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Sponsors and Collaborators: |
U.S. Army Medical Research and Materiel Command Walter Reed Army Medical Center Ohio State University |
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Information provided by: | Walter Reed Army Medical Center |
ClinicalTrials.gov Identifier: | NCT00391664 |
The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer survivors.
Condition | Intervention |
---|---|
Endometrial Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Genital Neoplasms, Female |
Behavioral: Psychosocial |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Gynecologic Cancer Survivorship Survey |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2011 |
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:
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.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laura Petersen | (614) 292-6874 | peterson.266@osu.edu |
Contact: Carolyn Hagopian | (614) 292-3541 | hagopian.5@osu.edu |
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 cynthia.perry@amedd.army.mil | |
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 |
Study ID Numbers: | 05-44025 |
Study First Received: | October 23, 2006 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00391664 History of Changes |
Health Authority: | United States: Federal Government |
Endometrial cancer Ovarian Cancer Cervical Cancer Genital Cancer |
Vulvar Cancer Vaginal Cancer Other Gynecological Cancers |
Vaginal Neoplasms Ovarian Neoplasms Gonadal Disorders Vulvar Cancer Vaginal Cancer Genital Neoplasms, Female Endocrine System Diseases Uterine Diseases Endometrial Cancer Vaginal Diseases Urogenital Neoplasms |
Ovarian Diseases Uterine Cervical Neoplasms Genital Diseases, Female Endometrial Neoplasms Uterine Cervical Diseases Vulvar Neoplasms Ovarian Cancer Uterine Neoplasms Endocrinopathy Vulvar Diseases Endocrine Gland Neoplasms |
Vaginal Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Uterine Diseases Vaginal Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases |
Uterine Cervical Neoplasms Genital Diseases, Female Neoplasms Endometrial Neoplasms Uterine Cervical Diseases Neoplasms by Site Vulvar Neoplasms Uterine Neoplasms Vulvar Diseases Endocrine Gland Neoplasms |