The Exceptional Patient in Cancer Care

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00543153
First received: October 11, 2007
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Advanced Cancer
Behavioral: Interview

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Exceptional Patient in Cancer Care

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Qualitative Data Collection: Patients' Experience of Exceptional Disease Course [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: August 2007
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients diagnosed with cancer Behavioral: Interview
Interview lasting approximately 30-45 minutes.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543153

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Israel
Tel Aviv University
Tel Aviv, Israel, 64239
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Moshe A. Frenkel, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00543153     History of Changes
Other Study ID Numbers: 2007-0435
Study First Received: October 11, 2007
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Exceptional Patient
Cancer Care
Interview

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014