- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00543153
The Exceptional Patient in Cancer Care
The objectives of this study is to conduct a multicenter, dual country (United States and Israel), study examining the experience of patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
The primary aim of the study is to develop a detailed description of patients' experience of an exceptional disease course. The secondary aim is to define the content domain for assessment and measurement of exceptional disease course in patients with cancer and identify lessons learned from these exceptional patients that can be a base for future studies to benefit others.
Study Overview
Detailed Description
The investigators of this study are exploring the experience of people with cancer who are considered by their physicians as having an exceptional course of disease - people who have defied the odds and remain well despite the severity of the original diagnosis.
Participation in this study is completely voluntary. Lessons learned from recorded experience(s) may be helpful to other patients and can be a basis for future studies that may benefit other patients.
To participate in this important study is simple and not time consuming. You will have only one face-to-face or telephone interview with a research assistant. During the interview you will simply be asked to describe your perspective, thoughts, and behaviors that you think are related to your disease course and lessons that you think others may gain benefit from. The interview will last about one hour and will be conducted at a time that is convenient for you.
If you agree to participate a research assistant will schedule a time for a recorded interview by phone or if possible at a location convenient to you. The interviews will be taped and transcribed. All recorded interviews will be retained for a minimum of 6 years.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tel Aviv, Israel, 64239
- Tel Aviv University
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Texas
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Houston, Texas, United States, 77030
- UT MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- Ability to speak and read English with patients residing in the US, ability to speak and read Hebrew with patients residing in Israel.
- Diagnosis of cancer confirmed by pathology.
- Exceptional disease course as identified by patients' physician, in terms of survival and unusual disease course that is appropriately medically documented.
- Consent to participate in this study.
Exclusion Criteria:
- Inability to understand the intent of the study.
- Medical condition that would preclude participation in an interview session lasting 30-45 minutes.
- Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients diagnosed with cancer
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Interview lasting approximately 30-45 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Qualitative Data Collection: Patients' Experience of Exceptional Disease Course
Time Frame: 2 Years
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2 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Moshe A. Frenkel, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2007-0435
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.
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