Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)
|ClinicalTrials.gov Identifier: NCT02081248|
Recruitment Status : Active, not recruiting
First Posted : March 7, 2014
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment|
|Improve the Informed Consent Process||Other: Consent Form Specific Format 1 Other: Consent Form Specific Format 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN #1205)|
|Actual Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||September 2018|
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.
- Comprehension [ Time Frame: Day 1 ]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 Comprehension of the Quality of Informed Consent (part B) [ Time Frame: Day 1 ]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 of the Deaconess Informed Consent Comprehension Test (DICCT) [ Time Frame: Day 1 ]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 ]Trait Anxiety Inventory (STAI) measures anxiety and distinguishes it from depressive syndromes.
- Satisfaction [ Time Frame: Day 1 ]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 ]Subjects are asked to identify select items within the consent document and the time taken to locate items is measured.
- Rapid Estimate of Adult Literacy in Medicine (REALM) [ Time Frame: Day 1 ]Health Literacy will be assessed using the REALM, a medical-word recognition and pronunciation test to determine subject's grade-equivalent reading level.
- Health Literacy of the Newest Vital Sign (NVS) [ Time Frame: Day 1 ]The Newest Vital Sign (NVS) uses an ice cream container nutrition label to measure numeracy and reading comprehension.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081248
Show 23 Study Locations
|Study Director:||Mary Horowitz, MD||Center for International Blood and Marrow Transplant Research|