Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02043158 |
| Other study ID # |
2013-0626 |
| Secondary ID |
1234 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 16, 2014 |
| Est. completion date |
December 30, 2026 |
Study information
| Verified date |
March 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this research study is to learn about diet and exercise habits, emotions, and
social support in the lives of women with ovarian cancer.
Description:
Study Participation:
If you agree to take part in this study, you will fill out a questionnaire, complete an
interview, and information will be collected from your medical record.
For the questionnaire, you will answer questions about your quality of life, mood, social
support, stress, diet, lifestyle, and demographic information (such as your age and race).
The questionnaire should take about 60-90 minutes to complete. If you prefer to fill out the
questionnaire online, 3 separate emails will be sent to your email address. Each email will
contain a separate link (the first link will be sent from MD Anderson, the second from
University of Arizona for the diet questions, and the third from the University of California
Los Angeles [UCLA] for the stress questions).
You will also be asked to measure your waist and your hip with a measuring tape and to record
the measurements on the questionnaire.
If you prefer to fill out the questionnaire by paper format, you should mail it back to the
research staff. However, the stress questions will need to done by phone. A trained
interviewer will ask you questions about the amount of stress you may be having or have had
in the past. It should take about 25-30 minutes to complete the interview.
If you are a long-term survivor, you will have an interview by phone that will ask for your
opinions about the factors that may have contributed to your survival. This interview will
take about 45 minutes to an hour and will be audio-recorded. Your name and identifying
information will not be recorded.
Information collected from your medical record will include the status of the disease, if the
disease has gotten worse, any treatments you have received, and any side effects you may have
had. This information will help researchers learn how specific treatments may affect
patients.
If you are already enrolled in a protocol in which you will be having tumor tissue collected
for future analysis, the information gathered in those studies will be used together with the
data collected for this study to learn if behavioral factors relate to your tumor tissue test
results.
Length of Study:
Your study participation will be over after completing the questionnaire and interview.
Other Information:
Before any information is recorded, you will be asked for your permission.
The tape recording will be done by members of the study staff. Your audiotape will be given a
code number. No identifying information (such as your name and medical record number) will be
recorded on the audiotape.
This is an investigational study.
Up to 240 participants will be enrolled in this multicenter study. Up to 120 will take part
at MD Anderson.
