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

Malignant Digestive System Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374251
• Other study ID #: 0S-23-2
• Secondary ID: NCI-2023-088900S
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: March 27, 2025

Study information

• Verified date: April 2024
• Source: University of Southern California
• Contact: Charlean Ketchens, RN
• Phone: 323-865-0451
• Email: ketchens_c[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 27, 2025
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Malignant Digestive System Neoplasm

Intervention

Procedure:
• Discussion
Participate in narrative medicine sessions

Other:
• Interview
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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