M. D. Anderson Symptom Inventory - Ovarian Cancer
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01037751 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 23, 2009
Last Update Posted
: April 24, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |

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

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

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