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Completed

NCT Number: NCT03558386

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

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).

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hematopoietic Cell Transplant Hemic and Lymphatic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ePRO survey

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Collaborators

  • Medical College of Wisconsin

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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