An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer (IPSIC)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial|
- 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 [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up ] [ Designated as safety issue: No ]The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.
- Revised Dyadic Adjustment Scale (RDAS) [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up ] [ Designated as safety issue: No ]The RDAS assesses couple's level of relationship satisfaction.
- Maudsley Marital Questionnaire (marital sub-scale only) [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up ] [ Designated as safety issue: No ]The Maudsley Marital Questionnaire assesses martial quality and happiness.
- Profile of Mood States Short Form (POMS-SF) [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up ] [ Designated as safety issue: No ]The POMS-SF assesses overall psychological adjustment.
- Functional Assessment of Cancer Therapy-Breast (FACT-B). [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up ] [ Designated as safety issue: No ]The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.
- Program Expectancy Questionnaire [ Time Frame: Pre-treatment (0 weeks) ] [ Designated as safety issue: No ]The Program Expectancy Questionnaire will assess participants' expectations for the intervention, including the degree to which they believe the intervention will be effective.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Single arm study design
Behavioral: Psychosexual Intervention
Couples will complete in 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.
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.
Twenty-five couples will participate in the intervention, and a repeated measures analysis of covariance will be undertaken to assess the treatment effect over time. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01881022
|Contact: Kimberley Cullen, MA||416-736-2100 ext firstname.lastname@example.org|
|Contact: Karen Fergus, PhD||416-480-5000 ext email@example.com|
|Sunnbrook Odette Cancer Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Kimberley Cullen, MA 416-736-2100 ext 44028 firstname.lastname@example.org|
|Contact: Karen Fergus, PhD 416-480-5000 ext 1243 email@example.com|
|Principal Investigator: Karen Fergus, PhD|
|Principal Investigator:||Karen Fergus, PhD||Sunnybrook Odette Cancer Centre|