M. D. Anderson Symptom Inventory - Ovarian Cancer

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Objectives:

The objective of this study is to delineate and measure the symptom burden experienced by patients with ovarian cancer.

The Primary Aim is to develop and validate an ovarian-cancer module of the M. D. Anderson Symptom Inventory (MDASI-Ovarian Cancer) to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients with ovarian cancers.

The Secondary Aims are:

To develop a detailed description of symptom severity and interference with daily activities experienced by patients with ovarian cancer; To assess the impact of symptom severity on standard functioning and quality of life (QOL) measures, including Eastern Cooperative Oncology Group Performance Status (ECOG PS), Functional Assessment of Cancer Therapy-Ovary (FACT-O), and a single-item QOL scale, in patients with ovarian cancer; To define the qualitative symptom burden of patients with ovarian cancer receiving various treatments.

Condition or disease	Intervention/treatment
Ovarian Cancer	Behavioral: Interview; Behavioral: Survey

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Study Design

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Study Type :	Observational
Estimated Enrollment :	158 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer
Actual Study Start Date :	December 2009
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Interview + Questionnaires; 1-on-1 interview + Questionnaires, Part 1 of Study	Behavioral: Interview; 1-on-1 interview with study doctor or staff member, during regularly scheduled, standard of care clinic visit taking 30 minutes. Behavioral: Survey; Complete 3 Questionnaires during clinic visit, about 10 minutes to complete all.; Other Name: Questionnaire
Questionnaires; Questionnaires Only, Part 2 of Study	Behavioral: Survey; Complete 3 Questionnaires during clinic visit, about 10 minutes to complete all.; Other Name: Questionnaire

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Validate ovarian-cancer module of MDASI-Ovarian Cancer to measure severity of multiple symptoms + impact of these symptoms on daily functioning in patients with ovarian cancers. [ Time Frame: Baseline to 2 years (Patient participation done after completing Interview and Surveys during single clinic visit) ]

Secondary Outcome Measures :

1. Patient Rated Symptom Severity and Interference with Function (Survey Response) [ Time Frame: Baseline to 2 years ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

UT MD Anderson Cancer Center ovarian cancer patients, females over the age of 18 years.

Criteria

Inclusion Criteria:

1. Female patients 18 years of age or older.
2. Able to speak and read English.
3. Having a diagnosis of high grade invasive epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer confirmed by pathological analysis.
4. Being followed at M D Anderson Cancer Center and Lyndon B. Johnson General Hospital (LBJ Hospital).
5. Has consented to participate.
6. Has not received any current cancer treatment or prior chemotherapy in the last 30 days (phase 2 subset of 40 patients only)

Exclusion Criteria:

1) Having a medical condition or impaired performance status that would preclude participation in the study.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Texas
Lyndon B. Johnson General Hospital
Houston, Texas, United States, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genentech, Inc.

Investigators

Principal Investigator:	Diane C. Bodurka, MD, BS	M.D. Anderson Cancer Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01037751 History of Changes
Other Study ID Numbers:	2009-0506
First Posted:	December 23, 2009
Last Update Posted:	April 24, 2017
Last Verified:	April 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by M.D. Anderson Cancer Center:

Cancer; Symptom burden; M. D. Anderson Symptom Inventory; MDASI-Ovarian Cancer; Symptoms	Daily functioning; Symptom severity; Questionnaire; Interview

Additional relevant MeSH terms:

Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases	Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders