Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life

This study has been completed.
Sponsor:
Information provided by:
Javeriana University
ClinicalTrials.gov Identifier:
NCT00106717
First received: March 29, 2005
Last updated: March 19, 2008
Last verified: March 2005
  Purpose

Narrative medicine addresses the therapeutic benefits that derive from patients forming and telling their personal stories. It offers an innovative model for improving health outcomes. When a patient with cancer and marked suffering writes a narrative of what he or she is going through, this process may reduce pain and improve quality of life.

Therefore, we seek to evaluate the effectiveness of writing a narrative on pain intensity and health related quality of life.

We propose a randomized single blind (evaluator) controlled trial. Patients with cancer pain of intensity at least 5/10 with a minimum Karnofsky score of 50% will be randomized into three groups: 1. Narrative group. Patients will write a story about their illness for at least 20 minutes once a week for 3 weeks; 2. Writing-control group. Patients will fill a pain diary once a week for three weeks; 3. Control group. Subjects will not write/fill anything. Pain will be evaluated using the numerical scale before randomization and then weekly for 8 weeks. We will also evaluate how pain interferes with general activity, mood, work, relation with others, sleep, and enjoyment of life using the Brief Pain Inventory. As secondary outcomes, we will evaluate health related quality of life, with the treatment outcomes of pain survey, which is a modification of the SF 36 (short form health survey), and a global measure of well-being before randomization, and then at 4 and 8 weeks. We will also evaluate the emotional disclosure of the narratives.

We will use an intention to treat analysis. To analyze the effect of the treatment on pain intensity, quality of life, and well-being, we will employ an analysis of repeated measures using generalized estimating equations. We will include in the regression models the treatment group, the emotional disclosure score, the time, and the interaction between treatment group and time.


Condition Intervention
Cancer
Procedure: Narrative medicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life

Further study details as provided by Javeriana University:

Primary Outcome Measures:
  • Pain intensity

Secondary Outcome Measures:
  • Pain interference with general activity, mood, work, relation with others, sleep, and enjoyment of life.
  • Health related quality of life

Estimated Enrollment: 210
Study Start Date: January 2004
Study Completion Date: August 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cancer pain of intensity at least 5/10 with a minimum Karnofsky score of 50%

Exclusion Criteria:

  • Patients unable to write or read
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106717

Locations
Colombia
San Ignacio Hospital
Bogota, DC, Colombia
Sponsors and Collaborators
Javeriana University
Investigators
Principal Investigator: M. Soledad Cepeda, MD, PhD Javeriana University School of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00106717     History of Changes
Other Study ID Numbers: 1736
Study First Received: March 29, 2005
Last Updated: March 19, 2008
Health Authority: Colombia: Institutional Review Board

Keywords provided by Javeriana University:
Cancer pain
Quality of life
Narrative medicine
Pain relief

ClinicalTrials.gov processed this record on September 29, 2014