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Gynecologic Cancer Survivorship Survey


N/A
20 Years
75 Years
Open (Enrolling)
Female
Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Genital Neoplasms, Female

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Trial Information

Gynecologic Cancer Survivorship Survey


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.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Barbara L Andersen, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Ohio State University

Authority:

United States: Federal Government

Study ID:

05-44025

NCT ID:

NCT00391664

Start Date:

February 2006

Completion Date:

February 2011

Related Keywords:

  • Endometrial Neoplasms
  • Ovarian Neoplasms
  • Uterine Cervical Neoplasms
  • Vulvar Neoplasms
  • Vaginal Neoplasms
  • Genital Neoplasms, Female
  • Endometrial cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Genital Cancer
  • Vulvar Cancer
  • Vaginal Cancer
  • Other Gynecological Cancers
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Endometrial Neoplasms
  • Genital Neoplasms, Female
  • Ovarian Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Adenoma

Name

Location

Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Ohio State University Columbus, Ohio  43210