NCT07756515

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
60mo left

Started Jan 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2028

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2031

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Informed Consent

Outcome Measures

Primary Outcomes (1)

  • Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (1)

Phase I Feasibility Cohort: Remote IC Process for Non-Therapeutic Studies

EXPERIMENTAL

All participants will be provided with an abbreviated informed consent form describing this study and providing sufficient information for patients to make an informed decision regarding participation.

Other: CoCo Chatbot

Interventions

CoCo ChatbotOTHER

A patient-facing chatbot designed to obtain informed consent

Phase I Feasibility Cohort: Remote IC Process for Non-Therapeutic Studies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

Study Officials

  • Funda Meric-Bernstam, MD

    UT MD Anderson

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Funda Meric-Bernstam, MD

CONTACT

(713) 794-1226fmeric@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 10, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 17, 2028

Study Completion (Estimated)

December 17, 2031

Last Updated

August 10, 2026

Record last verified: 2026-08

Locations

US(1)