Clinical trial · Interventional
An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer
An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
- 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)
Diagnosis and treatment of breast cancer often leads to lower levels of sexual desire, decreased sexual arousal, painful intercourse, and difficulties achieving orgasm, and thus adversely impacts sexual functioning and intimacy. Despite the overwhelming evidence that many couples experience sexual distress following breast cancer, very few interventions have been designed exclusively to address these concerns. The purpose of this study is to develop and evaluate an online psychosexual program geared to the unique needs of couples experiencing sexual distress after breast cancer. This study will utilize a web-based approach, allowing couples to participate in the program from the privacy and comfort of their homes, and providing a resource to couples who may not otherwise be able to readily access support. Accordingly, this project has the potential for widespread positive impact for couples affected by breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychosexual Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Psychosexual Intervention
- description
- The intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing.
- interventionNames
- Behavioral: Psychosexual Intervention
Primary outcomes (1)
- measure
- Change in Sexual Function Questionnaire for Men and Women (SFQ-W, SFW-M) scores from pre (0 weeks) to post-treatment (6 weeks), and 3 month follow-up
- timeFrame
- pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
- description
- The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.
Secondary outcomes (7)
- measure
- Revised Dyadic Adjustment Scale (RDAS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: -Patient has received a diagnosis within the last 5 years of invasive breast carcinoma (non- metastatic), or ductal carcinoma in-situ * Patient has received a mastectomy or lumpectomy and undergone adjuvant therapy (i.e. chemotherapy, radiation, tamoxifen) * Patient is at least 1 month post-treatment. * Couples are in a committed relationship of at least 3 months duration at the time of diagnosis * Participants must be fluent in English * Participants must be 80 years of age or younger * Participants will require convenient access to a computer with a reliable internet connection in a private setting and have access to videoconferencing software (available for download at no cost). Exclusion Criteria: * One or both of the partners are currently struggling with any mental illness that would interfere with the ability to participate (e.g. actively suicidal; currently psychotic * Couples who plan to participate in couples or sex counselling during the study * Couples experiencing significant levels of relationship distress (e.g. presence of violence or abuse), in which case they will be referred for couple counseling
References
Publications (0)
Data not yet available