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M. D. Anderson Symptom Inventory - Ovarian Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01037751
First received: December 17, 2009
Last updated: April 20, 2017
Last verified: April 2017
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Purpose
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 | 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:
Genetics Home Reference related topics:
ovarian cancer
MedlinePlus related topics:
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) ]
Secondary Outcome Measures:
- Patient Rated Symptom Severity and Interference with Function (Survey Response) [ Time Frame: Baseline to 2 years ]
| Estimated Enrollment: | 158 |
| Actual Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | December 2019 (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 (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:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037751
Please refer to this study by its ClinicalTrials.gov identifier: 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
Additional Information:
| 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: | April 20, 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 |
ClinicalTrials.gov processed this record on August 18, 2017