Trial record 2 of 2 for:    BMT CTN 0901

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Medical College of Wisconsin
Sponsor:
Collaborators:
Blood and Marrow Transplant Clinical Trials Network
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT02081248
First received: October 30, 2013
Last updated: March 3, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
To Improve the Informed Consent Process.
Other: Consent Form Specific Format 1
Other: Consent Form Specific Format 2
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN #1205)

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Comprehension [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Secondary Comprehension [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Quality of Informed Consent (part B) measures actual subjects understanding of cancer clinical trials to address 13 independent domains of informed consent.

  • Secondary Comprehension [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Deaconess Informed Consent Comprehension Test (DICCT) uses semi-structured interviews to assess subject's understanding of 8 core elements of disclosure for the study they have agreed to participate in.

  • State Anxiety [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Trait Anxiety Inventory (STAI) measures anxiety and distinguishes it from depressive syndromes.

  • Satisfaction [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Short study specific questionnaire and selected questions from the Quality of Informed Consent (QuIC) supplement questionnaire will query participants about their overall satisfaction with the consent process, helpfulness of information provided, and comprehension of key study-specific elements of treatment.

  • Information Location [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Subjects are asked to identify select items within the consent document and the time taken to locate items is measured.

  • Health Literacy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Rapid Estimate of Adult Literacy in Medicine (REALM) is a medical-word recognition and pronunciation test to determine subject's grade-equivalent reading level.

  • Health Literacy [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The Newest Vital Sign (NVS) uses an ice cream container nutrition label to measure numeracy and reading comprehension.


Estimated Enrollment: 160
Study Start Date: December 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: 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.
Experimental: 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.
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.

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.

Note: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Note: Enrollment on the BMT CTN 0901 trial (NCT01339910) was closed to further accrual on April 18, 2014.

Additional inclusion criterion 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081248

Contacts
Contact: Heather Wittsack 301-251-1161 hwittsack@emmes.com
Contact: Adam Mendizabal 301-251-1161 amendizabal@emmes.com

  Show 25 Study Locations
Sponsors and Collaborators
Medical College of Wisconsin
Blood and Marrow Transplant Clinical Trials Network
Investigators
Study Director: Mary Horowitz, MD Center for International Blood and Marrow Transplant Research
  More Information

Additional Information:
No publications provided

Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02081248     History of Changes
Other Study ID Numbers: BMTCTN1205, 2U10HL069294-11
Study First Received: October 30, 2013
Last Updated: March 3, 2015
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on March 26, 2015