M. D. Anderson Symptom Inventory - Ovarian Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Genentech
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01037751

Purpose

The goal of this behavioral research study is to learn more about the kind of symptoms that are experienced by women with ovarian cancer, peritoneal cancer, or fallopian tube cancer.

Condition	Intervention
Ovarian Cancer	Behavioral: Interview Behavioral: Survey

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Rated Symptom Severity and Interference with Function (Survey Response) [ Time Frame: Baseline to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	143
Study Start Date:	December 2009
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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:

Female patients 18 years of age or older.
Able to speak and read English.
Having a diagnosis of high grade invasive epithelial ovarian cancer, peritoneal cancer or fallopian tube cancer confirmed by pathological analysis.
Being followed at M D Anderson Cancer Center and Lyndon B. Johnson General Hospital (LBJ Hospital).
Has consented to participate.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037751

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Genentech

Investigators

Principal Investigator:

Diane C. Bodurka, MD, BS

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01037751 History of Changes
Other Study ID Numbers:	2009-0506
Study First Received:	December 17, 2009
Last Updated:	February 1, 2012
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 09, 2012