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

NCT06374251 | Completed DMC

• 3 other identifiers: 0S-23-2NCI-2023-08890P30CA014089
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Digestive System Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Supportive Care (narrative medicine sessions)

EXPERIMENTAL

Patients participate in narrative medicine sessions over 60 minutes Q2W for 3 sessions.

Procedure: Discussion; Other: Interview; Other: Survey Administration

Interventions

Discussion PROCEDURE

Participate in narrative medicine sessions

Also known as: Discuss

Supportive Care (narrative medicine sessions)

Interview OTHER

Ancillary studies

Supportive Care (narrative medicine sessions)

Survey Administration OTHER

Ancillary studies

Supportive Care (narrative medicine sessions)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eve L Makoff, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: September 27, 2023
• Primary Completion: April 18, 2024
• Study Completion: October 21, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)