Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01342302
Status:
COMPLETED
Last Update Posted:
2013-04-10
First Post:
2009-10-15
Brief Title:
An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
An Online Psychoeducational Intervention for Young Women With Breast Cancer and Their Partners
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPIC
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 programs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None