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Trial Title:
Questionnaire Study for Gynecological Cancer Survivors
NCT ID:
NCT00391664
Condition:
Endometrial Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Genital Neoplasms, Female
Conditions: Official terms:
Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Genital Neoplasms, Female
Vulvar Neoplasms
Vaginal Neoplasms
Conditions: Keywords:
Endometrial cancer
Ovarian Cancer
Cervical Cancer
Genital Cancer
Vulvar Cancer
Vaginal Cancer
Other Gynecological Cancers
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Psychosocial
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.
Criteria for 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
Gender:
Female
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Walter Reed Army Medical Center
Address:
City:
Washington
Zip:
20307
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen Livornese, BSN, RN
Phone:
202-782-6244
Email:
karen.Livornese@amedd.army.mil
Contact backup:
Last name:
Cynthia A Perry, CIP
Phone:
(202) 782-8461
Email:
cynthia.perry@amedd.army.mil
Investigator:
Last name:
LTC G. Larry Maxwell, MD
Email:
Principal Investigator
Facility:
Name:
Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Active, not recruiting
Start date:
February 2006
Completion date:
February 2011
Lead sponsor:
Agency:
U.S. Army Medical Research and Development Command
Agency class:
U.S. Fed
Collaborator:
Agency:
Walter Reed Army Medical Center
Agency class:
U.S. Fed
Collaborator:
Agency:
Ohio State University
Agency class:
Other
Source:
Walter Reed Army Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00391664