Clinical trial NCT06374251: Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers
Official title: Can Narrative Medicine Methods Improve Well-Being in Patients With GI Malignancies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Digestive System Neoplasm
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-04-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who complete the narrative medicine sessions
timeFrame: Up to 3 months
measure: Change in well-being scores
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Eve L Makoff, MD
role: PRINCIPAL_INVESTIGATOR
References: