Questionnaire Study for Gynecological Cancer Survivors

Sponsor

U.S. Army Medical Research and Development Command (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT00391664

Collaborator

Walter Reed Army Medical Center (U.S. Fed), Ohio State University (Other)

1,000

Enrollment

Locations

Duration (Months)

500

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer survivors.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Neoplasms Ovarian Neoplasms Uterine Cervical Neoplasms Vulvar Neoplasms Vaginal Neoplasms Genital Neoplasms, Female	Behavioral: Psychosocial

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:

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Time Perspective:

Prospective

Official Title:

Gynecologic Cancer Survivorship Survey

Study Start Date :

Feb 1, 2006

Study Completion Date :

Feb 1, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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