An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer (IPSIC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Karen Fergus, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01881022
First received: June 14, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Psychosexual Intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
Psychosexual Intervention
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.

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.

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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881022

Contacts
Contact: Kimberley Cullen, MA 416-736-2100 ext 44028 kacullen@yorku.ca
Contact: Karen Fergus, PhD 416-480-5000 ext 1243 karen.fergus@sunnybrook.ca

Locations
Canada, Ontario
Sunnbrook Odette Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Kimberley Cullen, MA    416-736-2100 ext 44028    kacullen@yorku.ca   
Contact: Karen Fergus, PhD    416-480-5000 ext 1243    karen.fergus@sunnybrook.ca   
Principal Investigator: Karen Fergus, PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Karen Fergus, PhD Sunnybrook Odette Cancer Centre
  More Information

No publications provided

Responsible Party: Karen Fergus, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01881022     History of Changes
Other Study ID Numbers: CBCF-092013
Study First Received: June 14, 2013
Last Updated: June 14, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Breast Cancer
Couples
Sexual Dysfunction
Psychosexual Intervention
Sex Therapy
Online Support
e-health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014