An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners (OPIC)
|ClinicalTrials.gov Identifier: NCT01342302|
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : April 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Psychosocial Intervention for Couples||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Single arm study design
Behavioral: Psychosocial Intervention for Couples
Intervention delivered on line
- Change in Dyadic Adjustment Scale (DAS) scores from pre (0 weeks) to post-treatment (7 weeks) [ Time Frame: pre-treatment (0 weeks) and immediate 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) [ Time Frame: pre-treatment (0 weeks) and immediate 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).
- Mental Psychological Development Questionnaire (MPDQ) [ Time Frame: Pre-treatment (0 weeks) and immediate post-treatment (12 weeks). ]The MPDQ assesses individual psychological adjustment.
- Mental Health Inventory (MHI) [ Time Frame: pre-treatment (0 weeks) and post-treatment (7 weeks) ]The MHI assesses individual psychological adjustment.
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks) ]The HADS assesses individual psychological adjustment.
- Functional Assessment of Cancer Therapy-Breast (FACT-B) [ Time Frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks ]The FACT-B assesses women's individual physical and psychological adjustment to breast cancer treatment.
- Breast Cancer and Relationship Measure [ Time Frame: pre-treatment (0 weeks) and immediate post-treatment (7 weeks ]This measure assesses the impact of breast cancer on couple mutuality.
- Treatment Expectancy and Motivation Measure (TEMM) [ Time Frame: pre-treatment (0 weeks) ]The TEMM assesses the degree to which individuals believe that the treatment will be helpful to them prior to starting the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342302
|Sunnybrook Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|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|