An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners (OPIC)

This study has been completed.
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Karen Fergus, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01342302
First received: October 15, 2009
Last updated: April 9, 2013
Last verified: April 2011
  Purpose

Breast cancer is distressing for couples in general but even more so when the illness strikes at a relatively young age. In addition to common relationship challenges, younger couples have to contend with the loss or disruption of age-appropriate goals for themselves. Presently, there are virtually no resources designed specifically to assist young couples coping with breast cancer. The purpose of this study is to develop and evaluate an online educational program geared to the unique needs and demanding schedules of young couples. The purpose of the program is to improve couples' relationships and mutual coping. Seventeen couples will take part in the 7-week program. They will complete questionnaires before and after participating to evaluate the program's helpfulness. This study will allow for the creation of a user-friendly, cost-effective tool that could help to improve the lives of all young couples coping with breast cancer in the years to come.


Condition Intervention
Breast Cancer
Behavioral: Psychosocial Intervention for Couples

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks) [ Time Frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks) ] [ Designated as safety issue: No ]
    The DAS assesses couple's level of relationship satisfaction. The DAS will be used to assess change in couples' level of relationship satisfaction following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).

  • Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks) [ Time Frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks) ] [ Designated as safety issue: No ]
    The Personal Assessment of Intimacy in Relationships scale assesses the degree of feelings of intimacy between partners. This primary outcome measure will be used to assess changes in the degree of the feelings of intimacy between partners following participation in the Couplelinks program over a 7 week period, from pre-treatment (0 weeks) to post-treatment (7 weeks).


Secondary Outcome Measures:
  • Mental Psychological Development Questionnaire (MPDQ) [ Time Frame: Pre-treatment (0 weeks) and immediate post-treatment (12 weeks). ] [ Designated as safety issue: No ]
    The MPDQ assesses individual psychological adjustment.

  • Mental Health Inventory (MHI) [ Time Frame: pre-treatment (0 weeks) and post-treatment (7 weeks) ] [ Designated as safety issue: No ]
    The MHI assesses individual psychological adjustment.

  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks) ] [ Designated as safety issue: No ]
    The HADS assesses individual psychological adjustment.

  • Functional Assessment of Cancer Therapy-Breast (FACT-B) [ Time Frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks ] [ Designated as safety issue: No ]
    The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.

  • Breast Cancer and Relationship Measure [ Time Frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks ] [ Designated as safety issue: No ]
    This measure assesses the impact of breast cancer on couple mutuality.

  • Treatment Expectancy and Motivation Measure (TEMM) [ Time Frame: pre-treatment (0 weeks) ] [ Designated as safety issue: No ]
    The TEMM assesses the degree to which individuals believe that the treatment will be helpful to them prior to starting the treatment.


Enrollment: 20
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Couples Intervention
Single arm study design
Behavioral: Psychosocial Intervention for Couples
Intervention delivered on line

Detailed Description:

Women diagnosed with breast cancer at or before the age of 40 experience greater distress and poorer quality of life than women diagnosed later in life. In addition to having to cope with the range of issues common to all women with breast cancer, young women face unique challenges such as loss of fertility, concerns for young children, and interruptions to early-stage careers. The presence of adequate social support is a mitigating factor for distress in young women, and spousal support in particular has been shown to play a crucial and distinctive role in determining how well a woman adjusts to breast cancer. Unfortunately, the evidence suggests well-spouses are significantly distressed themselves, and often fall short in their attempts to meet the needs of their ill partners despite generally good intentions. Consequently, researchers have recommended that psychosocial interventions be geared to couples. However, traditional counseling interventions may not appeal to younger couples with numerous responsibilities and time constraints.

The purpose of this study is to examine the feasibility, process, and outcomes of an innovative online intervention tailored to the unique needs of young women and their partners. The primary goal is to improve partners' relationship functioning and capacity to work together as a team in relation to the illness. The secondary goal is to combat feelings of isolation by creating a community of similarly affected couples. The intervention will be delivered via a professionally moderated, password-protected website and entail: Information relevant to young couples with breast cancer; structured, interactive learning modules; and a discussion board. The online modality is particularly suited to the younger demographic targeted by this project because of its familiarity, comfort, convenience, and flexibility.

A non-randomized, repeated measures analysis of variance design will be used to test the intervention. Seventeen couples will be recruited within the Greater Toronto Area. Questionnaires assessing relationship functioning, psychological adjustment, and quality of life will be administered to participants at baseline and at completion of the 7-week program. Qualitative data from the website and treatment satisfaction questionnaire will be analyzed thematically in order to improve the intervention and its delivery.

The potential for this online intervention to fill a void in support options available to both young women with breast cancer and their partners is vast. Following completion of the project, not only will there be a demonstrable product in the website, but the investigators will have the knowledge with which to further test the intervention in a RCT. The ultimate impact of the proposed project will be the creation of an accessible, cost-effective, empirically validated tool that could help to improve the quality of life of all young couples coping with breast cancer, regardless of geographic location, in the years to come.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • woman has received a diagnosis of breast carcinoma within the last 18 months at any point in her treatment trajectory.
  • Women must be free of known local recurrence or metastatic disease at the time of enrolment.
  • Patients will have been 40 years of age or younger when diagnosed.
  • Partners must be 45 years of age or younger at the time of diagnosis. - Couples must be heterosexual, and married, cohabitating, or engaged. - Participants must be fluent in English with the ability to read and write in English.
  • All participants will require convenient access to a computer with internet connection.

Exclusion Criteria:

  • All participants will be screened for mental illness that would interfere with their capacity to benefit from the program (e.g., suicidality, psychotic disorders, substance abuse) and excluded on this basis.
  • Couples who plan to participate in couple or individual counselling during the 7-week study duration will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342302

Locations
Canada, Ontario
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Breast Cancer Foundation
Investigators
Principal Investigator: Karen Fergus, PhD Sunnybrook Odette Cancer Centre
Study Director: Debbie McLeod, PhD, RN Cancer Care Program, Nova Scotia Cancer Centre
Study Director: Ellen Warner, MD Sunnybrook Odette Cancer Centre
Study Director: Sandra Gardner, PhD Sunnybrook Odette Cancer Centre
Study Director: Margaret Fitch, RN Sunnybrook Odette Cancer Centre
Study Director: Barbara Fitzgerald, RN Princess Margaret Hospital, Canada
Study Director: Leeat Granek, PhD Sunnybrook Odette Cancer Centre
  More Information

No publications provided

Responsible Party: Karen Fergus, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01342302     History of Changes
Other Study ID Numbers: 200-2008
Study First Received: October 15, 2009
Last Updated: April 9, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Breast Cancer
Couples
Distress
Online Support
e-health
Intervention
Relationships

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

ClinicalTrials.gov processed this record on April 17, 2014