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Quality of Life in Survivors of Gynecologic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003795
First received: November 1, 1999
Last updated: May 24, 2013
Last verified: March 2009

November 1, 1999
May 24, 2013
April 1999
March 2002   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003795 on ClinicalTrials.gov Archive Site
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Quality of Life in Survivors of Gynecologic Cancer
Quality of Life of Gynecologic Cancer Survivors

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.

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.

Observational
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  • Endometrial Cancer
  • Ovarian Cancer
Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
311
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March 2002   (final data collection date for primary outcome measure)

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
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00003795
CDR0000066938, GOG-9902
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Lari B. Wenzel, PhD Chao Family Comprehensive Cancer Center
Gynecologic Oncology Group
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP