An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer (IPSIC)
|ClinicalTrials.gov Identifier: NCT01881022|
Recruitment Status : Unknown
Verified June 2015 by Karen Fergus, Sunnybrook Health Sciences Centre.
Recruitment status was: Recruiting
First Posted : June 19, 2013
Last Update Posted : June 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Psychosexual Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
Experimental: Psychosexual Intervention
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.
No Intervention: Wait-list Control
Participants in the wait-list control will not receive the intervention.
- 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 ]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 ]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 ]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 ]The POMS-SF assesses overall psychological adjustment.
- Centre for Epidemiological Studies Depression Scale [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up ]This measure assesses psychological adjustment, specifically with respect to depressive symptoms.
- Generalized Anxiety Disorder Assessment (GAD-7) [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up ]This measure assesses psychological adjustment, specifically with respect to anxiety
- Breast Cancer Prevention Trial Symptom Checklist [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up ]The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments.
- Spousal Skills Checklist [ Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up ]The SSC measures partners' perceived support of their female partners
- Program Expectancy Questionnaire [ Time Frame: Pre-treatment (0 weeks) ]The Program Expectancy Questionnaire will assess participants' expectations for the intervention, including the degree to which they believe the intervention will be effective.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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||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||Toronto Sunnybrook Regional Cancer Centre|