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

NCT ID: NCT02081248

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-08-03

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.

Conditions

Improve the Informed Consent Process

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard Consent

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.

Group Type: ACTIVE_COMPARATOR

Consent Form Specific Format 1

Intervention Type: OTHER

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.

Easy-to-Read Informed Consent

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.

Group Type: EXPERIMENTAL

Consent Form Specific Format 2

Intervention Type: OTHER

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.

Interventions

Consent Form Specific Format 1

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.

Intervention Type: OTHER

Consent Form Specific Format 2

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

Sponsor Role: collaborator

National Marrow Donor Program

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Horowitz, MD

Role: STUDY_DIRECTOR

Center for International Blood and Marrow Transplant Research

Locations

City of Hope National Medical Center

Duarte, California, United States

University of Florida College of Medicine (Shands)

Gainesville, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

BMT Program at Northside Hospital

Atlanta, Georgia, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Kansas

Lawrence, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University/Barnes Jewish Hospital

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of North Carolina Hospital at Chapel Hill

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

The Jewish Hospital BMT Program

Cincinnati, Ohio, United States

University Hospitals of Cleveland/Case Western

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State/Arthur G. James Cancer Hospital

Columbus, Ohio, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29679770 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2U10HL069294-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5U24CA076518

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BMTCTN1205

Identifier Type: -

Identifier Source: org_study_id