Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer

NCT ID: NCT02043158

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-16
• Study Completion Date: 2026-12-30

Brief 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.

Detailed 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.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ovarian Cancer Survivors

Short-term and long-term ovarian cancer survivors

Questionnaire

Intervention Type: BEHAVIORAL

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.

Interview

Intervention Type: BEHAVIORAL

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.

Interventions

Questionnaire

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Survey

Eligibility Criteria

Inclusion Criteria

1. For the long-term survivor group: alive for at least seven years post-diagnosis.

2. At least 18 years of age.

3. Can speak and read English.

4. diagnosed with stage III-IV ovarian, peritoneal or fallopian tube cancer

Exclusion Criteria

1. Are in hospice or about to be referred to hospice within the next 3-6 weeks.

2. Are not oriented to time, person, or place.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eileen H. Shinn, PHD, MS, BA

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Cedars Sinai

West Hollywood, California, United States

University of Iowa

Iowa City, Iowa, United States

Memorial Sloan Kettering

New York, New York, United States

University of Oklahoma

Norman, Oklahoma, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

1234

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2021-10800

Identifier Type: OTHER

Identifier Source: secondary_id

2013-0626

Identifier Type: -

Identifier Source: org_study_id