Clinical trial NCT05137782: The Science of the Art of Palliative Care
Official title: The Science of the Art of Palliative Care Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Lung Cancer
Advanced Cancer
Keywords: Palliative Care
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Dartmouth College
First posted: 2021-11-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This feasibility pilot study is designed to learn whether patients and their care partners (e.g., family members) are willing and able to complete two study visits at Dartmouth College while receiving cancer care at Dartmouth-Hitchcock Medical Center.

Detailed description: A feasibility pilot open label, single-arm observational case series of 10 patients with metastatic gastrointestinal and lung cancer patients and 10 care partners. Participants will complete two study visits, separated by approximately 8-16 weeks of usual oncologic care with early integrated specialty palliative care. The palliative care physician will also be a study participant.

Primary Objective: To develop and refine study procedures which can be used in future research in order to further understanding of the mechanisms of action of specialty palliative. Expected products: manual of operating procedures and web-based data collection forms.

Secondary Objectives: To test the feasibility of conducting a mechanism-focused clinical trial of primary palliative care vs. specialty palliative care for advanced cancer patients and their care partners. Expected products: preliminary data demonstrating the feasibility of study procedures sufficient to prove this study design is possible.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Patient: has received a diagnosis of advanced lung or gastrointestinal cancer within the last 24 weeks (note: advanced GI cancer will likely be pancreatic or colorectal)
* Care partner: care partner of a patient who has received a diagnosis of metastatic lung or gastrointestinal cancer who has provided consent for study (either with our without functional MRI study visits)
* Be able to understand study requirements and make an informed decision to participate
* Be able to speak and read English

Exclusion Criteria:

* Life expectancy of \<8 weeks
* Known brain metastases
* Claustrophobia
* Both patient and care partner refuse to participate in fMRI scan (ie., either patient or care partner must agree to an fMRI scan in order for either to participate)
* Contraindications to MRI (e.g.: implanted or embedded metal/metal fragments. Metals in the body make the participant unable to undergo an MRI which makes them ineligible for study participation).

Primary outcomes:
measure: Operationalization as measured by the creation of a manual of operating procedures and web-based data collection forms
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility as measured by participant interest
timeFrame: 6 months
measure: Feasibility as measured by enrollment number
timeFrame: 6 months
measure: Feasibility as measured by willingness to be randomized
timeFrame: 6 months
measure: Feasibility as measured by procedure completion rate
timeFrame: 6 months
measure: Feasibility as measured by participant withdrawal rate
timeFrame: 6 months
measure: Tolerability as measured by subjective units of distress scores (SUDS, 0-100)
timeFrame: 6 months
measure: Tolerability as measured by rates of study procedure non-completion.
timeFrame: 6 months
measure: Acceptability as measured by response to questions of level of burden.
timeFrame: 6 months
measure: Acceptability as measured by willingness to recommend study participation to others.
timeFrame: 6 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Amber Barnato, MD
role: PRINCIPAL_INVESTIGATOR
References: