Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/3/2018 |
Start Date: | December 2013 |
End Date: | August 3, 2016 |
Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN #1205)
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.
Evaluation Study to understand barriers to implementation of ETRIC.
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.
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
We found this trial at
23
sites
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 410-955-8143
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1600 SW Archer Rd # M509
Gainesville, Florida 32610
Gainesville, Florida 32610
Phone: 352-273-8022
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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101 Manning Dr
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
(919) 966-4131
University of North Carolina Hospital at Chapel Hill The UNC Health Care System is a...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
Phone: 626-256-4673
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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2160 South 1st Avenue
Maywood, Illinois 60153
Maywood, Illinois 60153
(888) 584-7888
Phone: 708-327-3300
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-805-0700
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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