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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01881022
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : February 25, 2019
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Karen Fergus, Sunnybrook Health Sciences Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Behavioral: Psychosexual Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group 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
Actual Study Start Date : June 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01881022

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Canada, Ontario
Sunnbrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Breast Cancer Foundation
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Principal Investigator: Karen Fergus, PhD Toronto Sunnybrook Regional Cancer Centre

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Responsible Party: Karen Fergus, Principal Investigator, Sunnybrook Health Sciences Centre Identifier: NCT01881022     History of Changes
Other Study ID Numbers: CBCF-092013
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Keywords provided by Karen Fergus, Sunnybrook Health Sciences Centre:
Breast Cancer
Sexual Dysfunction
Psychosexual Intervention
Sex Therapy
Online Support
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases