Lynch SyndromeNCT04131062
Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants
A study testing Electronic Consent (iPad) in people with Lynch Syndrome, run by Geisinger Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- Electronic Consent (iPad)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 703 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 19 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- None
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial to Determine Whether eConsent is Non-Inferior to Standard Consent Among Prospective Biobank Participants
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.
Read the detailed description
The usual consent process for MyCode proceeds as follows: each day, trained MyCode consenters receive a list of patients who are eligible to be approached about MyCode and are scheduled to be seen that day in certain clinics in Geisinger's two-state catchment area. (Any Geisinger patient is eligible who has not previously enrolled in, or declined to enroll in, MyCode.) When an eligible patient arrives at the clinic, the consenter approaches them, confirms their identity, and then asks them if they would like to hear about MyCode. If they decline, the consenter thanks the patient for their time and the encounter is over. If the patient agrees, the consenter goes through a script that the MyCode team has developed from the written consent form that highlights the most important aspects of MyCode, including return of actionable results to participants and their primary care physicians, genetic privacy, and data sharing for research purposes. At the end of the script, the consenter invites and answers questions from the patient. Next, the consenter hands the patient the 7-page written consent form and asks if they would like a few minutes to review it. Finally, the consenter asks the patient whether they wish to enroll in MyCode or not and records their answer-Yes, No, or Thinking (i.e., the patient needs more time to consider)-into the patient's electronic health record.
In the present trial, patients are randomized at the individual level to receive either this usual consent or eConsent via iPad app. During the pilot phase of this trial, 11 Research Assistants (RAs) were trained on both MyCode consenting and on this trial's protocol. As per usual care, the RAs receive a daily list of MyCode-eligible patients scheduled to appear in clinic. And, as per usual care, the RAs approach the patient, confirm their identity, and ask if they wish to learn about MyCode. Those who do are then randomized to the usual care (paper) or eConsent (iPad) arm of the trial, according to whether the current time, as indicated by digital stopwatches, ends in an even or odd number. In the paper arm, the consent process proceeds as usual, with only two minor changes: 1) the RA uses the stopwatch to time the duration of the consent encounter (beginning from the moment they are randomized to the paper arm and ending when either the consent process is interrupted-e.g., because the patient is called back to the examination room-or when the consent process terminates with an enrollment decision (Yes, No, or Thinking); and 2) the RA uses a tracking sheet to record MyCode response rate (i.e., patients approached who did not want to hear about MyCode) and study attrition (e.g., consent process was interrupted). In the iPad arm, the RA hands the patient the iPad and explains that the interactive app will tell them all about MyCode. Patients reluctant to use an iPad are encouraged once to try, with the RA showing them that all that is involved is tapping, but patients who continue to resist are switched to the paper arm and this is noted on the tracking sheet. In the iPad arm, the RA also records whether the patient asks the RA any questions about MyCode and, as with the paper arm, when a patient declines to hear about MyCode and when the consent process is interrupted.
In both arms, patients are then asked to complete a survey, which serves as the primary source of data for the study. The survey is administered on paper in the paper arm and on iPad (via the Qualtrics platform) in the iPad arm. The eConsent app generates a random study ID number that is sent to Qualtrics, where the user's click behavior during the consent process (e.g., time spent on each screen and in total, whether the user clicked "learn more" on each page, (in)correct answers to teach-back questions) is anonymously combined with their survey responses. Survey questions are closed-end (true/false, multiple choice, Likert scale) and based on the Quality of Informed Consent and All of Us participant-provided information surveys.
This study is designed to be powered at 99% to detect an effect of modest size (half a point on the comprehension quiz), requiring 526 participants. Very high levels of power (here, 95% or 99%)-as opposed to the more standard benchmark power level of 80%-are desirable in tests of non-inferiority so that investigators can be as certain as possible that an inference of "no effect" is not a Type II error. In the very unlikely event that data collection proceeds much more slowly than it has in the pilot, the study retains 95% power to detect a one-half question effect with only 372 participants.
- Conditions
- Lynch Syndrome
- Being tested
- Electronic Consent (iPad)
- Keywords
- Inherited conditions, Biobank enrollment
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Consent (iPad)Behavioural
Participants who receive the intervention will be consented using an electronic app presented via iPad and developed according to the Sage eConsent framework.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Electronic Consent (iPad) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean objective comprehension: eConsent vs. control
Objective comprehension quiz score measured using 10-item quiz (minimum = 0; maximum = 10; higher scores indicate greater comprehension)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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: 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: 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")
Measured: Immediately after consent decision
Actual duration of consent process
Measured using stopwatch (paper arm) or app (iPad arm). Greater numbers indicate longer duration.
Measured: Measured during consent
MyCode enrollment decision
Survey (1 item) (measured as "yes," "no," or "thinking (needs more time)"
Measured: Immediately after consent process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Nov 2019
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One control arm (traditional, human-mediated consent) compared against one intervention arm (electronic-based consent using the Sage eConsent framework).
- Masking
- None (open label)
- Enrolment
- 703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Michelle N. Meyer, Geisinger Clinic
- Investigators
- Michelle N Meyer, PhD, JD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131062
- Sponsor's protocol ID
- 2017-0334
- Other IDs
- R01CA211723-03S1
- Status last verified
- Dec 2022
- First submitted
- 10 Oct 2019
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD (none of which includes identifiers) will be de-identified and shared. We will consider whether certain demographic variables need to be blurred to prevent identification of participants.
