Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life

NCT00106717 | Completed

• 1 other identifier: 1736
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer pain; Quality of life; Narrative medicine; Pain relief

Outcome Measures

Primary Outcomes (1)

• Pain intensity

Secondary Outcomes (2)

• Pain interference with general activity, mood, work, relation with others, sleep, and enjoyment of life.

• Health related quality of life

Interventions

Narrative medicine PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients unable to write or read

Sponsors & Collaborators

• Javeriana University: lead

Study Sites (1)

San Ignacio Hospital

Bogotá, DC, Colombia

Location

MeSH Terms

Conditions

Neoplasms; Cancer Pain; Narrative Medicine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narration; Communication; Behavior

Study Officials

• M. Soledad Cepeda, MD, PhD

  Javeriana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 29, 2005
• First Posted: March 30, 2005
• Study Start: January 1, 2004
• Study Completion: August 1, 2006
• Last Updated: March 20, 2008

Record last verified: 2005-03

Locations

CO (1)