An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
NCT ID: NCT01342302
Last Updated: 2013-04-10
Study Results
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2008-09-30
2011-07-31
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Couples Intervention
Single arm study design
Psychosocial Intervention for Couples
Intervention delivered on line
Interventions
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Psychosocial Intervention for Couples
Intervention delivered on line
Eligibility Criteria
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Inclusion Criteria
* 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
* Couples who plan to participate in couple or individual counselling during the 7-week study duration will be excluded.
20 Years
45 Years
ALL
Yes
Sponsors
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Canadian Breast Cancer Foundation
OTHER
Sunnybrook Health Sciences Centre
OTHER
Responsible Party
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Karen Fergus
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
Countries
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Other Identifiers
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200-2008
Identifier Type: -
Identifier Source: org_study_id
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