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Quality of Life in Survivors of Gynecologic Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003795
First Posted: July 18, 2003
Last Update Posted: May 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group
  Purpose

RATIONALE: Quality-of-life assessment in cancer survivors may help determine the long-term effects of having had gynecologic cancer and may help improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is studying the quality of life in survivors of gynecologic cancer.


Condition Intervention
Endometrial Cancer Ovarian Cancer Procedure: quality-of-life assessment

Study Type: Observational
Official Title: Quality of Life of Gynecologic Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 311
Study Start Date: April 1999
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Describe the significant quality of life (QOL) concerns and long term survivorship issues of women diagnosed and treated for early stage ovarian and endometrial cancer five or more years ago.
  • Identify mechanisms which contribute to a gynecologic cancer survivorship model through comparison and prediction of high versus low QOL associated with long term adjustment and survivorship. Examine social support, coping efforts, self-efficacy, meaning associated with survivorship, performance status, and age at diagnosis as potential predictors.
  • Identify and compare factors that predict high versus low QOL for women with early stage endometrial cancer completing participation in GOG-99 clinical trial. Conduct exploratory analysis examining long term QOL concerns of survivors randomized to surgery arm with or without radiotherapy.

OUTLINE: Patients complete one telephone interview with a professional female interviewer. The interview lasts approximately 60 minutes and is audiotaped.

PROJECTED ACCRUAL: A total of 197 early stage endometrial cancer survivors and 114 early stage ovarian cancer survivors will be accrued for this study within 2 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed early stage ovarian and endometrial cancer survivors treated and diagnosed five or more years ago
  • Patients completing treatment in GOG-95 or GOG-99 protocols at least 5 years ago with no recurrence of disease
  • Patients with secondary malignancy or under treatment for other medical conditions are eligible

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Must be capable of completing telephone interview in English

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003795


  Show 44 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Lari B. Wenzel, PhD Chao Family Comprehensive Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00003795     History of Changes
Other Study ID Numbers: CDR0000066938
GOG-9902
First Submitted: November 1, 1999
First Posted: July 18, 2003
Last Update Posted: May 27, 2013
Last Verified: March 2009

Keywords provided by Gynecologic Oncology Group:
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage I endometrial carcinoma
stage II endometrial carcinoma

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female