Clinical trial NCT01342302: An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
Official title: An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Couples
Distress
Online Support
e-health
Intervention
Relationships
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2011-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks)
timeFrame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
measure: Change in Personal Assessment of Intimacy in Relationships scale scores from pre (0 weeks) to post-treatment (7 weeks)
timeFrame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
Secondary outcomes:
measure: Mental Psychological Development Questionnaire (MPDQ)
timeFrame: Pre-treatment (0 weeks) and immediate post-treatment (12 weeks).
measure: Mental Health Inventory (MHI)
timeFrame: pre-treatment (0 weeks) and post-treatment (7 weeks)
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks)
measure: Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
measure: Breast Cancer and Relationship Measure
timeFrame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks
measure: Treatment Expectancy and Motivation Measure (TEMM)
timeFrame: pre-treatment (0 weeks)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Karen Fergus, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Care Program, Nova Scotia Cancer Centre
name: Debbie McLeod, PhD, RN
role: STUDY_DIRECTOR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Ellen Warner, MD
role: STUDY_DIRECTOR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Sandra Gardner, PhD
role: STUDY_DIRECTOR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Margaret Fitch, RN
role: STUDY_DIRECTOR
affiliation: Princess Margaret Hospital, Canada
name: Barbara Fitzgerald, RN
role: STUDY_DIRECTOR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Leeat Granek, PhD
role: STUDY_DIRECTOR
References: