Completed

Quality of Life of Gynecologic Cancer Survivors

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What is being collected

Procedure Data

Procedure
Who is being recruted

Urogenital Diseases+19

+ Genital Diseases

+ Adnexal Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: April 1999
See protocol details

Summary

Principal SponsorGynecologic Oncology Group
Last updated: May 27, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003795
Principal SponsorGynecologic Oncology Group
Last updated: May 27, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

311 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOvarian DiseasesUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital DiseasesCarcinoma, Ovarian EpithelialOvarian NeoplasmsEndometrial Neoplasms

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 44 locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, United States

Community Hospital of Los Gatos

Los Gatos, United States

Chao Family Comprehensive Cancer Center

Orange, United States
Completed44 Study Centers