Clinical trial NCT00391664: Questionnaire Study for Gynecological Cancer Survivors
Official title: Gynecologic Cancer Survivorship Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Genital Neoplasms, Female
Keywords: Endometrial cancer
Ovarian Cancer
Cervical Cancer
Genital Cancer
Vulvar Cancer
Vaginal Cancer
Other Gynecological Cancers
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
Collaborators: name: Walter Reed Army Medical Center
name: Ohio State University
First posted: 2006-10-24
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Barbara L Andersen, PhD
role: STUDY_DIRECTOR
affiliation: Walter Reed Army Medical Center
name: LTC G. Larry Maxwell, MD
role: PRINCIPAL_INVESTIGATOR
References: