The Science of the Art of Palliative Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Science of the Art of Palliative Care Pilot

Conditions
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Gastrointestinal Cancer, Lung Cancer, Advanced Cancer

Intervention / Treatment
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* Other: Specialty Palliative Care


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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<br>* Specialty palliative care, as opposed to primary palliative care.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Care