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Completed

NCT Number: NCT04472104

BREast Cancer And Sexuality Treatment

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.

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Key information

Conditions

Sexual Dysfunction Genital Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UBC Sexual Health Lab, Vancouver Hospital

Vancouver, British Columbia, V5M 1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MBCT-S

Behavioral

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

SexEd

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • University of Calgary

Registry information

Official study title

Mindfulness-based Treatment for Sexual Difficulties Following Breast Cancer

Acronym: BREAST

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jul 15, 2020
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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