Sexual DysfunctionBREASTNCT04472104
BREast Cancer And Sexuality Treatment
A study testing MBCT-S and SexEd in people with Sexual Dysfunction, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- MBCT-S and SexEd
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jan 2020to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
UBC Sexual Health Lab, Vancouver Hospital
Vancouver, British Columbia, V5M 1M9
About this study
Official title: 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.
- Conditions
- Sexual Dysfunction
- Being tested
- MBCT-S, SexEd
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT-SBehavioural
Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.
SexEdBehavioural
Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-S | Active comparator | 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. Receives: Behavioral: MBCT-S |
| SexEd | Active comparator | Sexuality education on sexual desire, sexual distress, and sexual pain. Receives: Behavioral: SexEd |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
Measured: 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
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
Measured: 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
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
Measured: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start6 Jan 2020
- Primary completion1 Dec 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472104
- Sponsor's protocol ID
- H19-02480
- Acronym
- BREAST
- Status last verified
- May 2022
- First submitted
- 19 Nov 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Treatment for Sexual Difficulties Following Breast Cancer
- ClinicalTrials.gov ID
- NCT04472104
- Acronym / sponsor ID
- BREAST / H19-02480
- Conditions
- Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MBCT-S | Active comparator | Behavioral: MBCT-SMindfulness-Based Cognitive Therapy for sexuality (MBCT-S) which incorporates several empirically supported therapeutic approaches, integrating elements of education, mindfulness meditation skills, and sex therapy. |
| SexEd | Active comparator | Behavioral: SexEdSexuality education on sexual desire, sexual distress, and sexual pain. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCT-SGroup mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors. | Behavioural | MBCT-S |
| SexEdGroup sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors. | Behavioural | SexEd |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT-S and SexEd in people with Sexual Dysfunction, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.