- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02043158
Biobehavioral and Sociodemographic Characteristics of Long Term Survivors of Ovarian Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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California
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West Hollywood, California, United States, 90048
- Cedars Sinai
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering
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Oklahoma
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Norman, Oklahoma, United States, 73019
- University of Oklahoma
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Texas
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Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Are in hospice or about to be referred to hospice within the next 3-6 weeks.
- Are not oriented to time, person, or place.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Ovarian Cancer Survivors
Short-term and long-term ovarian cancer survivors
|
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:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 day
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eileen H. Shinn, PHD, MS, BA, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Ovarian Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
- Surveys and Questionnaires
Other Study ID Numbers
- 2013-0626
- 1234 (Department of Defense)
- NCI-2021-10800 (Other Identifier: Clinical Trials Reporting Program (CTRP))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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Jiangsu Cancer Institute & HospitalRecruitingOvarian Cancer Metastatic | Ovarian Cancer Metastatic RecurrentChina
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Asan Medical CenterKorean Gynecologic Oncology GroupNot yet recruitingOvarian Cancer Recurrent | Platinum Sensitive Ovarian Cancer
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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University of California, DavisRecruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Centre Leon BerardCancer Côte d'or registry; Cancer Calvados registryUnknownOvarian Epithelial CancerFrance
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Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Nausea and Vomiting | Ovarian Brenner Tumor | Ovarian Mucinous Cystadenocarcinoma | Undifferentiated Ovarian Carcinoma | Stage IIA Fallopian Tube Cancer | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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