Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants

NCT04131062 | Completed

• 2 other identifiers: 2017-0334R01CA211723-03S1
• Study Type: interventional
• Target: 703
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to determine whether the Sage eConsent framework (presented using an electronic application) is non-inferior to traditional, paper-based, human-mediated consent-and therefore could be part of an acceptable population screening approach to identifying patients and others with actionable hereditary syndromes-and to increase basic knowledge about patients' informational needs about different aspects of genetic/omic screening. After receiving either 1) the traditional consenting approach, or 2) a consenting approach presented on an electronic tablet, the investigators will test for differences between these two arms in a variety of outcome measures including objective and perceived comprehension, time spent and informational needs, and enrollment decision, among others.

Conditions

Lynch Syndrome

Keywords

Inherited conditions; Biobank enrollment

Outcome Measures

Primary Outcomes (11)

• Mean objective comprehension: eConsent vs. control

  Objective comprehension quiz score measured using 10-item quiz (minimum = 0; maximum = 10; higher scores indicate greater comprehension)

  Immediately after consent decision

• Mean perceived comprehension: eConsent vs. control

  Subjective, self-reported comprehension measures using 8-item survey (minimum on each item = 1; maximum = 4; higher scores indicate greater perceived comprehension)

  Immediately after consent decision

• Mean perceived duration of consent process: eConsent vs. control

  Survey (1 item) (minimum on item = 1; maximum = 4; higher scores indicate shorter perceived duration)

  Immediately after consent decision

• Mean perceived ease of consent process: eConsent vs. control

  (minimum on item = 1; maximum = 4; higher scores indicate greater perceived ease)

  Immediately after consent decision

• Item-specific objective comprehension

  Item-specific responses to comprehension quiz (10 items) (six multiple choice items with four options each; four true/false items)

  Immediately after consent decision

• Item-specific perceived comprehension

  Item-specific perceived comprehension (8 items) (minimum on each item = 1; maximum = 4; higher scores indicate greater perceived comprehension)

  Immediately after consent decision

• Time spent considering each element of MyCode

  In-app click behavior (time spent per screen) (continuous measure of time in seconds; greater values indicate more time spent)

  Measured during consent

• Expressed informational needs for each element of MyCode

  In-app click behavior (rate of choosing to "learn more" per element) (more clicks indicate greater expressed informational needs)

  Measured during consent

• Sociodemographic variables

  Sociodemographic survey (17 items including discrete and continuous measure; "select all that apply" questions; and the ability to "prefer not to answer")

  Immediately after consent decision

• Actual duration of consent process

  Measured using stopwatch (paper arm) or app (iPad arm). Greater numbers indicate longer duration.

  Measured during consent

• MyCode enrollment decision

  Survey (1 item) (measured as "yes," "no," or "thinking (needs more time)"

  Immediately after consent process

Study Arms (2)

Control (no intervention)

NO INTERVENTION

Consented using the traditional, human-mediated consent process already in use for MyCode consenting.

Electronic Consent (iPad)

EXPERIMENTAL

Consented using the Sage eConsent framework, which presents participants with an iPad that describes MyCode and allows participants to choose to learn more information at various steps along the process.

Behavioral: Electronic Consent (iPad)

Interventions

Electronic Consent (iPad) BEHAVIORAL

Participants who receive the intervention will be consented using an electronic app presented via iPad and developed according to the Sage eConsent framework.

Electronic Consent (iPad)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• None

You may not qualify if:

• None

Sponsors & Collaborators

• Geisinger Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17821, United States

Location

Related Publications (1)

• Vogt-Yerem RL, Heck PR, Gjorgjieva T, Mestechkin R, Rosica D, Huynh A, Chabris CF, Kirchner HL, Wilbanks J, Doerr M, Wagner JK, Meyer MN. eConsent vs. Traditional Consent Among Prospective Biobank Participants: A Randomized Trial. medRxiv [Preprint]. 2025 Nov 2:2025.10.30.25339179. doi: 10.1101/2025.10.30.25339179.

  PMID: 41282898 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michelle N Meyer, PhD, JD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: One control arm (traditional, human-mediated consent) compared against one intervention arm (electronic-based consent using the Sage eConsent framework).

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 18, 2019
• Study Start: November 1, 2019
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be shared no later than publication of results, and will be available indefinitely.
• Access Criteria: The data will be available to anyone for general research use. It will be shared at CT.gov, Open Science Framework (OSF), or both.

Locations

US (1)