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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Psychosexual Intervention
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Couples, Sexual Dysfunction, Psychosexual Intervention, Sex Therapy, Online Support, e-health

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sunnbrook Odette Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychosexual Intervention

Arm Description

The intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing.

Outcomes

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
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)
The RDAS assesses couple's level of relationship satisfaction.
Maudsley Marital Questionnaire (marital sub-scale only)
The Maudsley Marital Questionnaire assesses martial quality and happiness.
Profile of Mood States Short Form (POMS-SF)
The POMS-SF assesses overall psychological adjustment.
Centre for Epidemiological Studies Depression Scale
This measure assesses psychological adjustment, specifically with respect to depressive symptoms.
Generalized Anxiety Disorder Assessment (GAD-7)
This measure assesses psychological adjustment, specifically with respect to anxiety
Breast Cancer Prevention Trial Symptom Checklist
The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments.
Spousal Skills Checklist
The SSC measures partners' perceived support of their female partners

Full Information

First Posted
June 14, 2013
Last Updated
February 21, 2019
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01881022
Brief Title
An Internet-based Psychosexual Intervention for Couples Following Treatment for Breast Cancer
Acronym
IPSIC
Official Title
An Evaluation of an Internet-based, Psychosexual Intervention for Couples Following Treatment for Breast Cancer: A Phase I Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Couples, Sexual Dysfunction, Psychosexual Intervention, Sex Therapy, Online Support, e-health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychosexual Intervention
Arm Type
Experimental
Arm Description
The intervention will consist of 6 weekly sessions of couples psychosexual counseling delivered via videoconferencing.
Intervention Type
Behavioral
Intervention Name(s)
Psychosexual Intervention
Intervention Description
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 Measure Information:
Title
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
Description
The SFQ assesses couples' sexual satisfaction and functioning. The SFQ will be used to assess change in couples' level of sexual functioning.
Time Frame
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Secondary Outcome Measure Information:
Title
Revised Dyadic Adjustment Scale (RDAS)
Description
The RDAS assesses couple's level of relationship satisfaction.
Time Frame
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Title
Maudsley Marital Questionnaire (marital sub-scale only)
Description
The Maudsley Marital Questionnaire assesses martial quality and happiness.
Time Frame
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and 3 month follow-up
Title
Profile of Mood States Short Form (POMS-SF)
Description
The POMS-SF assesses overall psychological adjustment.
Time Frame
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Title
Centre for Epidemiological Studies Depression Scale
Description
This measure assesses psychological adjustment, specifically with respect to depressive symptoms.
Time Frame
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Title
Generalized Anxiety Disorder Assessment (GAD-7)
Description
This measure assesses psychological adjustment, specifically with respect to anxiety
Time Frame
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Title
Breast Cancer Prevention Trial Symptom Checklist
Description
The BCPT measures commonly reported physical and psychological symptoms associated with breast cancer and associated treatments.
Time Frame
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Title
Spousal Skills Checklist
Description
The SSC measures partners' perceived support of their female partners
Time Frame
pre-treatment (0 weeks), immediate post-treatment (6 weeks), and three months follow-up
Other Pre-specified Outcome Measures:
Title
Program Expectancy Questionnaire
Description
The Program Expectancy Questionnaire will assess participants' expectations for the intervention, including the degree to which they believe the intervention will be effective.
Time Frame
Pre-treatment (0 weeks)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Fergus, PhD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnbrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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

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