The Science of the Art of Palliative Care

NCT ID: NCT05137782

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2023-11-30

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.

Conditions

Gastrointestinal Cancer; Lung Cancer; Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Specialty Palliative Care

Intervention Type: OTHER

Specialty palliative care, as opposed to primary palliative care.

Interventions

Specialty Palliative Care

Specialty palliative care, as opposed to primary palliative care.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth College

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amber Barnato

Director, The Dartmouth Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amber Barnato, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

STUDY02001223

Identifier Type: -

Identifier Source: org_study_id