Questionnaire Study for Gynecological Cancer Survivors

NCT ID: NCT00391664

Last Updated: 2008-06-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2011-02-28

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.

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

Study Design

• Study Time Perspective: PROSPECTIVE

Interventions

Psychosocial

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed Army Medical Center

FED

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Principal Investigators

Barbara L Andersen, PhD

Role: STUDY_DIRECTOR

Ohio State University

LTC G. Larry Maxwell, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status: ACTIVE_NOT_RECRUITING

Countries

United States

Central Contacts

Laura Petersen

Role: CONTACT

Phone: (614) 292-6874

Email: peterson.266@osu.edu

Carolyn Hagopian

Role: CONTACT

Phone: (614) 292-3541

Email: hagopian.5@osu.edu

Facility Contacts

Karen Livornese, BSN, RN

Role: primary

Cynthia A Perry, CIP

Role: backup

Other Identifiers

05-44025

Identifier Type: -

Identifier Source: org_study_id