Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418444
Status:
COMPLETED
Last Update Posted:
2015-07-02
First Post:
2007-01-02
Brief Title:
Body Image and Psychosocial Functioning in Women With Breast Cancer Can We Fix What Weve Broken
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Randomized Control Trial of a Group Therapy Intervention Addressing Body Image and Psychosocial Functioning for Women With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-01
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:
None
Brief Summary:
The purpose of this study is to test an innovative intervention geared towards issues of identity body image and sexuality and to examine the intervention for its impact on body image quality of life psychosocialsexualityrelational functioning
Detailed Description:
Breast cancer is the most frequently diagnosed cancer in women with 1 in 10 Canadian women being diagnosed in their lifetime There has been an increase in the number of survivors due to advances in treatment and early detection and increased scientific attention has been focused on patients quality of life during and after treatment The majority of survivors do well after the initial adjustment within the first 2 years post-treatment However depending on when assessed after treatment completion a wide range of cancer survivors either score at levels suggestive of a psychiatric diagnosis or are diagnosed with a psychological problem Furthermore a subset of survivors experience adjustment problems long after treatment completion Approximately 20 to 40 of survivors develop sexual and body image problems following breast cancer and treatment and these difficulties tend to persist several years after treatment completion
This study aims to test an innovative intervention geared towards issues of identity body image and sexuality and to examine the intervention for its impact on body image and quality of life psychosocial and sexual functioning and relational functioning
One hundred and eighty women who have completed treatment for breast cancer will be randomized into either intervention an 8 weekly psychosocial group support or control condition standard care written educational material All subjects will be followed for 1 year post-intervention It is hypothesized that compared to control subjects who receive standard care and educational materials subjects participating in an 8 weekly psychosocial group support will have higher levels of relationship supportfunctioning and that the group differences will be maintained over the 1-year follow up period
This study aims to test an innovative intervention geared towards issues of identity body image and sexuality and to examine the intervention for its impact on body image and quality of life psychosocial and sexual functioning and relational functioning
One hundred and eighty women who have completed treatment for breast cancer will be randomized into either intervention an 8 weekly psychosocial group support or control condition standard care written educational material All subjects will be followed for 1 year post-intervention It is hypothesized that compared to control subjects who receive standard care and educational materials subjects participating in an 8 weekly psychosocial group support will have higher levels of relationship supportfunctioning and that the group differences will be maintained over the 1-year follow up period
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