The Science of the Art of Palliative Care
Primary Purpose
Gastrointestinal Cancer, Lung Cancer, Advanced Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specialty Palliative Care
Sponsored by
About this trial
This is an interventional health services research trial for Gastrointestinal Cancer focused on measuring Palliative Care
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Patient: has received a diagnosis of metastatic lung or gastrointestinal cancer within the last 8 weeks *(note: most metastatic 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
- 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).
Sites / Locations
- Dartmouth-Hitchcock Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Feasibility as measured by participant interest
Percent of participants approached and interested in participating
Feasibility as measured by enrollment number
Percent of participants approached and enrolled
Feasibility as measured by willingness to be randomized
Percent of participants enrolled and willing to be randomized
Feasibility as measured by procedure completion rate
Percent of participants randomized and completed procedures (specialty palliative care, fMRIs, surveys, bio response measurements).
Feasibility as measured by participant withdrawal rate
Percent of participants not completing each study visit and specialty primary care visit
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.
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).
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)
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).
Full Information
NCT ID
NCT05137782
First Posted
November 17, 2021
Last Updated
June 22, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Dartmouth College
1. Study Identification
Unique Protocol Identification Number
NCT05137782
Brief Title
The Science of the Art of Palliative Care
Official Title
The Science of the Art of Palliative Care Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Dartmouth College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer, Lung Cancer, Advanced Cancer
Keywords
Palliative Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Specialty Palliative Care
Intervention Description
Specialty palliative care, as opposed to primary palliative care.
Primary Outcome Measure Information:
Title
Operationalization as measured by the creation of a manual of operating procedures and web-based data collection forms
Description
Establish acceptable operating procedures and data collection instruments which can be replicated for future projects.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Feasibility as measured by participant interest
Description
Percent of participants approached and interested in participating
Time Frame
6 months
Title
Feasibility as measured by enrollment number
Description
Percent of participants approached and enrolled
Time Frame
6 months
Title
Feasibility as measured by willingness to be randomized
Description
Percent of participants enrolled and willing to be randomized
Time Frame
6 months
Title
Feasibility as measured by procedure completion rate
Description
Percent of participants randomized and completed procedures (specialty palliative care, fMRIs, surveys, bio response measurements).
Time Frame
6 months
Title
Feasibility as measured by participant withdrawal rate
Description
Percent of participants not completing each study visit and specialty primary care visit
Time Frame
6 months
Title
Tolerability as measured by subjective units of distress scores (SUDS, 0-100)
Description
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.
Time Frame
6 months
Title
Tolerability as measured by rates of study procedure non-completion.
Description
Percent of participants not completing each study procedures (specialty palliative care, fMRIs, surveys, bio response measurements).
Time Frame
6 months
Title
Acceptability as measured by response to questions of level of burden.
Description
Two closed-ended Likert scale items regarding study burdensomeness. (this investigator-created instrument is in development)
Time Frame
6 months
Title
Acceptability as measured by willingness to recommend study participation to others.
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda N Perry, BA
Phone
603-646-5162
Email
amanda.n.perry@dartmouth.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Spalding, MPH
Email
christian.t.spalding@dartmouth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber Barnato, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheryl Page
Email
cheryl.a.page@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Sean Dabney
Email
sean.b.dabney@hitchcock.org
12. IPD Sharing Statement
Plan to Share IPD
No
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The Science of the Art of Palliative Care
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