An interventional study of Psychosexual Intervention in Breast Cancer, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged Up to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Supportive care
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.
Many couples experience sexual problems following breast cancer treatment, and difficulties with intimacy and sexuality tend to extend past the 1 year post-treatment point. Given that resources available for couples who experience sexual distress after breast cancer are virtually non-existent, there is a need to develop and empirically evaluate psychosexual interventions for breast cancer patients and their partners.
The purpose of this study is to evaluate the feasibility, process, and outcomes of an online, couples-based intervention designed to address sexual problems encountered by many couples facing breast cancer. The intervention will take place in the form of six E-therapy sessions delivered via secure, encrypted videoconferencing software commonly used by health care providers practicing telemedicine. Each session will be supplemented by psychoeducational materials (i.e. reading and/or video) available through a privately accessed homepage for the study.
Thirty couples will participate in the study, and will be be randomized to either the treatment condition or the wait-list control condition. Participants assigned to the wait-list will have the option of receiving the online program once they have completed their commitment to the study (approximately 5 months later). In addition to completing standardized questionnaires, couples will participate in pre- and post-treatment interviews, which will be analyzed thematically in order to improve the intervention and its delivery.
The proposed project builds upon existing research pertaining to the sexual health implications of female cancer survivorship, and will fill a gap both in the literature and support available to breast cancer survivors experiencing sexual distress. Given that sexual distress is such a crucial concern for women with breast cancer, and that the majority of couples experiencing sexual difficulties may not receive adequate support in this regard, the goal of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help improve the quality of life of couples affected by breast cancer.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 36 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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-Patient has received a diagnosis within the last 5 years of invasive breast carcinoma (non- metastatic), or ductal carcinoma in-situ
chemotherapy, radiation, tamoxifen)
Exclusion Criteria:
The intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing.
Behavioral: Psychosexual Intervention
Couples will complete six weekly psychosexual counselling sessions. Each session will focus on areas relevant to sex therapy and sexual dysfunction in couples facing breast cancer (e.g. education, communication, body imagery, sensate focusing, and problem solving). Sessions will be one hour in length (Note: Session 1 will be 1.5 hours), during which couples will meet with a facilitator via videoconferencing.
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
The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Revised Dyadic Adjustment Scale (RDAS)
The RDAS assesses couple's level of relationship satisfaction.
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Maudsley Marital Questionnaire (marital sub-scale only)
The Maudsley Marital Questionnaire assesses martial quality and happiness.
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Profile of Mood States Short Form (POMS-SF)
The POMS-SF assesses overall psychological adjustment.
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Centre for Epidemiological Studies Depression Scale
This measure assesses psychological adjustment, specifically with respect to depressive symptoms.
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Generalized Anxiety Disorder Assessment (GAD-7)
This measure assesses psychological adjustment, specifically with respect to anxiety
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Breast Cancer Prevention Trial Symptom Checklist
The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments.
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Spousal Skills Checklist
The SSC measures partners' perceived support of their female partners
Time frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Program Expectancy Questionnaire
The Program Expectancy Questionnaire will assess participants' expectations for the intervention, including the degree to which they believe the intervention will be effective.
Time frame: Pre-treatment (0 weeks)
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre