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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Psychosocial Intervention for Couples
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, Distress, Online Support, e-health, Intervention, Relationships

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sunnybrook Odette Cancer Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Couples Intervention

Arm Description

Single arm study design

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Mental Psychological Development Questionnaire (MPDQ)
The MPDQ assesses individual psychological adjustment.
Mental Health Inventory (MHI)
The MHI assesses individual psychological adjustment.
Hospital Anxiety and Depression Scale (HADS)
The HADS assesses individual psychological adjustment.
Functional Assessment of Cancer Therapy-Breast (FACT-B)
The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.
Breast Cancer and Relationship Measure
This measure assesses the impact of breast cancer on couple mutuality.
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.

Full Information

First Posted
October 15, 2009
Last Updated
April 9, 2013
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01342302
Brief Title
An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
Acronym
OPIC
Official Title
An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (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
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
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.

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, Distress, Online Support, e-health, Intervention, Relationships

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
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Couples Intervention
Arm Type
Other
Arm Description
Single arm study design
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Intervention for Couples
Intervention Description
Intervention delivered on line
Primary Outcome Measure Information:
Title
Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)
Description
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).
Time Frame
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Title
Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks)
Description
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).
Time Frame
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Secondary Outcome Measure Information:
Title
Mental Psychological Development Questionnaire (MPDQ)
Description
The MPDQ assesses individual psychological adjustment.
Time Frame
Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
Title
Mental Health Inventory (MHI)
Description
The MHI assesses individual psychological adjustment.
Time Frame
pre-treatment (0 weeks) and post-treatment (7 weeks)
Title
Hospital Anxiety and Depression Scale (HADS)
Description
The HADS assesses individual psychological adjustment.
Time Frame
pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Title
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Description
The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.
Time Frame
pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Title
Breast Cancer and Relationship Measure
Description
This measure assesses the impact of breast cancer on couple mutuality.
Time Frame
pre-treatment (0 weeks) and immediate post-treatment (7 weeks
Title
Treatment Expectancy and Motivation Measure (TEMM)
Description
The TEMM assesses the degree to which individuals believe that the treatment will be helpful to them prior to starting the treatment.
Time Frame
pre-treatment (0 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
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
First Name & Middle Initial & Last Name & Degree
Debbie McLeod, PhD, RN
Organizational Affiliation
Cancer Care Program, Nova Scotia Cancer Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ellen Warner, MD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sandra Gardner, PhD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Margaret Fitch, RN
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Barbara Fitzgerald, RN
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Leeat Granek, PhD
Organizational Affiliation
Toronto Sunnybrook Regional Cancer Centre
Official's Role
Study Director
Facility Information:
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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

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