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Trial Title:
Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers
NCT ID:
NCT06374251
Condition:
Malignant Digestive System Neoplasm
Conditions: Official terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Discussion
Description:
Participate in narrative medicine sessions
Arm group label:
Supportive Care (narrative medicine sessions)
Other name:
Discuss
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Supportive Care (narrative medicine sessions)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Supportive Care (narrative medicine sessions)
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC / Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Eve L. Makoff
Phone:
323-865-3000
Email:
makoff@usc.edu
Investigator:
Last name:
Eve L. Makoff
Email:
Principal Investigator
Start date:
September 27, 2023
Completion date:
March 27, 2025
Lead sponsor:
Agency:
University of Southern California
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Southern California
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06374251
