Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of 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: NCT02043158|
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : April 2, 2018
|Condition or disease||Intervention/treatment|
|Ovarian Cancer||Behavioral: Questionnaire Behavioral: Interview|
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer|
|Actual Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2021|
Ovarian Cancer Survivors
Short-term and long-term ovarian cancer survivors
Questionnaire completion asking questions about quality of life, mood, social support, stress, diet, lifestyle, and demographic information. Questionnaire should take about 60-90 minutes to complete.
Other Name: SurveyBehavioral: Interview
Interview asking questions about the amount of stress participant may be having or have had in the past. It should take about 25-30 minutes to complete the interview.
- Biobehavioral Information Collection in Ovarian Cancer Survivors [ Time Frame: 1 day ]Biobehavioral information collected regarding social support, depressed mood, life stress, quality of life, meaning in life, socioeconomic and relationship status, and lifestyle factors such as exercise and diet, which have been linked with cancer progression and/or survival in cancer patients.
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): NCT02043158
|United States, California|
|West Hollywood, California, United States, 90048|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, New York|
|Memorial Sloan Kettering|
|New York, New York, United States, 10065|
|United States, Oklahoma|
|University of Oklahoma|
|Norman, Oklahoma, United States, 73019|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eileen H. Shinn, PHD, MS, BA||M.D. Anderson Cancer Center|