Informed Consent
Conditions
Brief summary
The purpose of this study is to determine the feasibility of implementing the chatbot "CoCo" in the IC process for research studies. We hypothesize that implementing a chatbot into the IC process will facilitate accurate information delivery and enhance participant comprehension and process satisfaction compared to traditional remote consent methods.
Detailed description
Primary Objectives: • To determine the feasibility of implementing a chatbot-facilitated remote informed consent (IC) process. Secondary Objectives * To identify determinants of patient acceptance and usage of the chatbot. * To determine the accuracy and completeness of information delivered via the chatbot. * To determine the quality of the chatbot-facilitated remote IC process. * To determine the feasibility of using the chatbot for patient eligibility verification.
Interventions
OTHERCoCo Chatbot
A patient-facing chatbot designed to obtain informed consent
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to understand and willingness to provide informed consent. * Age ≥18 years. * Patients whose preferred language is English. * Patients who are being considered for enrollment in selected clinical research studies. Phase I will be initiated using the Clearinghouse protocol PA11-0852, a non-interventional biomarker study.
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTFunda Meric-Bernstam, MD
PRINCIPAL_INVESTIGATORFunda Meric-Bernstam, MD
UT MD Anderson
Outcome results
None listed