Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391664
Status:
UNKNOWN
Last Update Posted:
2008-06-30
First Post:
2006-10-23
Brief Title:
Questionnaire Study for Gynecological Cancer Survivors
Sponsor:
US Army Medical Research and Development Command
Organization:
Walter Reed Army Medical Center
Study Overview
Official Title:
Gynecologic Cancer Survivorship Survey
Status:
UNKNOWN
Status Verified Date:
2008-06
Last Known Status:
RECRUITING
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 evaluate the quality of life of long-term gynecologic cancer survivors
Detailed Description:
Since the early 1970s death rates for the major gynecological tumors have significantly declined with a reduction of 42 for endometrial 49 for cervix 27 for vagina and vulva and 11 for ovarian cancer Thus of the approximately 82000 new gynecologic cases each year more women will be living and necessarily be forced to cope with psychological or behavioral morbidity Psychosocial data on cancer patients portray significant fear and anxiety with diagnosis and treatments and the potential for high levels of psychological and sexual morbidity While many studies have been done investigating sexual outcomes little data is available on basic domains of quality of life ie emotional or social adjustment occupational outcomes or aspects of physical health that might influence quality of life for gynecologic cancer survivors There is a need for basic descriptive research in these areas particularly in investigations that include representative samples from differing socioeconomic and racialethnic groups
The goal of the proposed study is to evaluate quality of life in long-term gynecologic cancer survivors The specific aims are to
1 Describe quality of life both mental health and physical functioning components stress and sexual functioning among survivors of gynecologic malignancies and
2 Describe differences between disease site groups ie cervical endometrial ovarian and vulva
It has been shown with other cancer groups that improvements in mood and coping can be achieved with brief cost effective interventions eg ten therapy hours with delivery in a group format These are multi-modal interventions with stress reduction diseasetreatment information cognitive behavioral coping strategies and social support There is suggestive evidence that disease specific interventions such as including sexual therapies for gynecologic patients can result in improvements as well Research focus on these issues is aided by the availability of reliable and valid strategies to assess both quality of life SF-36 FACT and sexuality Before clinical trials are undertaken research must provide a comprehensive assessment of quality of life for gynecologic cancer survivors
The goal of the proposed study is to evaluate quality of life in long-term gynecologic cancer survivors The specific aims are to
1 Describe quality of life both mental health and physical functioning components stress and sexual functioning among survivors of gynecologic malignancies and
2 Describe differences between disease site groups ie cervical endometrial ovarian and vulva
It has been shown with other cancer groups that improvements in mood and coping can be achieved with brief cost effective interventions eg ten therapy hours with delivery in a group format These are multi-modal interventions with stress reduction diseasetreatment information cognitive behavioral coping strategies and social support There is suggestive evidence that disease specific interventions such as including sexual therapies for gynecologic patients can result in improvements as well Research focus on these issues is aided by the availability of reliable and valid strategies to assess both quality of life SF-36 FACT and sexuality Before clinical trials are undertaken research must provide a comprehensive assessment of quality of life for gynecologic cancer survivors
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