Malignant Digestive System NeoplasmNCT06374251
Narrative Medicine for Improving Well-Being in Patients With Gastrointestinal Cancers
A study testing Discussion, Interview and Survey Administration in people with Malignant Digestive System Neoplasm, run by University of Southern California at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Digestive System Neoplasm
- What is being tested?
- Discussion, Interview and Survey Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Altered mental status or other cognitive impairment, organic or drug induced that would limit ability to participate in the evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Can Narrative Medicine Methods Improve Well-Being in Patients With GI Malignancies
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Malignant Digestive System Neoplasm
- Being tested
- Discussion, Interview, Survey Administration
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionProcedure or surgery
Also called Discuss
Participate in narrative medicine sessions
InterviewOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (narrative medicine sessions) | Experimental | Patients participate in narrative medicine sessions over 60 minutes Q2W for 3 sessions. Receives: Procedure: Discussion; Other: Interview; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start27 Sep 2023
- Primary completion18 Apr 2024
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Digestive System NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eve L Makoff, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374251
- Sponsor's protocol ID
- 0S-23-2
- Other IDs
- NCI-2023-08890, 0S-23-2, P30CA014089
- Status last verified
- Nov 2025
- First submitted
- 15 Apr 2024
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Narrative Medicine Methods Improve Well-Being in Patients With GI Malignancies
- ClinicalTrials.gov ID
- NCT06374251
- Acronym / sponsor ID
- 0S-23-2
- Conditions
- Malignant Digestive System Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (narrative medicine sessions) | Experimental | Procedure: Discussion, Other: Interview, Other: Survey AdministrationPatients participate in narrative medicine sessions over 60 minutes Q2W for 3 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Altered mental status or other cognitive impairment, organic or drug induced that would limit ability to participate in the evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscussionAlso: DiscussParticipate in narrative medicine sessions | Procedure or surgery | Supportive Care (narrative medicine sessions) |
| InterviewAncillary studies | Other | Supportive Care (narrative medicine sessions) |
| Survey AdministrationAncillary studies | Other | Supportive Care (narrative medicine sessions) |
Primary outcome
Number of participants who complete the narrative medicine sessions
Time frame: Up to 3 months
To determine the intervention feasibility, the number of participants who complete the narrative medicine sessions will be tracked.
Change in well-being scores
Time frame: Up to 3 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eve L Makoff, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion, Interview and Survey Administration in people with Malignant Digestive System Neoplasm, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete the narrative medicine sessions (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.