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NCT Number: NCT05137782

The Science of the Art of Palliative Care

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.

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Key information

Conditions

Gastrointestinal Cancer Advanced Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Specialty Palliative Care

Other

Specialty palliative care, as opposed to primary palliative care.

Primary outcomes

  1. Operationalization as measured by the creation of a manual of operating procedures and web-based data collection forms

    Time frame: 6 months

    Establish acceptable operating procedures and data collection instruments which can be replicated for future projects.

Secondary outcomes

  1. Feasibility as measured by participant interest

    Time frame: 6 months

    Percent of participants approached and interested in participating

  2. Feasibility as measured by enrollment number

    Time frame: 6 months

    Percent of participants approached and enrolled

  3. Feasibility as measured by willingness to be randomized

    Time frame: 6 months

    Percent of participants enrolled and willing to be randomized

  4. Feasibility as measured by procedure completion rate

    Time frame: 6 months

    Percent of participants randomized and completed procedures (specialty palliative care, fMRIs, surveys, bio response measurements).

  5. Feasibility as measured by participant withdrawal rate

    Time frame: 6 months

    Percent of participants not completing each study visit and specialty primary care visit

  6. Tolerability as measured by subjective units of distress scores (SUDS, 0-100)

    Time frame: 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.

  7. Tolerability as measured by rates of study procedure non-completion.

    Time frame: 6 months

    Percent of participants not completing each study procedures (specialty palliative care, fMRIs, surveys, bio response measurements).

  8. Acceptability as measured by response to questions of level of burden.

    Time frame: 6 months

    Two closed-ended Likert scale items regarding study burdensomeness. (this investigator-created instrument is in development)

  9. Acceptability as measured by willingness to recommend study participation to others.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Dartmouth College

Registry information

Official study title

The Science of the Art of Palliative Care Pilot

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2021
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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