Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)
Improve the Informed Consent Process
Bottom Line
View on ClinicalTrials.gov: NCT02081248 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Consent Form Specific Format 1 (Other); Consent Form Specific Format 2 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Informed Consent Part A (QuIC-A) Score |
81.8; 80.5 | 0.37 |
| SECONDARY Quality of Informed Consent Part B (QuIC-B) Score |
98.2; 96.4 | 0.39 |
| SECONDARY Modified Deaconess Informed Consent Comprehension Test (DICCT) |
15; 15 | 0.17 |
| SECONDARY REALM-R Score |
15; 17; 62; 69; 21; 14 | — |
| SECONDARY Newest Vital Sign (NVS) Score |
11; 16; 53; 52; 13; 18 | — |
| SECONDARY State Trait Anxiety Inventory (STAI) Score |
2.5; 2.5; 2.4; 2.3 | 0.21 |
| SECONDARY Participant Satisfaction With Consent Process |
4.2; 4.1 | 0.80 |
| SECONDARY Participant Information Location Time |
22; 30; 15; 20; 20; 20 | 0.73 |
| SECONDARY Consent Rate on Parent Trial |
2; 3; 13; 10; 22; 25 | 1.00 |
Summary
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:
- Adult patients (≥ 18 years)
- Speaking and reading proficiency in English (as most of this study's instruments have not been translated and validated in languages other than English)
- Willing and able to provide informed consent
- Stated willingness to comply with study procedures and reporting requirements
Exclusion Criteria: N/A
Data sourced from ClinicalTrials.gov (NCT02081248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.