Clinical trial · Interventional
BREast Cancer And Sexuality Treatment
Mindfulness-based Treatment for Sexual Difficulties Following Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MBCT-S | Behavioral | — | UNRESOLVED |
| SexEd | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MBCT-S
- description
- 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.
- interventionNames
- Behavioral: MBCT-S
- type
- ACTIVE_COMPARATOR
- label
- SexEd
- description
- Sexuality education on sexual desire, sexual distress, and sexual pain.
- interventionNames
- Behavioral: SexEd
Primary outcomes (9)
- measure
- A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 2 weeks' post-treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available