Clinical trial NCT02043158: Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer
Official title: Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Short term survivors
Long term survivors
Biobehavioral characteristics
Sociodemographic characteristics
Questionnaire
Survey
Interview
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2014-01-23
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Biobehavioral Information Collection in Ovarian Cancer Survivors
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: West Hollywood
country: United States
facility: Cedars Sinai
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Norman
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eileen H. Shinn, PHD, MS, BA
role: PRINCIPAL_INVESTIGATOR
References: