- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01881022
An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer (IPSIC)
An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnbrook Odette Cancer Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psychosexual Intervention
The intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
|
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.
|
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
|
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.
|
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
|
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.
|
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
|
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
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pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
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Breast Cancer Prevention Trial Symptom Checklist
Time Frame: pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
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The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments.
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pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
|
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
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pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Pre-treatment (0 weeks)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Karen Fergus, PhD, Toronto Sunnybrook Regional Cancer Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBCF-092013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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