Quality of Life in Survivors of Gynecologic Cancer - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003795

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:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066938, GOG-9902
Study First Received:	November 1, 1999
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00003795 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage I endometrial carcinoma
stage II endometrial carcinoma

Additional relevant MeSH terms:

Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Uterine Diseases
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Adnexal Diseases
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms
Neoplasms by Site
Uterine Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009