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| Name | Class |
|---|---|
| Vera and Joseph Dresner Foundation | OTHER |
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This research study is evaluating how to best tailor blood transfusion decisions to match the quality of life changes experienced by individual patients with MDS.
Each patient with MDS reacts differently to blood transfusions; some will feel better after transfusion, while others may not. The main purpose of this survey study is to determine whether it is possible to use quality of life changes - as measured by a validated questionnaire - experienced by individual patients to help physicians and patients with MDS make decisions regarding future blood transfusions. This research is being done because the investigators hope to help doctors better understand the impact of blood transfusions on the quality of life of each patient.
The study uses a standardized MDS-specific quality of life questionnaire that participants will fill out before and after an upcoming transfusion. The investigators will compare the scores of these questionnaires and notify both the participant and provider if the participant has experienced any changes (positive or negative) in his/her quality of life before and after transfusion. The investigators' hope is that doctor-patient teams will use this quality of life information to determine whether the participant should continue receiving transfusions, decrease the frequency of transfusions, or stop receiving transfusions altogether if not needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-Transfusion QOL Assessment | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peri-Transfusion QOL Assessment | Other | Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Receipt of Second Transfusion | Assessed via medical record review at two months post index transfusion | Two months |
| Median Difference in Units pRBCs (for Those Transfusion-dependent) | Assessed via medical record review at two months post index transfusion. We identified historical matches for 25 patients (21 from Dana-Farber, 1 from Wake Forest, and 3 from Yale) and compared the median number of red cell units in these patients to the PTQA group over 2 months. | Two months |
| Number of Hospitalizations (for Both Transfusion Groups) | Assessed via medical record review at two months post index transfusion | Two months |
| Number of Clinic Visits (for Both Transfusion Groups) | Assessed via medical record review at two months post index transfusion | Two months |
| Measure | Description | Time Frame |
|---|---|---|
| PTQA Utilization | Assessed via follow-up survey at 2 months after index transfusion | Two months |
| Number of Patients With Decisional Regret | Assessed via follow-up survey at 2 months after index transfusion. Of the 38 patients who completed PTQA, 6 did not complete the 2-month follow-up survey, and 1 passed away. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory A Abel, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34251040 | Result | Abel GA, Klepin HD, Magnavita ES, Jaung T, Lu W, Shallis RM, Hantel A, Bahl NE, Dellinger-Johnson R, Winer ES, Zeidan AM. Peri-transfusion quality-of-life assessment for patients with myelodysplastic syndromes. Transfusion. 2021 Oct;61(10):2830-2836. doi: 10.1111/trf.16584. Epub 2021 Jul 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peri-Transfusion QOL Assessment |
Peri-Transfusion QOL Assessment: Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peri-Transfusion QOL Assessment |
Peri-Transfusion QOL Assessment: Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Receipt of Second Transfusion | Assessed via medical record review at two months post index transfusion | Data not collected. | Posted | Two months |
|
All-Cause Mortality was monitored/assessed from baseline (index transfusion) to 1 year.
Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peri-Transfusion QOL Assessment |
Peri-Transfusion QOL Assessment: Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory A. Abel, MD | Dana-Farber Cancer Institute | 617-632-2304 | GAABEL@PARTNERS.ORG |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 17, 2019 | Jun 17, 2022 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Two months |
| Perceptions of Impact of PTQA on Care | Percentage of patients reporting that PTQA impacted their treatment decisions. Assessed by a binary (yes/no) on the follow-up survey at 2-months after index transfusion. | Two months |
| Perceived Stress by the Associated Scales | Assessed via follow-up survey at 2 months after index transfusion | Two months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Transfusion-dependent | Patients with greater than or equal to 1 transfusion scheduled during 8-week period prior to enrollment | Count of Participants | Participants |
|
|
| Primary | Median Difference in Units pRBCs (for Those Transfusion-dependent) | Assessed via medical record review at two months post index transfusion. We identified historical matches for 25 patients (21 from Dana-Farber, 1 from Wake Forest, and 3 from Yale) and compared the median number of red cell units in these patients to the PTQA group over 2 months. | Data not collected. | Posted | Two months |
|
|
| Primary | Number of Hospitalizations (for Both Transfusion Groups) | Assessed via medical record review at two months post index transfusion | Data not collected. | Posted | Two months |
|
|
| Primary | Number of Clinic Visits (for Both Transfusion Groups) | Assessed via medical record review at two months post index transfusion | Data not collected. | Posted | Two months |
|
|
| Secondary | PTQA Utilization | Assessed via follow-up survey at 2 months after index transfusion | Data not collected. | Posted | Two months |
|
|
| Secondary | Number of Patients With Decisional Regret | Assessed via follow-up survey at 2 months after index transfusion. Of the 38 patients who completed PTQA, 6 did not complete the 2-month follow-up survey, and 1 passed away. | Posted | Count of Participants | Participants | Two months |
|
|
|
| Secondary | Perceptions of Impact of PTQA on Care | Percentage of patients reporting that PTQA impacted their treatment decisions. Assessed by a binary (yes/no) on the follow-up survey at 2-months after index transfusion. | Patients who underwent PTQA, were alive and were willing to complete the 2-month follow-up survey. | Posted | Count of Participants | Participants | Two months |
|
|
|
| Secondary | Perceived Stress by the Associated Scales | Assessed via follow-up survey at 2 months after index transfusion | Data not collected. | Posted | Two months |
|
|
| 1 |
| 38 |
| 0 |
| 0 |
| 0 |
| 0 |
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