Identifying Best Approach in Improving Quality of Life and Survival After a Donor Stem Cell Transplant in Older, Medically Infirm, or Frail Patients With Blood Diseases

Overview

About this study

The purpose of this study is to compare the effectiveness of supportive and palliative care, a clinical multi-modal program, or a combined approach versus usual care only (UCO) to determine the winning arm in improving HRQOL (Day-90 FACT-BMT scores) for vulnerable recipients of allogeneic Hematopoietic Cell Transplantation (HCT)

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Vulnerable patients as defined by one or more of the following criteria:
    • Age 65 years or older;
    • Having HCT-CI scores of ≥ 3 (for patients that could be 20 years old and older);
    • Having frailty as determined by walk speed of < 0.8 m/s using 4-meter walk test (for patients that could be 40 years old and older).
  • Patients considered or referred for allogeneic HCT to treat a hematological malignant or non-malignant disease.
  • Able to speak and read English – interaction with the interventionist trainer and endpoint measurement must occur in English.
  • Willing and able to provide informed consent.
  • Stated willingness to comply with study procedures and reporting requirements.
  • Planned allogeneic HCT within 3 weeks – all types of donors and all sorts of conditioning regimens are allowed. Patients with suspected active disease (relatively old disease staging or relatively old intervention) or significant comorbidity (e.g., suspicious untreated pulmonary nodules) based on prior evaluations, that could delay the transplant would be considered for enrollment within a tighter window (10-14 days before allogeneic HCT) to allow for completed pre-HCT work-up evaluations that would confirm readiness to proceed with transplant.
  • Able to exercise at low to moderate intensity.
  • Adequate cardiopulmonary reserve, as judged by data from the patient’s electronic medical record as to whether a patient could walk up one flight of stairs, no need for supplemental oxygen, and/or physician judgment.

Exclusion Criteria:

  • Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence. Information on prior falls and other recent orthopedic or neurologic problems will be used to make judgment about protocol eligibility.
  • Participation in another intervention clinical trial with HRQOL as a primary endpoint.
  • Planned donor lymphocyte infusion (DLI) within 90 days post-transplant.
  • Planned anti-cytotoxic therapies, other than tyrosine kinase inhibitors or single-agent monoclonal antibody, or FLT-3 inhibitors within 90 days of post-transplant unless pre-approved by the protocol Principal Investigator (PI).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hassan Alkhateeb, M.D.

Open for enrollment

Contact information:

Jennifer Hull

(507) 422-4820

Hull.Jennifer2@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20523997

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