Ovarian CancerNCT02043158
Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer
An observational study of Ovarian Cancer, run by M.D. Anderson Cancer Center at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Questionnaire and Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Jan 2014to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Long term and short term ovarian cancer survivors at the University of Texas MD Anderson Cancer Center in Houston, Texas
Who may be able to join
- For the long-term survivor group: alive for at least seven years post-diagnosis.
- At least 18 years of age.
- Can speak and read English.
- diagnosed with stage III-IV ovarian, peritoneal or fallopian tube cancer
Who cannot join
- Are in hospice or about to be referred to hospice within the next 3-6 weeks.
- Are not oriented to time, person, or place.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Memorial Sloan Kettering
New York, New York, 10065
University of Oklahoma
Norman, Oklahoma, 73019
Cedars Sinai
West Hollywood, California, 90048
About this study
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.
Read the 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
- Being tested
- Questionnaire, Interview
- Keywords
- Ovarian Cancer, Short term survivors, Long term survivors, Biobehavioral characteristics, Sociodemographic characteristics, Questionnaire, Survey, Interview
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
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.
InterviewBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian Cancer Survivors | Short-term and long-term ovarian cancer survivors Receives: Behavioral: Questionnaire; Behavioral: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biobehavioral Information Collection in Ovarian Cancer Survivors
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start16 Jan 2014
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Eileen H. Shinn, PHD, MS, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043158
- Sponsor's protocol ID
- 2013-0626
- Other IDs
- 1234, NCI-2021-10800
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2014
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02043158
- Acronym / sponsor ID
- 2013-0626
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian Cancer, Short term survivors, Long term survivors, Biobehavioral characteristics, Sociodemographic characteristics, Questionnaire, Survey, Interview
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 16 Jan 2014 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian Cancer Survivors | – | Behavioral: Questionnaire, Behavioral: InterviewShort-term and long-term ovarian cancer survivors |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Long term and short term ovarian cancer survivors at the University of Texas MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (4 listed)
- For the long-term survivor group: alive for at least seven years post-diagnosis.
- At least 18 years of age.
- Can speak and read English.
- diagnosed with stage III-IV ovarian, peritoneal or fallopian tube cancer
Key exclusion criteria (2 listed)
- Are in hospice or about to be referred to hospice within the next 3-6 weeks.
- Are not oriented to time, person, or place.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyQuestionnaire 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. | Behavioural | Ovarian Cancer Survivors |
| InterviewInterview 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. | Behavioural | Ovarian Cancer Survivors |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen H. Shinn, PHD, MS, BA principal investigator
M.D. Anderson Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by M.D. Anderson Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biobehavioral Information Collection in Ovarian Cancer Survivors (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.