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M. D. Anderson Symptom Inventory - Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT01037751
Recruitment Status : Active, not recruiting
First Posted : December 23, 2009
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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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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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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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037751


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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Additional Information:
University of Texas MD Anderson Cancer Center Website  This link exits the ClinicalTrials.gov site

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    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

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