Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers

Can Narrative Medicine Methods Improve Well-Being in Patients With GI Malignancies

This clinical trial assesses whether narrative medicine methods may improve the sense of well-being among gastrointestinal (GI) (digestive system) cancer patients. Narrative medicine is a clinical approach where providers can use a patient's own narrative (perspective) of their illness to promote healing and resilience. By applying narrative medicine's main tool, close reading, to clinical practice, clinicians learn to listen and attend to patients more deeply. This allows for freer communication and the creation of a healthcare encounter that centers on the psychological and emotional well being of the patient in addition to their medical conditions. Narrative medicine can include close reading, creative or reflective writing, and discussion. These methods may help patients with GI cancer to reflect on their life stories, both inside and outside of their illness experience, and help them gather skills to optimize their well-being.

Study Overview

• Status: Completed
• Conditions: Malignant Digestive System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Procedure: Discussion

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the feasibility of implementing narrative medicine tools in serial workshops with patients with malignancy.

II. To determine if narrative medicine interventions improve markers and expressions of well-being.

DESCRIPTIVE OBJECTIVES:

I. To estimate changes in markers and expressions of well-being after 3 sessions of narrative medicine intervention.

II. To determine, through qualitative methods, if patients find benefit from the intervention regarding their well-being.

III. To decide whether to expand these kinds of interventions to a larger study with control group.

OUTLINE:

Patients participate in narrative medicine sessions over 60 minutes once every 2 weeks (Q2W) for 3 sessions.

After completion of study intervention, patients are followed up at 1 and 3 months.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with diagnosis of gastrointestinal malignancy actively receiving infusional therapy for cancer.
• Age >= 18 years.
• English speaking with ability to participate in reading and writing questionnaires and implementation tools.
• Performance Status =< Eastern Cooperative Oncology Group (ECOG) 3.

Exclusion Criteria:

• Altered mental status or other cognitive impairment, organic or drug induced that would limit ability to participate in the evaluation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supportive Care (narrative medicine sessions); Patients participate in narrative medicine sessions over 60 minutes Q2W for 3 sessions.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Procedure: Discussion; Participate in narrative medicine sessions; Other Names: Discuss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who complete the narrative medicine sessions	To determine the intervention feasibility, the number of participants who complete the narrative medicine sessions will be tracked.	Up to 3 months
Change in well-being scores	Will be evaluated using the Edmonton Symptom Assessment System-Revised Version (ESAS-r). The total score ranges from 0 to 10, with a higher score indicating worse outcomes.	Up to 3 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eve L Makoff, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Actual): April 18, 2024
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: 0S-23-2 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2023-08890 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No