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NCT Number: NCT07756515

Chatbot Implementation In The Clinical Informed Consent Process

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.

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Key information

Conditions

Informed Consent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT MD Anderson

Houston, Texas, 77030, United States

Location contact

Funda Meric-Bernstam, MD

CONTACT

[email protected]

713-794-1226

Funda Meric-Bernstam, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoCo Chatbot

Other

A patient-facing chatbot designed to obtain informed consent

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Funda Meric-Bernstam, MD

CONTACT

[email protected]

(713) 794-1226

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2031
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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