The Science of the Art of Palliative Care
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Operationalization as measured by the creation of a manual of operating procedures and web-based data collection forms [6 months]
Establish acceptable operating procedures and data collection instruments which can be replicated for future projects.
Secondary Outcome Measures
- Feasibility as measured by participant interest [6 months]
Percent of participants approached and interested in participating
- Feasibility as measured by enrollment number [6 months]
Percent of participants approached and enrolled
- Feasibility as measured by willingness to be randomized [6 months]
Percent of participants enrolled and willing to be randomized
- Feasibility as measured by procedure completion rate [6 months]
Percent of participants randomized and completed procedures (specialty palliative care, fMRIs, surveys, bio response measurements).
- Feasibility as measured by participant withdrawal rate [6 months]
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) [6 months]
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. [6 months]
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. [6 months]
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. [6 months]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or older
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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)
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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)
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Be able to understand study requirements and make an informed decision to participate
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Be able to speak and read English
Exclusion Criteria:
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Life expectancy of <8 weeks
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Known brain metastases
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Claustrophobia
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
Sponsors and Collaborators
- Dartmouth-Hitchcock Medical Center
- Dartmouth College
Investigators
- Principal Investigator: Amber Barnato, MD, Dartmouth-Hitchcock Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY02001223