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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Psychosocial Intervention for Couples

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Couples Intervention; Single arm study design	Behavioral: Psychosocial Intervention for Couples; Intervention delivered on line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)	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).	pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks)	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).	pre-treatment (0 weeks) and immediate post-treatment (7 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Psychological Development Questionnaire (MPDQ)	The MPDQ assesses individual psychological adjustment.	Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
Mental Health Inventory (MHI)	The MHI assesses individual psychological adjustment.	pre-treatment (0 weeks) and post-treatment (7 weeks)
Hospital Anxiety and Depression Scale (HADS)	The HADS assesses individual psychological adjustment.	pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Functional Assessment of Cancer Therapy-Breast (FACT-B)	The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.	pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Breast Cancer and Relationship Measure	This measure assesses the impact of breast cancer on couple mutuality.	pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Treatment Expectancy and Motivation Measure (TEMM)	The TEMM assesses the degree to which individuals believe that the treatment will be helpful to them prior to starting the treatment.	pre-treatment (0 weeks)

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Breast Cancer Foundation
• Investigators: Principal Investigator: Karen Fergus, PhD, Toronto Sunnybrook Regional Cancer Centre; Study Director: Debbie McLeod, PhD, RN, Cancer Care Program, Nova Scotia Cancer Centre; Study Director: Ellen Warner, MD, Toronto Sunnybrook Regional Cancer Centre; Study Director: Sandra Gardner, PhD, Toronto Sunnybrook Regional Cancer Centre; Study Director: Margaret Fitch, RN, Toronto Sunnybrook Regional Cancer Centre; Study Director: Barbara Fitzgerald, RN, Princess Margaret Hospital, Canada; Study Director: Leeat Granek, PhD, Toronto Sunnybrook Regional Cancer Centre

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (Estimate): April 27, 2011

Study Record Updates

• Last Update Posted (Estimate): April 10, 2013
• Last Update Submitted That Met QC Criteria: April 9, 2013
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Breast Cancer; Intervention; e-health; Distress; Couples; Relationships; Online Support
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 200-2008