Myelodysplastic SyndromesNCT03660228
Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS
A study testing Peri-Transfusion QOL Assessment in people with Myelodysplastic Syndromes, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Peri-Transfusion QOL Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: PTQA: A New Paradigm of Transfusion Decision Support for Patients With MDS
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.
Read the 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.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Peri-Transfusion QOL Assessment
- Keywords
- MDS, Myelodysplastic Syndromes, Quality of life, Tranfusion-dependent
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peri-Transfusion QOL AssessmentOther
Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)
| Study group | Role | What they receive |
|---|---|---|
| Peri-Transfusion QOL Assessment | Experimental | * 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 Receives: Other: Peri-Transfusion QOL Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Receipt of Second Transfusion
Assessed via medical record review at two months post index transfusion
Measured: 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.
Measured: Two months
Number of Hospitalizations (for Both Transfusion Groups)
Assessed via medical record review at two months post index transfusion
Measured: Two months
Number of Clinic Visits (for Both Transfusion Groups)
Assessed via medical record review at two months post index transfusion
Measured: Two months
Secondary outcomes (4)
PTQA Utilization
Assessed via follow-up survey at 2 months after index transfusion
Measured: 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.
Measured: 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.
Measured: Two months
Perceived Stress by the Associated Scales
Assessed via follow-up survey at 2 months after index transfusion
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start17 Oct 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Vera and Joseph Dresner Foundation
- Responsible party
- Principal investigator, Gregory A. Abel, MD, Dana-Farber Cancer Institute
- Investigators
- Gregory A Abel, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660228
- Sponsor's protocol ID
- 18-307
- Status last verified
- Jan 2024
- First submitted
- 4 Sep 2018
- Last updated
- 21 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34251040
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTQA: A New Paradigm of Transfusion Decision Support for Patients With MDS
- ClinicalTrials.gov ID
- NCT03660228
- Acronym / sponsor ID
- 18-307
- Conditions
- Myelodysplastic Syndromes
- Keywords
- MDS, Myelodysplastic Syndromes, Quality of life, Tranfusion-dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Vera and Joseph Dresner Foundation
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 21 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 |
|---|---|---|
| Peri-Transfusion QOL Assessment | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Age <18 years
- Cr > 2
- Known CHF
- Unstable Angina
- Hb level below 7.5 g/dL or above 8.5 g/dL
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 |
|---|---|---|
| Peri-Transfusion QOL AssessmentParticipants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS) | Other | Peri-Transfusion QOL Assessment |
Primary outcome
Number of Participants With Receipt of Second Transfusion
Time frame: Two months
Assessed via medical record review at two months post index transfusion
Median Difference in Units pRBCs (for Those Transfusion-dependent)
Time frame: 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)
Time frame: Two months
Assessed via medical record review at two months post index transfusion
Number of Clinic Visits (for Both Transfusion Groups)
Time frame: Two months
Assessed via medical record review at two months post index transfusion
4 secondary outcomes
PTQA Utilization
Time frame: Two months
Number of Patients With Decisional Regret
Time frame: Two months
Perceptions of Impact of PTQA on Care
Time frame: Two months
Perceived Stress by the Associated Scales
Time frame: Two months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34251040Abel 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.
- Individual participant dataSharing planned: No
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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.
Gregory A Abel, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peri-Transfusion QOL Assessment in people with Myelodysplastic Syndromes, run by Dana-Farber Cancer Institute 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 8 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 21 Jun 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?
Yes. Results are posted in the registry (first posted 21 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Receipt of Second Transfusion (time frame: Two months). The study lists 4 primary outcomes in all. 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 NCT03660228, 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 21 Jun 2024.