An interventional study of Specialty Palliative Care in Gastrointestinal Cancer, Lung Cancer and Advanced Cancer, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Health services research
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.
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 7 is below the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 6 months
Feasibility as measured by participant interest
Percent of participants approached and interested in participating
Time frame: 6 months
Feasibility as measured by enrollment number
Percent of participants approached and enrolled
Time frame: 6 months
Feasibility as measured by willingness to be randomized
Percent of participants enrolled and willing to be randomized
Time frame: 6 months
Feasibility as measured by procedure completion rate
Percent of participants randomized and completed procedures (specialty palliative care, fMRIs, surveys, bio response measurements).
Time frame: 6 months
Feasibility as measured by participant withdrawal rate
Percent of participants not completing each study visit and specialty primary care visit
Time frame: 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.
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center