An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
N/A
80 Years
Both
Breast Cancer
Trial Information
An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
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.
Inclusion Criteria:
- Patient has received a diagnosis within the last 36 months of invasive breast
carcinoma (non-metastatic), or ductal carcinoma in-situ
- Patient has received a mastectomy or lumpectomy and undergone chemotherapy
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome 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
Outcome Description:
The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.
Outcome Time Frame:
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Safety Issue:
No
Principal Investigator
Karen Fergus, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sunnybrook Odette Cancer Centre
Authority:
Canada: Health Canada
Study ID:
CBCF-092013
NCT ID:
NCT01881022
Start Date:
August 2013
Completion Date:
August 2016
Related Keywords:
- Breast Cancer
- Breast Cancer
- Couples
- Sexual Dysfunction
- Psychosexual Intervention
- Sex Therapy
- Online Support
- e-health
- Breast Neoplasms
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