The Exceptional Patient in Cancer Care

Advanced Cancer Clinical Trial

Official title:

The Exceptional Patient in Cancer Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543153
• Other study ID #: 2007-0435
• Status: Completed
• Phase: N/A
• First received: October 11, 2007
• Last updated: July 27, 2012
• Start date: August 2007
• Est. completion date: August 2010

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Behavioral:
• Interview
Interview lasting approximately 30-45 minutes.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative Data Collection: Patients' Experience of Exceptional Disease Course		2 Years	No

External Links

•   The University of Texas M.D.Anderson Cancer Center