Myelodysplastic SyndromesNCT03558386
Study of Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes
An observational study of Myelodysplastic Syndromes and Hematopoietic Cell Transplant, run by Center for International Blood and Marrow Transplant Research at 6 sites in United States.
Trial summary
This is a multi-center, Phase II, cross-sectional study comparing quality of life (QOL) as assessed by patient-reported outcomes (PROs) in older (≥65 years) adults vs younger (55-64 years) undergoing allogeneic hematopoietic cell transplantation (HCT) for myelodysplastic syndromes (MDS). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Hematopoietic Cell Transplant
- What is being tested?
- ePRO survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 92 participants
- Where
- 6 sitesUnited States
- Study dates
- 23 Jul 2018to 15 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects previously enrolled on the 10-CMSMDS-1 protocol at participating centers will be assessed for eligibility into this protocol. Those meeting inclusion and exclusion criteria and consenting to participate will be enrolled.
Who may be able to join
- In order to be eligible to participate on this study, an individual must meet all of the following criteria:
- Underwent an allogeneic HCT for MDS on the 10-CMSMDS-1 protocol
- Prior consent to research and future contact by the CIBMTR
- Ability to provide RCI BMT protocol 17-ePRO signed and dated informed consent form (ICF)
- Age ≥55 years at time of transplant
- Fluent in English or Spanish
- Greater than 6 months post-HCT
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation on this study.
- No access to an internet browser or email account
- Within 6 months of first HCT for MDS on the 10-CMSMDS-1 protocol
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Ohio State University
Columbus, Ohio, 43210
Karmanos Cancer Institute
Detroit, Michigan, 48201
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Stanford University
Stanford, California, 94304
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: A Multi-Center, Phase II Cross-sectional Study Investigating Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes: a Companion Study to the CIBMTR 10-CMSMDS-1-Approved Expanded Access Study
This is a multi-center, Phase II, cross-sectional study comparing quality of life (QOL) as assessed by patient-reported outcomes (PROs) in older (≥65 years) adults vs younger (55-64 years) undergoing allogeneic hematopoietic cell transplantation (HCT) for myelodysplastic syndromes (MDS).
Read the detailed description
Transplant recipients who have met the inclusion and exclusion criteria and from participating study sites will be asked to complete an online consent and survey for the study. This survey is the patient-reported outcomes survey and will be used to assess quality of life. The survey results will then be compared by age group and by time post transplant, between 6 months and a year post transplant, 1 year to 3 years post transplant, and 3 years or more post transplant.
- Being tested
- ePRO survey
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePRO surveyBehavioural
An electronic patient reported outcomes survey will be completed by the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients between 55-64 years of age | Patients between 55-64 years who have had a transplant at the following time points:
* 6 months to 1 year ago
* 1 year to 3 years ago
* 3 years ago or more Receives: Behavioral: ePRO survey | |
| Patients 65+ years of age | Patients 65+ years of age who have had a transplant at the following time points:
* 6 months to 1 year ago
* 1 year to 3 years ago
* 3 years ago or more Receives: Behavioral: ePRO survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old.
The primary objective is to compare the change in long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old as measured by the assessment and when the assessment occurred at a post-HCT timepoint.
Measured: Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
Secondary outcomes (3)
Domain-specific QOL scores by age group as assessed by PROMIS measures.
Measured: 6 months-1 year post-HCT, 1 year - 3 years post-HCT, 3 years+ post-HCT
To explore the feasibility of electronic PROs (ePRO) collection in recipients ≥65 years old and to compare their compliance to that in recipients 55-64, by evaluating completion rate of the assessment by subjects by age group.
Measured: Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
To identify factors associated with poor compliance with reporting one-time single time ePRO measures in both age groups, by categorizing and quantifying reasons why subjects chose not to participate.
Measured: Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start23 Jul 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- Medical College of Wisconsin
- Responsible party
- Sponsor
- Investigators
- Bronwen E Shaw, MD, PhD, Principal investigator, Center for International Blood and Marrow Transplant Research (CIBMTR)/Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558386
- Sponsor's protocol ID
- 17-ePRO
- Status last verified
- Nov 2020
- First submitted
- 10 Apr 2018
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Phase II Cross-sectional Study Investigating Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes: a Companion Study to the CIBMTR 10-CMSMDS-1-Approved Expanded Access Study
- ClinicalTrials.gov ID
- NCT03558386
- Acronym / sponsor ID
- 17-ePRO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- Medical College of Wisconsin
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, Phase II, cross-sectional study comparing quality of life (QOL) as assessed by patient-reported outcomes (PROs) in older (≥65 years) adults vs younger (55-64 years) undergoing allogeneic hematopoietic cell transplantation (HCT) for myelodysplastic syndromes (MDS).
Detailed description
Transplant recipients who have met the inclusion and exclusion criteria and from participating study sites will be asked to complete an online consent and survey for the study. This survey is the patient-reported outcomes survey and will be used to assess quality of life. The survey results will then be compared by age group and by time post transplant, between 6 months and a year post transplant, 1 year to 3 years post transplant, and 3 years or more post transplant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients between 55-64 years of age | – | Behavioral: ePRO surveyPatients between 55-64 years who have had a transplant at the following time points: * 6 months to 1 year ago * 1 year to 3 years ago * 3 years ago or more |
| Patients 65+ years of age | – | Behavioral: ePRO surveyPatients 65+ years of age who have had a transplant at the following time points: * 6 months to 1 year ago * 1 year to 3 years ago * 3 years ago or more |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects previously enrolled on the 10-CMSMDS-1 protocol at participating centers will be assessed for eligibility into this protocol. Those meeting inclusion and exclusion criteria and consenting to participate will be enrolled.
Key inclusion criteria (7 listed)
- In order to be eligible to participate on this study, an individual must meet all of the following criteria:
- Underwent an allogeneic HCT for MDS on the 10-CMSMDS-1 protocol
- Prior consent to research and future contact by the CIBMTR
- Ability to provide RCI BMT protocol 17-ePRO signed and dated informed consent form (ICF)
- Age ≥55 years at time of transplant
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation on this study.
- No access to an internet browser or email account
- Within 6 months of first HCT for MDS on the 10-CMSMDS-1 protocol
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 |
|---|---|---|
| ePRO surveyAn electronic patient reported outcomes survey will be completed by the patient. | Behavioural | Patients 65+ years of age, Patients between 55-64 years of age |
Primary outcome
Long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old.
Time frame: Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
The primary objective is to compare the change in long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old as measured by the assessment and when the assessment occurred at a post-HCT timepoint.
3 secondary outcomes
Domain-specific QOL scores by age group as assessed by PROMIS measures.
Time frame: 6 months-1 year post-HCT, 1 year - 3 years post-HCT, 3 years+ post-HCT
To explore the feasibility of electronic PROs (ePRO) collection in recipients ≥65 years old and to compare their compliance to that in recipients 55-64, by evaluating completion rate of the assessment by subjects by age group.
Time frame: Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
To identify factors associated with poor compliance with reporting one-time single time ePRO measures in both age groups, by categorizing and quantifying reasons why subjects chose not to participate.
Time frame: Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- 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.
Bronwen E Shaw, MD, PhD principal investigator
Center for International Blood and Marrow Transplant Research (CIBMTR)/Medical College of Wisconsin
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes and Hematopoietic Cell Transplant, run by Center for International Blood and Marrow Transplant Research at 6 sites 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 7 inclusion and 3 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 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old. (time frame: Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2020.