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| Name | Class |
|---|---|
| American Society of Transplantation and Cellular Therapy | UNKNOWN |
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Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. This study will assess Sentinel's feasibility and acceptability.
Patients hospitalized for hematopoietic cell transplantation (HCT) experience physical and psychological symptoms that lead to a deterioration in quality of life (QOL). Integrating specialty palliative care (PC) reduces physical and psychological symptom burden and improves QOL during HCT hospitalization. However, specialty PC remains unavailable and underused at many HCT centers. Primary PC - or training HCT clinicians to deliver PC domains as part of routine practice - is an alternative model of supportive care. We have developed Sentinel, a primary PC intervention for HCT clinicians and patients. We will train HCT clinicians to deliver PC to patients before and during HCT hospitalization. This study will assess Sentinel's feasibility and acceptability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel, primary palliative care intervention | Experimental | All participants will receive Sentinel, a primary palliative care intervention, in this single-arm feasibility trial. Participants will complete patient-reported assessments at the following time points:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary palliative care | Behavioral | Enrolled patient participants will receive Sentinel prior to and during their hospitalization for HCT. Prior to HCT, a transplant clinician (nurse practitioner - NP) will conduct a focused PC visit to build rapport, manage expectations regarding HCT, review anticipated symptoms, and discuss illness coping strategies. During the HCT hospitalization, HCT physicians and advanced practice providers will incorporate PC domains into their routine care of patients undergoing HCT. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | We will assess feasibility of Sentinel based on the proportion of eligible patients who enroll and the proportion of enrolled patients retained. Sentinel will be deemed feasible if at least 60% of eligible patients are enrolled in the study and patient retention through study procedures is at least 80%, commonly utilized metrics in PC trials | Up to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | The intervention will be acceptable for patients if at least 80% of patients report intervention satisfaction (Client Satisfaction Questionnaire mean greater than or equal 3.0/4.0) | At Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | We will assess longitudinal quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) | Up to Day 90 |
| Physical Symptoms | We will assess longitudinal physical symptom burden using the Edmonton Symptom Assessment System - Revised (ESAS-r) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard A Newcomb, MD | Contact | 617-996-7584 | richard.newcomb@mgh.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02152 | United States |
The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the study investigator at richard.newcomb@mgh.harvard.edu
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Single arm feasibility clinical trial
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| Up to Day 90 |
| Anxiety Symptoms | We will assess longitudinal symptoms of depression with the Hospital Anxiety and Depression Scale (HADS) | Up to Day 90 |
| Depression Symptoms | We will assess symptoms of depression with the Hospital Anxiety and Depression Scale (HADS) | Up to Day 90 |
| Post-traumatic stress symptoms | We will assess longitudinal symptoms of post-traumatic stress using the Post-traumatic Stress Checklist-Civilian Version (PCL-C) | Up to Day 90 |
| Coping | We will use select subscales of the Brief-COPE, a 28-item questionnaire that assess patients' use of 14 methods of coping per a 4-point Likert scale. Coping will be classified as 'Approach-oriented' and 'Avoidant' | Up to Day 90 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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