Details
Title 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
IRB CTN1205
CC 14-326
Hospital Main Campus
Phase Phase 3
Disease Blood & Marrow Transplant (BMT), Hematologic Malignancy
Description
Primary ObjectiveTo 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 ObjectivesTo 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
Inclusion and exclusion criteria for the ETRIC study will be the same as the eligibility criteria for the BMT CTN 1101 and 1203 studies. Additional inclusion criterion specific for the ETRIC study will include:- Adult patients (≥ 18 years)
- Speaking and reading proficiency in English
- Willing and able to provide informed consent for the ETRIC study
- Stated willingness to comply with study procedures and reporting requirements
