Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)

A two-arm, randomized study will be conducted in patients about to undergo consent discussion
for participation in two large, multicenter BMT CTN clinical trials. Once they agree to
participate in this Easy-to-Read Informed Consent (ETRIC) study, they will go through the
consent process for the parent trial using either a standard or the ETRIC consent form. The
content of both forms will be similar but the ETRIC form will incorporate a two-column format
with specific attention towards enhanced readability and processability. Following the
consent discussion for the BMT CTN parent trial, patients will complete assessments of health
literacy, comprehension of the parent trial and satisfaction and anxiety related to the
consent process. These assessments will be completed within 7 business days of the consent
discussion of the parent trial.

Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on
April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May
13, 2016.

Inclusion and exclusion criteria for the ETRIC randomized study will be the same as the
eligibility criteria for the BMT CTN parent studies. Please refer to BMTCTN0901
(NCT01339910) Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or
Myelodysplastic Syndrome, BMTCTN1101 (NCT01597778) Double Cord Versus Haploidentical,
BMTCTN1203 (NCT02208037) Novel Approaches for Graft-versus-Host Disease Prevention Compared
to Contemporary Controls, and BMTCTN1301 (NCT02345850) Calcineurin Inhibitor-Free
Interventions for Prevention of Graft-versus-Host Disease for detailed eligibility
criteria.

Notes: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on
April 18, 2014. Enrollment on the BMT CTN 1203 trial (NCT02208037) completed accrual on May
13, 2016.

Additional inclusion criteria specific for the ETRIC study will include:

1. Adult patients (≥ 18 years)

2. Speaking and reading proficiency in English (as most of this study's instruments have
not been translated and validated in languages other than English)

3. Willing and able to provide informed consent

4. Stated willingness to comply with study procedures and reporting requirements

Exclusion Criteria: N/A