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

NCT ID: NCT06374251

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-27

Study Completion Date

2025-10-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Digestive System Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive Care (narrative medicine sessions)

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

Group Type EXPERIMENTAL

Discussion

Intervention Type PROCEDURE

Participate in narrative medicine sessions

Interview

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Discussion

Participate in narrative medicine sessions

Intervention Type PROCEDURE

Interview

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Discuss

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eve L Makoff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2023-08890

Identifier Type: REGISTRY

Identifier Source: secondary_id

0S-23-2

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0S-23-2

Identifier Type: -

Identifier Source: org_study_id