Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)
- Conditions
- Improve the Informed Consent Process
- Interventions
- Other: Consent Form Specific Format 1Other: Consent Form Specific Format 2
- Registration Number
- NCT02081248
- Lead Sponsor
- Medical College of Wisconsin
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
Not provided
N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Consent Consent Form Specific Format 1 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. Easy-to-Read Informed Consent Consent Form Specific Format 2 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.
- Primary Outcome Measures
Name Time Method Quality of Informed Consent Part A (QuIC-A) Score Within 7 days of consent discussion 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.
- Secondary Outcome Measures
Name Time Method Quality of Informed Consent Part B (QuIC-B) Score Within 7 days of consent discussion The Quality of Informed Consent Part B measures participants' perception of their understanding of cancer clinical trials to address 13 independent domains of informed consent. The QuIC-B is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of perceived understanding.
Modified Deaconess Informed Consent Comprehension Test (DICCT) WIthin 7 days of consent discussion The Modified Deaconess Informed Consent Comprehension Test (DICCT) uses semi-structured interviews to assess subject's understanding of the study for which they participated in an informed consent discussion. This modification of the DICCT has 11 items, each scored from 0 to 2 (0 = incorrect, 1 = partially correct, 2 = correct). The item scores are summed to produce a total score ranging from 0 to 22. A higher score indicates a higher level of comprehension.
REALM-R Score Within 7 days of consent discussion The Rapid Estimate of Adult Literacy in Medicine-Revised (REALM-R) is an 8-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy. The score is computed as the number of words out of 8 that the patient pronounces correctly.
Newest Vital Sign (NVS) Score Within 7 days of consent discussion The Newest Vital Sign is a screening tool that identifies patients at risk for low health literacy. It consists of a nutritional label accompanied by five questions about information on the label. The score is equal to the number of questions answered correctly.
Participant Satisfaction With Consent Process Within 7 days of consent discussion A 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. Seven questions are included, each scored on a five point Likert scale. The overall score is the average of the item scores, ranging from 1.0 to 5.0, with a higher score indicating a higher level of satisfaction.
State Trait Anxiety Inventory (STAI) Score Within 7 days of consent discussion The State Trait Anxiety Inventory (STAI) measures anxiety and distinguishes it from depressive syndromes. It has two subscales: the State Anxiety Scale evaluates the current state of anxiety, asking how respondents feel "right now," and Trait Anxiety Scale evaluating relatively stable aspects of "anxiety proneness". The STAI has 40 items, 20 items allocated to each subscale, with each item scored on a 4 point Likert scale. The subscale scores shown are averages of the items in the subscale ranging from 1.0 to 4.0, with a higher score indicating a greater level of anxiety.
Participant Information Location Time Within 7 days of consent discussion Participants are asked to identify select items within the consent document and the time taken to locate items is measured. Patients who were not able to identify a given section were assigned the maximum time allotted to find each section (180 seconds).
Consent Rate on Parent Trial Within 7 days of consent discussion The consent rate is the rate at which participants provided consent to participate in the parent trial.
Trial Locations
- Locations (23)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
The Jewish Hospital BMT Program
🇺🇸Cincinnati, Ohio, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Kansas
🇺🇸Lawrence, Kansas, United States
BMT Program at Northside Hospital
🇺🇸Atlanta, Georgia, 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
University Hospitals of Cleveland/Case Western
🇺🇸Cleveland, Ohio, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Washington University/Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
The Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
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
University of North Carolina Hospital at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States