Psychosocial in Uterine Cervical Neoplasms and Genital Neoplasms, Female and Ovarian Neoplasms - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- District of Columbia
  - Washington, District of Columbia, United States, 20307
    - Recruiting
    - Walter Reed Army Medical Center
    - Contact:
      
      Karen Livornese, BSN, RN
      
      Phone Number: 202-782-6244
      
      Email: karen.Livornese@amedd.army.mil
    - Contact:
      
      Cynthia A Perry, CIP
      
      Phone Number: (202) 782-8461
      
      Email: cynthia.perry@amedd.army.mil
    - Principal Investigator:
      
      LTC G. Larry Maxwell, MD
- Ohio
  - Columbus, Ohio, United States, 43210
    - Active, not recruiting
    - Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Collaborators

Walter Reed Army Medical Center

Ohio State University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

February 1, 2011

Study Registration Dates

First Submitted

October 23, 2006

First Submitted That Met QC Criteria