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

Active:	No
Cancer Type:	Cancer-Related Syndrome Hematopoietic Malignancies Hodgkin Lymphoma Leukemia Lymphoma Myelodysplastic Syndromes (MDS)	NCT ID:	NCT02081248
Trial Phases:		Protocol IDs:	BMTCTN1205 (primary) 2U10HL069294-11
Eligibility:	18 Years and older, Male and Female	Study Type:	Health services research
Study Sponsor:	Medical College of Wisconsin
NCI Full Details:	http://clinicaltrials.gov/show/NCT02081248

Summary

The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and
(2) Evaluation Study to understand barriers to implementation of ETRIC.

Objectives

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.

Treatment Sites in Georgia

Blood and Marrow Transplant Program at Northside Hospital Cancer Institute
5670 Peachtree Dunwoody Road
Suite 1000
Atlanta, GA 30342
404-255-1930
www.bmtga.com

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