Myelodysplastic Syndromes
Conditions
Keywords
MDS, Myelodysplastic Syndromes, Quality of life, Tranfusion-dependent
Brief summary
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.
Detailed description
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.
Interventions
OTHERPeri-Transfusion QOL Assessment
Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)
Sponsors
Vera and Joseph Dresner Foundation
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years of age * Patients with MDS * Patients approaching an Hb of 8.5 g/dL during enrollment period OR * Patients with \>1 transfusion scheduled during an 8-week period * Ability to read and understand English
Exclusion criteria
* Age \<18 years * Cr \> 2 * Known CHF * Unstable Angina * Hb level below 7.5 g/dL or above 8.5 g/dL * No plan for future transfusion. * Patient enrollment will happen after patient has consented and scheduled their first/next transfusion. * Patient will not be enrolled if no future transfusions are scheduled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinic Visits (for Both Transfusion Groups) | Two months | Assessed via medical record review at two months post index transfusion |
| Number of Participants With Receipt of Second Transfusion | Two months | Assessed via medical record review at two months post index transfusion |
| Median Difference in Units pRBCs (for Those Transfusion-dependent) | Two months | 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. |
| Number of Hospitalizations (for Both Transfusion Groups) | Two months | Assessed via medical record review at two months post index transfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTQA Utilization | Two months | Assessed via follow-up survey at 2 months after index transfusion |
| Number of Patients With Decisional Regret | Two months | 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. |
| Perceptions of Impact of PTQA on Care | Two months | 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. |
| Perceived Stress by the Associated Scales | Two months | Assessed via follow-up survey at 2 months after index transfusion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peri-Transfusion QOL Assessment * Participants will be given a study packet containing a paper copy of the QUALMS
* Study participants will fill out the survey on the day before their first/next pRBC transfusion.
* Study participants will receive a second paper copy of the QUALMS, along with a stamped envelope addressed to the appropriate site
* The second assessment will be scored and compared with the first, and both the patient and provider will be sent a report with the results
Peri-Transfusion QOL Assessment: Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS) | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Peri-Transfusion QOL Assessment | — |
|---|---|---|
| Age, Continuous | 73 years STANDARD_DEVIATION 11.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
| Transfusion-dependent | 34 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 38 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Two months
Population: Data not collected.
Primary
Number of Clinic Visits (for Both Transfusion Groups)
Assessed via medical record review at two months post index transfusion
Time frame: Two months
Population: Data not collected.
Primary
Number of Hospitalizations (for Both Transfusion Groups)
Assessed via medical record review at two months post index transfusion
Time frame: Two months
Population: Data not collected.
Primary
Number of Participants With Receipt of Second Transfusion
Assessed via medical record review at two months post index transfusion
Time frame: Two months
Population: Data not collected.
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.
Time frame: Two months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peri-Transfusion QOL Assessment | Number of Patients With Decisional Regret | 3 Participants |
Secondary
Perceived Stress by the Associated Scales
Assessed via follow-up survey at 2 months after index transfusion
Time frame: Two months
Population: Data not collected.
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.
Time frame: Two months
Population: Patients who underwent PTQA, were alive and were willing to complete the 2-month follow-up survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peri-Transfusion QOL Assessment | Perceptions of Impact of PTQA on Care | 24 Participants |
Secondary
PTQA Utilization
Assessed via follow-up survey at 2 months after index transfusion
Time frame: Two months
Population: Data not collected.