Gastrointestinal CancerNCT05137782
The Science of the Art of Palliative Care
A study testing Specialty Palliative Care in people with Gastrointestinal Cancer and Lung Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Lung Cancer, Advanced Cancer
- What is being tested?
- Specialty Palliative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: The Science of the Art of Palliative Care Pilot
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.
Read the 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.
- Conditions
- Gastrointestinal Cancer, Lung Cancer, Advanced Cancer
- Being tested
- Specialty Palliative Care
- Keywords
- Palliative Care
- Medical subject headings
- Gastrointestinal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialty Palliative CareOther
Specialty palliative care, as opposed to primary palliative care.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 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. Receives: Other: Specialty Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (9)
Feasibility as measured by participant interest
Percent of participants approached and interested in participating
Measured: 6 months
Feasibility as measured by enrollment number
Percent of participants approached and enrolled
Measured: 6 months
Feasibility as measured by willingness to be randomized
Percent of participants enrolled and willing to be randomized
Measured: 6 months
Feasibility as measured by procedure completion rate
Percent of participants randomized and completed procedures (specialty palliative care, fMRIs, surveys, bio response measurements).
Measured: 6 months
Feasibility as measured by participant withdrawal rate
Percent of participants not completing each study visit and specialty primary care visit
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start3 Jan 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Principal investigator, Amber Barnato, Dartmouth-Hitchcock Medical Center
- Investigators
- Amber Barnato, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137782
- Sponsor's protocol ID
- STUDY02001223
- Status last verified
- Jan 2024
- First submitted
- 17 Nov 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fanouraki E, Knotts JD, Page CA, Perry A, Wager TD, Wheatley TP, Ahern C, Barnato AE. Neural Correlates of Palliative Care: A Feasibility Trial in Patients with Metastatic Gastrointestinal and Lung Cancer. Res Sq [Preprint]. 2026 May 11:rs.3.rs-9215484. doi: 10.21203/rs.3.rs-9215484/v1.
PubMed 42183384
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Science of the Art of Palliative Care Pilot
- ClinicalTrials.gov ID
- NCT05137782
- Acronym / sponsor ID
- STUDY02001223
- Conditions
- Gastrointestinal Cancer, Lung Cancer, Advanced Cancer
- Keywords
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: Specialty Palliative CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialty Palliative CareSpecialty palliative care, as opposed to primary palliative care. | Other | Arm 1 |
Primary outcome
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.
9 secondary outcomes
Feasibility as measured by participant interest
Time frame: 6 months
Feasibility as measured by enrollment number
Time frame: 6 months
Feasibility as measured by willingness to be randomized
Time frame: 6 months
Feasibility as measured by procedure completion rate
Time frame: 6 months
Feasibility as measured by participant withdrawal rate
Time frame: 6 months
Tolerability as measured by subjective units of distress scores (SUDS, 0-100)
Time frame: 6 months
Tolerability as measured by rates of study procedure non-completion.
Time frame: 6 months
Acceptability as measured by response to questions of level of burden.
Time frame: 6 months
Acceptability as measured by willingness to recommend study participation to others.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 42183384Fanouraki E, Knotts JD, Page CA, Perry A, Wager TD, Wheatley TP, Ahern C, Barnato AE. Neural Correlates of Palliative Care: A Feasibility Trial in Patients with Metastatic Gastrointestinal and Lung Cancer. Res Sq [Preprint]. 2026 May 11:rs.3.rs-9215484. doi: 10.21203/rs.3.rs-9215484/v1.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber Barnato, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialty Palliative Care in people with Gastrointestinal Cancer and Lung Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operationalization as measured by the creation of a manual of operating procedures and web-based data collection forms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.