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

NCT ID: NCT01342302

Last Updated: 2013-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Couples Intervention

Single arm study design

Group Type OTHER

Psychosocial Intervention for Couples

Intervention Type BEHAVIORAL

Intervention delivered on line

Interventions

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Psychosocial Intervention for Couples

Intervention delivered on line

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Breast Cancer Foundation

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Karen Fergus

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Fergus, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto Sunnybrook Regional Cancer Centre

Debbie McLeod, PhD, RN

Role: STUDY_DIRECTOR

Cancer Care Program, Nova Scotia Cancer Centre

Ellen Warner, MD

Role: STUDY_DIRECTOR

Toronto Sunnybrook Regional Cancer Centre

Sandra Gardner, PhD

Role: STUDY_DIRECTOR

Toronto Sunnybrook Regional Cancer Centre

Margaret Fitch, RN

Role: STUDY_DIRECTOR

Toronto Sunnybrook Regional Cancer Centre

Barbara Fitzgerald, RN

Role: STUDY_DIRECTOR

Princess Margaret Hospital, Canada

Leeat Granek, PhD

Role: STUDY_DIRECTOR

Toronto Sunnybrook Regional Cancer Centre

Locations

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Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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200-2008

Identifier Type: -

Identifier Source: org_study_id

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