Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)
Cancer-Related Syndrome
Hematopoietic Malignancies
Hodgkin Lymphoma
Leukemia
Lymphoma
Myelodysplastic Syndromes (MDS)
18 Years and older, Male and Female
BMTCTN1205 (primary)
2U10HL069294-11
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.
Eligibility
- 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
Treatment Sites in Georgia
5670 Peachtree Dunwoody Road
Suite 1000
Atlanta, GA 30342
404-255-1930
www.bmtga.com
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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