Clinical Trial 19621

Cancer Type:

Study Type: Other
Phase of Study: Phase II

  • Joseph Pidala


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 Resource for Clinical Investigation in Blood and Marrow Transplantation (RCI BMT) PROTOCOL 17-ePRO


All participants previously enrolled on the 10-CMSMDS-1 protocol will be assessed for eligibility into this protocol. This is a cross-sectional study collecting Patient-reported Outcomes (PROs) at a single time point post-HCT.


The primary objective is to compare long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients >/= 65 years old to those 55-64 years old. The hypothesis to be tested is that older recipients (>/=65) will have similar post-HCT QOL across time points, as assessed by patient reported outcomes (PROs), as younger recipients (55-64). Secondary: a) To describe the QOL deficits by domain in post-HCT recipients and to identify factors associated with poorer QOL in both age groups. b) 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. c) To identify factors associated with poor compliance with reporting ePRO in both age groups.

Inclusion Criteria

  • Underwent an allogeneic Hematopoietic cell transplantation (HCT) for Myelodysplastic Syndromes (MDS) on the 10-CMSMDS-1 protocol.
  • Prior consent to research and future contact by the Center for International Blood and Marrow Transplant Research (CIBMTR).
  • Ability to provide Resource for Clinical Investigation in Blood and Marrow Transplantation (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

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