Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02043158
Collaborator
United States Department of Defense (U.S. Fed)
240
5
107.4
48
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Questionnaire
  • Behavioral: Interview

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer
Actual Study Start Date :
Jan 16, 2014
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Ovarian Cancer Survivors

Short-term and long-term ovarian cancer survivors

Behavioral: 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.
Other Names:
  • Survey
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Biobehavioral Information Collection in Ovarian Cancer Survivors [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars Sinai West Hollywood California United States 90048
    2 University of Iowa Iowa City Iowa United States 52242
    3 Memorial Sloan Kettering New York New York United States 10065
    4 University of Oklahoma Norman Oklahoma United States 73019
    5 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • United States Department of Defense

    Investigators

    • Principal Investigator: Eileen H. Shinn, PHD, MS, BA, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02043158
    Other Study ID Numbers:
    • 2013-0626
    • 1234
    First Posted:
    Jan 23, 2014
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022