Clinical trial NCT02081248: Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)
Official title: Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN #1205)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improve the Informed Consent Process
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Cancer Institute (NCI)
name: Blood and Marrow Transplant Clinical Trials Network
name: National Marrow Donor Program
First posted: 2014-03-07
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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 criteria: 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

Primary outcomes:
measure: Quality of Informed Consent Part A (QuIC-A) Score
timeFrame: Within 7 days of consent discussion
Secondary outcomes:
measure: Quality of Informed Consent Part B (QuIC-B) Score
timeFrame: Within 7 days of consent discussion
measure: Modified Deaconess Informed Consent Comprehension Test (DICCT)
timeFrame: WIthin 7 days of consent discussion
measure: REALM-R Score
timeFrame: Within 7 days of consent discussion
measure: Newest Vital Sign (NVS) Score
timeFrame: Within 7 days of consent discussion
measure: State Trait Anxiety Inventory (STAI) Score
timeFrame: Within 7 days of consent discussion
measure: Participant Satisfaction With Consent Process
timeFrame: Within 7 days of consent discussion
measure: Participant Information Location Time
timeFrame: Within 7 days of consent discussion
measure: Consent Rate on Parent Trial
timeFrame: Within 7 days of consent discussion
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida College of Medicine (Shands)
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: BMT Program at Northside Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Lawrence
country: United States
facility: University of Kansas
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University/Barnes Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Jewish Hospital BMT Program
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland/Case Western
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State/Arthur G. James Cancer Hospital
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
city: Milwaukee
country: United States
facility: The Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Center for International Blood and Marrow Transplant Research
name: Mary Horowitz, MD
role: STUDY_DIRECTOR
References:
citation: 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.