The Science of the Art of Palliative Care

The Science of the Art of Palliative Care Pilot

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Advanced Cancer; Gastrointestinal Cancer
• Intervention / Treatment: Other: Specialty Palliative Care

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Patients and care partners receive specialty primary care and participate in pre- and post- functional MRI scans to measure the effects of the specialty palliative care intervention.	Other: Specialty Palliative Care; Specialty palliative care, as opposed to primary palliative care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operationalization as measured by the creation of a manual of operating procedures and web-based data collection forms	Establish acceptable operating procedures and data collection instruments which can be replicated for future projects.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as measured by participant interest	Percent of participants approached and interested in participating	6 months
Feasibility as measured by enrollment number	Percent of participants approached and enrolled	6 months
Feasibility as measured by willingness to be randomized	Percent of participants enrolled and willing to be randomized	6 months
Feasibility as measured by procedure completion rate	Percent of participants randomized and completed procedures (specialty palliative care, fMRIs, surveys, bio response measurements).	6 months
Feasibility as measured by participant withdrawal rate	Percent of participants not completing each study visit and specialty primary care visit	6 months
Tolerability as measured by subjective units of distress scores (SUDS, 0-100)	The SUDs Rating Scale, or Subjective Units of Distress Scale (SUDs) as it is officially known, is used to measure the intensity of distress or nervousness in people with social anxiety. The SUDs is a self-assessment tool rated on a scale from 0 to 100.	6 months
Tolerability as measured by rates of study procedure non-completion.	Percent of participants not completing each study procedures (specialty palliative care, fMRIs, surveys, bio response measurements).	6 months
Acceptability as measured by response to questions of level of burden.	Two closed-ended Likert scale items regarding study burdensomeness. (this investigator-created instrument is in development)	6 months
Acceptability as measured by willingness to recommend study participation to others.	Measured by the Net Promoter Score - The Net Promoter Score is an index that measures the willingness of participants to recommend a services to others. It is used as a proxy for gauging overall satisfaction with a service. Net Promoter Score (scale from 0 to 10 with 3 groups: promoters for 9-10, passive for 7-8 and detractor for below 6).	6 months

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Dartmouth College
• Investigators: Principal Investigator: Amber Barnato, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Palliative Care
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: STUDY02001223

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No