The Science of the Art of Palliative Care

NCT05137782 | Completed DMC

• 1 other identifier: STUDY02001223
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer; Lung Cancer; Advanced Cancer

Keywords

Palliative Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Feasibility as measured by participant interest

  6 months

• Feasibility as measured by enrollment number

  6 months

• Feasibility as measured by willingness to be randomized

  6 months

• Feasibility as measured by procedure completion rate

  6 months

• Feasibility as measured by participant withdrawal rate

  6 months

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

Specialty Palliative Care OTHER

Specialty palliative care, as opposed to primary palliative care.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Amber Barnato, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, The Dartmouth Institute

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 30, 2021
• Study Start: January 3, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)