Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02043158
First received: January 16, 2014
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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 Intervention
Ovarian Cancer
Behavioral: Questionnaire
Behavioral: Interview

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Biobehavioral Information Collection in Ovarian Cancer Survivors [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 240
Study Start Date: January 2014
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Long term and short term ovarian cancer survivors at the University of Texas MD Anderson Cancer Center in Houston, Texas

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043158

Contacts
Contact: Eileen H. Shinn, PHD, MS, BA 713-745-0870

Locations
United States, California
Cedars Sinai Recruiting
West Hollywood, California, United States, 90048
Contact: Marc Goodman, Ph.D.         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Susan Lutgendorf, Ph.D.         
United States, New York
Memorial Sloan Kettering Recruiting
New York, New York, United States, 10065
Contact: Jeanne Carter, Ph.D.         
United States, Oklahoma
University of Oklahoma Recruiting
Norman, Oklahoma, United States, 73019
Contact: Maryanne Matzo, Ph.D.         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Eileen H. Shinn, PHD, MS, BA M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02043158     History of Changes
Other Study ID Numbers: 2013-0626, 1234
Study First Received: January 16, 2014
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Ovarian Cancer
Short term survivors
Long term survivors
Biobehavioral characteristics
Sociodemographic characteristics
Questionnaire
Survey
Interview

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 20, 2014