral: SexEd
Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 2 weeks' post-treatment
Time Frame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 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.
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
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.
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
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.
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
Time Frame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 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.
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
Time Frame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
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.
Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
No Change in Female Sexual Distress Scale - Revised (FSDS-R) Score from T2 at 2 weeks' post-treatment and at 6 month follow-up
Time Frame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
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.
T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
A Change from Baseline Sexual Pain Rating Score at 2 weeks' post-treatment
Time Frame: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
A Change from Baseline Sexual Pain Rating Score at 6 month follow-up
Time Frame: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
No Change in Sexual Pain Rating Score from 2 weeks' post-treatment and at 6 month follow-up
Time Frame: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H19-02480

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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