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M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

M. D. Anderson Symptom Inventory - Ovarian Cancer: Development and Validation in Patients With Ovarian Cancer


PART 1

Interview:

If you agree to take part in this study, you will be interviewed about what it is like to
have ovarian cancer and any symptoms that you may have experienced. This will be a 1-on-1
interview with the study doctor or a member of the study staff. It will take place during 1
of your regularly scheduled, standard of care clinic visit and should take about 30 minutes
to complete.

The interview will be digitally recorded. The electronic recording of the interview will be
given a code number and stored on a password-protected computer at M. D. Anderson. No
identifying information will be directly linked to your interview recording. Only the
researcher in charge of the computer will have access to the code numbers and be able to
link the interview recording to you.

Questionnaires:

After the interview, you will also complete a symptom questionnaire, a quality-of-life
questionnaire, and a demographic questionnaire that asks questions about your age, race, and
marital status. You will complete the questionnaires after the interview during the same
clinic visit. It should take about 10 minutes to complete all 3 questionnaires.

You should contact the study doctor or study nurse right away if at any time you are
experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate
them on the symptom questionnaire.

The questionnaires will also be given a code number and stored in a locked file cabinet at
MD Anderson. No identifying information will be directly linked to your questionnaires.
Only the researcher in charge of the study will have access to the code numbers and be able
to link the questionnaires to you.

Length of Study:

After you have completed the interview and the questionnaires, your participation on this
study will be over.

This is an investigational study. Up to 15 participants will take part in this study. All
will be enrolled at MD Anderson.

PART 2

Questionnaires:

If you agree to take part in this study, you will complete the following:

1. A symptom questionnaire, 2 quality-of-life questionnaires, and a demographic
questionnaire that asks questions about your age, race, and marital status. It should
take about 20 minutes to complete all 4 questionnaires.

2. About 1 to 5 days after you complete the first set of questionnaires, you will be asked
to complete a questionnaire either through phone interview with the study staff or
through a mail-in survey . If you complete the questionnaire by mail-in survey, the
study staff will give you a copy of the questionnaire and a stamped pre-addressed
envelope. The questionnaire will take 5-10 minutes to complete.

You should contact the study doctor or study nurse right away if at any time you are
experiencing severe, troublesome, or intolerable symptoms. You should also remember to rate
them on the symptom questionnaire.

The questionnaires will be given a code number and stored in a locked file cabinet at MD
Anderson. No identifying information will be directly linked to your questionnaires. Only
the researcher in charge of the study will have access to the code numbers and be able to
link the questionnaires to you.

Opinion Questionnaire:

If you are one of the first 20 patients enrolled in the study, you will be asked questions
about your opinion of the symptom questionnaire. For example, you will be asked if the
symptom questionnaire was easy to understand and complete, and if there were any other
questions that should be included. The study staff will use your opinion to decide if
changes should be made to the questionnaire or if important symptom questions are missing
from the questionnaire. This questionnaire should take about 5 minutes to complete.

Length of Study:

After you have completed the questionnaires, your participation on this study will be over.

This is an investigational study. Up to 128 participants will take part in this study. All
will be enrolled at MD Anderson and Lyndon B. Johnson General Hospital.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

Baseline to 2 years (Patient participation done after completing Interview and Surveys during single clinic visit)

Safety Issue:

No

Principal Investigator

Diane C. Bodurka, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0506

NCT ID:

NCT01037751

Start Date:

December 2009

Completion Date:

Related Keywords:

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

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030