Clinical trial NCT00543153: The Exceptional Patient in Cancer Care
Official title: The Exceptional Patient in Cancer Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Keywords: Advanced Cancer
Exceptional Patient
Cancer Care
Interview
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-10-12
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, 18 years of age or older, dianosed with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Ability to speak and read English with patients residing in the US, ability to speak and read Hebrew with patients residing in Israel.
3. Diagnosis of cancer confirmed by pathology.
4. Exceptional disease course as identified by patients' physician, in terms of survival and unusual disease course that is appropriately medically documented.
5. Consent to participate in this study.

Exclusion Criteria:

1. Inability to understand the intent of the study.
2. Medical condition that would preclude participation in an interview session lasting 30-45 minutes.
3. Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.

Primary outcomes:
measure: Qualitative Data Collection: Patients' Experience of Exceptional Disease Course
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Moshe A. Frenkel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frenkel M, Ari SL, Engebretson J, Peterson N, Maimon Y, Cohen L, Kacen L. Activism among exceptional patients with cancer. Support Care Cancer. 2011 Aug;19(8):1125-32. doi: 10.1007/s00520-010-0918-6. Epub 2010 May 29.