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Questionnaire Study for Gynecological Cancer Survivors

This study is currently recruiting participants.
Verified by Walter Reed Army Medical Center, June 2008

Sponsors and Collaborators: U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
Ohio State University
Information provided by: Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00391664
  Purpose

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

MedlinePlus related topics:   Cancer    Cervical Cancer    Ovarian Cancer    Vaginal Cancer    Vulvar Cancer   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Gynecologic Cancer Survivorship Survey

Further study details as provided by Walter Reed Army Medical Center:

Estimated Enrollment:   1000
Study Start Date:   February 2006
Estimated Study Completion Date:   February 2011

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 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:

  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 (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.

  Eligibility
Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Female participants diagnosed with gynecologic cancer
  • Participants between the ages of 20 and 75 years old, inclusive
  • Participants previously treated for all stages (I-IV) of the following cancers: cervix; endometrium; ovary; vulva; vagina; and other genital cancers
  • Participants receiving treatment for their primary cancer in the past 2-10 years

Exclusion Criteria:

  • Male participants
  • Participants with major psychoses (e.g. organic brain syndrome; schizophrenia; bipolar disorder; or mental retardation).
  • Participants with significant hearing deficit
  • Participants with prior non-gynecologic cancer diagnosis
  • Participants who refused all forms of cancer treatment, whether standard of care or experimental.
  • Participants with deficient ability to read/speak English
  • Participants residing >90 miles from the research site
  • Participants diagnosed with dementia
  • Participants diagnosed with pregnancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391664

Contacts
Contact: Laura Petersen     (614) 292-6874     peterson.266@osu.edu    
Contact: Carolyn Hagopian     (614) 292-3541     hagopian.5@osu.edu    

Locations
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

Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
Ohio State University

Investigators
Study Director:     Barbara L Andersen, PhD     Ohio State University    
Principal Investigator:     LTC G. Larry Maxwell, MD     Walter Reed Army Medical Center    
  More Information

Study ID Numbers:   05-44025
First Received:   October 23, 2006
Last Updated:   June 26, 2008
ClinicalTrials.gov Identifier:   NCT00391664
Health Authority:   United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
Endometrial cancer  
Ovarian Cancer  
Cervical Cancer  
Genital Cancer  
Vulvar Cancer
Vaginal Cancer
Other Gynecological Cancers

Study placed in the following topic categories:
Ovarian cancer
Vaginal Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Vaginal cancer
Endocrine System Diseases
Uterine Diseases
Vaginal Diseases
Urogenital Neoplasms
Ovarian Diseases
Uterine Cervical Neoplasms
Genital Diseases, Female
Endometrial Neoplasms
Uterine Cervical Diseases
Vulvar Neoplasms
Uterine Neoplasms
Endocrinopathy
Endometrial cancer
Vulvar Diseases
Vulvar cancer
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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