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Study of Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT03558386
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : December 2, 2020
Sponsor:
Collaborator:
Medical College of Wisconsin
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

Brief 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).

Condition or disease Intervention/treatment
Myelodysplastic Syndromes Hematopoietic Cell Transplant Behavioral: ePRO survey

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.

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : July 23, 2018
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019


Group/Cohort Intervention/treatment
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
Behavioral: ePRO survey
An electronic patient reported outcomes survey will be completed by the patient.

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
Behavioral: ePRO survey
An electronic patient reported outcomes survey will be completed by the patient.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

In order to be eligible to participate on this study, an individual must meet all of the following criteria:

  1. Underwent an allogeneic HCT for MDS on the 10-CMSMDS-1 protocol
  2. Prior consent to research and future contact by the CIBMTR
  3. Ability to provide RCI BMT protocol 17-ePRO signed and dated informed consent form (ICF)
  4. Age ≥55 years at time of transplant
  5. Fluent in English or Spanish
  6. Greater than 6 months post-HCT

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation on this study.

  1. No access to an internet browser or email account
  2. Within 6 months of first HCT for MDS on the 10-CMSMDS-1 protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558386


Locations
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United States, California
Stanford University
Stanford, California, United States, 94304
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
Medical College of Wisconsin
Investigators
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Principal Investigator: Bronwen E Shaw, MD, PhD Center for International Blood and Marrow Transplant Research (CIBMTR)/Medical College of Wisconsin
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Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT03558386    
Other Study ID Numbers: 17-ePRO
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms