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BMTCTN 1205   |   14-326
A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia and A Multi-Center, Phase III, Randomized Trial of Reduced Intensity Conditioning (RIC) and Transplantation of Double Unrelated Umbilical Cord Blood (dUCB) versus HLA-Haploidentical Related Bone Marrow for Patients with Hematologic Malignancies

Disease(s)
Blood & Marrow Transplant (BMT)
Hematologic Malignancy
Hospital(s)
Main Campus
Phase(s)
Phase 3
Stage(s)
Type(s)
Therapeutic
Drug(s)

Contact Information
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Description
Primary
  1. Primary objective of the randomized study is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between patients randomized to the ETRIC versus the standard consent arms.
secondary
  1. to compare the following measures between the two arms: (1) subjective comprehension scores on the Quality of Informed Consent (part B) instrument and the modified Deaconess Informed Consent Comprehension Test instrument, (2) state anxiety scores on State Trait Anxiety Inventory instrument, (3) satisfaction scores, (4) time taken for information location, and (5) patient consent rates on parent clinical trials.

Inclusion Criteria
  1. Inclusion and exclusion criteria for the ETRIC randomized study will be the same as theeligibility criteria for the BMT CTN 0901 and 1101 studies. Both studies are restricted to adultpatients (≥ 18 years). Additional inclusion criterion specific for the ETRIC study will include:
    • Speaking and reading proficiency in English (as most of this study�s instruments have not been translated and validated in languages other than English).
    • Willing and able to provide informed consent.
    • Stated willingness to comply with study procedures and reporting requirements.

Exclusion Criteria
Exclusion Criteria Not Available

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