A Study of an Easy-to-Read Informed Consent for Bone Marrow Transplant Clinical Trials
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-000929
NCT ID: NCT02081248
Sponsor Protocol Number: BMTCTN1205
About this study
The purpose of this study is to evaluate the effectiveness of an easy to read informed consent form compared to the standard consent, and to understand any barriers to the use of the new form.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- 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
- Further inclusion /exclusion criteria for the ETRIC randomized study will be the same as the eligibility criteria for the BMT CTN parent studies
- Refer to 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Mark Litzow, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available