Questionnaire Study for Gynecological Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00391664|
Recruitment Status : Unknown
Verified June 2008 by Walter Reed Army Medical Center.
Recruitment status was: Recruiting
First Posted : October 24, 2006
Last Update Posted : June 30, 2008
|Condition or disease||Intervention/treatment|
|Endometrial Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Genital Neoplasms, Female||Behavioral: Psychosocial|
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 82,000 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, i.e. 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 racial/ethnic groups.
The goal of the proposed study is to evaluate quality of life in long-term gynecologic cancer survivors. The specific aims are to:
- Describe quality of life (both mental health and physical functioning components), stress, and sexual functioning among survivors of gynecologic malignancies and
- Describe differences between disease site groups (i.e. 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 (e.g. ten therapy hours with delivery in a group format). These are multi-modal interventions with stress reduction, disease/treatment 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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Gynecologic Cancer Survivorship Survey|
|Study Start Date :||February 2006|
|Study Completion Date :||February 2011|
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): NCT00391664
|Contact: Laura Petersen||(614) firstname.lastname@example.org|
|Contact: Carolyn Hagopian||(614) email@example.com|
|United States, District of Columbia|
|Walter Reed Army Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20307|
|Contact: Karen Livornese, BSN, RN 202-782-6244 karen.Livornese@amedd.army.mil|
|Contact: Cynthia A Perry, CIP (202) 782-8461 firstname.lastname@example.org|
|Principal Investigator: LTC G. Larry Maxwell, MD|
|United States, Ohio|
|Ohio State University||Active, not recruiting|
|Columbus, Ohio, United States, 43210|
|Study Director:||Barbara L Andersen, PhD||Ohio State University|
|Principal Investigator:||LTC G. Larry Maxwell, MD||Walter Reed Army Medical Center|