NCT02081248|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
198
1 country
23
Study Start
December 2013
Actual (reported)Primary Completion
August 3, 2016
Actual (reported)Study Completion
August 3, 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 3, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2013
Actual (reported)December 2013
Actual (reported)March 7, 2014
Actual (reported)August 3, 2016
Actual (reported)August 3, 2016
Actual (reported)June 1, 2018
Actual (reported)Quality of Informed Consent Part A (QuIC-A) Score
The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension.
Within 7 days of consent discussion
Quality of Informed Consent Part B (QuIC-B) Score
Within 7 days of consent discussion
Modified Deaconess Informed Consent Comprehension Test (DICCT)
WIthin 7 days of consent discussion
REALM-R Score
Within 7 days of consent discussion
Newest Vital Sign (NVS) Score
Within 7 days of consent discussion
State Trait Anxiety Inventory (STAI) Score
Within 7 days of consent discussion
This arm will receive the Consent Form Specific Format 1 'standard consent'. The standard consents are already approved and used for the BMT CTN 0901, 1101, 1203, and 1301 trials.
This arm will receive the Consent Form Specific Format 2 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent (ETRIC) is the newly approved consent.
The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
City of Hope National Medical Center
Duarte, California, 91010, United States
University of Florida College of Medicine (Shands)
Gainesville, Florida, 32610-0277, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33624, United States
Emory University
Atlanta, Georgia, 30322, United States
BMT Program at Northside Hospital
Atlanta, Georgia, 30342, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Spellecy R, Tarima S, Denzen E, Moore H, Abhyankar S, Dawson P, Foley A, Gersten I, Horwitz M, Idossa L, Joffe S, Kamani N, King R, Lazaryan A, Morris L, Horowitz MM, Majhail NS. Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study. Biol Blood Marrow Transplant. 2018 Oct;24(10):2145-2151. doi: 10.1016/j.bbmt.2018.04.014. Epub 2018 Apr 18.
Mary Horowitz, MD
Center for International Blood and Marrow Transplant Research
198 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2013
First Posted
March 7, 2014
Study Start
December 2013
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
University of Kansas
Lawrence, Kansas, 66045, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of North Carolina Hospital at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
The Jewish Hospital BMT Program
Cincinnati, Ohio, 45236, United States
University Hospitals of Cleveland/Case Western
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State/Arthur G. James Cancer Hospital
Columbus, Ohio, 43210, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-3309, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506-9162, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Primary Completion
August 3, 2016
Actual (reported)Study Completion
August 3, 2016
Actual (reported)Last Updated
December 8, 2022
Results First Posted
June 1, 2018
Record last verified: 2022-12
Findings will be published in a manuscript.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
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