Questionnaire Study for Gynecological Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Walter Reed Army Medical Center
Ohio State University
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00391664
First received: October 23, 2006
Last updated: June 26, 2008
Last verified: June 2008
  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

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

Resource links provided by NLM:


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

No publications provided

ClinicalTrials.gov Identifier: NCT00391664     History of Changes
Other Study ID Numbers: 05-44025
Study First Received: October 23, 2006
Last Updated: June 26, 2008
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

Additional relevant MeSH terms:
Vulvar Neoplasms
Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Genital Neoplasms, Female
Ovarian Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Vaginal Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on April 15, 2014