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The purpose of the research is to assess the feasibility and acceptability of a home blood transfusion program for patients with hematologic malignancies who need blood transfusions
This feasibility study will be used to assess the feasibility and acceptability of a hospice-embedded home transfusion program to patients with hematologic malignancies. All enrolled subjects will be patients cared for at Dana Farber Cancer Institute.
This study is a single-arm study of 10 patients with advanced hematologic malignancies who have a limited life-expectancy of six months or fewer and are hospice eligible.
10 Caregivers of enrolled patients will also be invited to participate if interested.
This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed.
Participants will be in the research study for up to six months.
It is expected that about 20 people will take part in this research study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Transfusion | Experimental | This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home Transfusion Program Components | Other | The Home Transfusion Program will include trained transfusion nurse(s) who will administer transfusions in the home setting. The transfusion nurse, who is part of the study team, will work closely with the DFCI/BWH Blood Bank and the hospice agency (Care Dimensions Inc.) that all study patients are enrolled in. The transfusion nurse will administer home transfusions using safe home transfusion practices endorsed by the AABB. The home transfusion program has 4 key aspects Initial home visit, (2) subsequent contact, (3) home transfusion assessment & administration, (4) usual elements of hospice |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | Number of patients consented to the study divided by eligible patients approached by the study team | 6 months |
| Completion of Home Transfusions and Patient-Reported Data | Proportion of completed home transfusions among enrolled patients who meet transfusion criteria, and proportion of enrolled patients who complete patient-reported data collection | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction Rate | Proportion of enrolled patients who are satisfied with the home transfusion program and proportion of enrolled patients who are likely to recommend the home transfusion program. | 3 Weeks |
| Disenrollment Rate |
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Inclusion Criteria:
Patients with advanced hematologic malignancies:
Caregivers:
Exclusion Criteria:
Patients
Caregiver
Age < 18 years
Our study will exclude members of the following special populations:
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| Name | Affiliation | Role |
|---|---|---|
| Oreofe O Odejide, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | 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 Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| 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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Proportion of study participants who disenroll from the study.
| 6 months |