Publications
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 study within a study trial. NPJ Digit Public Health. 2026;1(1):9. doi: 10.1038/s44482-026-00013-x. Epub 2026 Apr 29.
PubMed 42078573Vogt-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.
PubMed 41282898
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Determine Whether eConsent is Non-Inferior to Standard Consent Among Prospective Biobank Participants
- ClinicalTrials.gov ID
- NCT04131062
- Acronym / sponsor ID
- 2017-0334
- Conditions
- Lynch Syndrome
- Keywords
- Inherited conditions, Biobank enrollment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 703 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The usual consent process for MyCode proceeds as follows: each day, trained MyCode consenters receive a list of patients who are eligible to be approached about MyCode and are scheduled to be seen that day in certain clinics in Geisinger's two-state catchment area. (Any Geisinger patient is eligible who has not previously enrolled in, or declined to enroll in, MyCode.) When an eligible patient arrives at the clinic, the consenter approaches them, confirms their identity, and then asks them if they would like to hear about MyCode. If they decline, the consenter thanks the patient for their time and the encounter is over. If the patient agrees, the consenter goes through a script that the MyCode team has developed from the written consent form that highlights the most important aspects of MyCode, including return of actionable results to participants and their primary care physicians, genetic privacy, and data sharing for research purposes. At the end of the script, the consenter invites and answers questions from the patient. Next, the consenter hands the patient the 7-page written consent form and asks if they would like a few minutes to review it. Finally, the consenter asks the patient whether they wish to enroll in MyCode or not and records their answer-Yes, No, or Thinking (i.e., the patient needs more time to consider)-into the patient's electronic health record.
In the present trial, patients are randomized at the individual level to receive either this usual consent or eConsent via iPad app. During the pilot phase of this trial, 11 Research Assistants (RAs) were trained on both MyCode consenting and on this trial's protocol. As per usual care, the RAs receive a daily list of MyCode-eligible patients scheduled to appear in clinic. And, as per usual care, the RAs approach the patient, confirm their identity, and ask if they wish to learn about MyCode. Those who do are then randomized to the usual care (paper) or eConsent (iPad) arm of the trial, according to whether the current time, as indicated by digital stopwatches, ends in an even or odd number. In the paper arm, the consent process proceeds as usual, with only two minor changes: 1) the RA uses the stopwatch to time the duration of the consent encounter (beginning from the moment they are randomized to the paper arm and ending when either the consent process is interrupted-e.g., because the patient is called back to the examination room-or when the consent process terminates with an enrollment decision (Yes, No, or Thinking); and 2) the RA uses a tracking sheet to record MyCode response rate (i.e., patients approached who did not want to hear about MyCode) and study attrition (e.g., consent process was interrupted). In the iPad arm, the RA hands the patient the iPad and explains that the interactive app will tell them all about MyCode. Patients reluctant to use an iPad are encouraged once to try, with the RA showing them that all that is involved is tapping, but patients who continue to resist are switched to the paper arm and this is noted on the tracking sheet. In the iPad arm, the RA also records whether the patient asks the RA any questions about MyCode and, as with the paper arm, when a patient declines to hear about MyCode and when the consent process is interrupted.
In both arms, patients are then asked to complete a survey, which serves as the primary source of data for the study. The survey is administered on paper in the paper arm and on iPad (via the Qualtrics platform) in the iPad arm. The eConsent app generates a random study ID number that is sent to Qualtrics, where the user's click behavior during the consent process (e.g., time spent on each screen and in total, whether the user clicked "learn more" on each page, (in)correct answers to teach-back questions) is anonymously combined with their survey responses. Survey questions are closed-end (true/false, multiple choice, Likert scale) and based on the Quality of Informed Consent and All of Us participant-provided information surveys.
This study is designed to be powered at 99% to detect an effect of modest size (half a point on the comprehension quiz), requiring 526 participants. Very high levels of power (here, 95% or 99%)-as opposed to the more standard benchmark power level of 80%-are desirable in tests of non-inferiority so that investigators can be as certain as possible that an inference of "no effect" is not a Type II error. In the very unlikely event that data collection proceeds much more slowly than it has in the pilot, the study retains 95% power to detect a one-half question effect with only 372 participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One control arm (traditional, human-mediated consent) compared against one intervention arm (electronic-based consent using the Sage eConsent framework).
| Arm | Type | Receives |
|---|---|---|
| Control (no intervention) | No intervention | –Consented using the traditional, human-mediated consent process already in use for MyCode consenting. |
| Electronic Consent (iPad) | Experimental | Behavioral: Electronic Consent (iPad)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Consent (iPad)Participants who receive the intervention will be consented using an electronic app presented via iPad and developed according to the Sage eConsent framework. | Behavioural | Electronic Consent (iPad) |
Primary outcome
Mean objective comprehension: eConsent vs. control
Time frame: Immediately after consent decision
Objective comprehension quiz score measured using 10-item quiz (minimum = 0; maximum = 10; higher scores indicate greater comprehension)
Mean perceived comprehension: eConsent vs. control
Time frame: Immediately after consent decision
Subjective, self-reported comprehension measures using 8-item survey (minimum on each item = 1; maximum = 4; higher scores indicate greater perceived comprehension)
Mean perceived duration of consent process: eConsent vs. control
Time frame: Immediately after consent decision
Survey (1 item) (minimum on item = 1; maximum = 4; higher scores indicate shorter perceived duration)
Mean perceived ease of consent process: eConsent vs. control
Time frame: Immediately after consent decision
(minimum on item = 1; maximum = 4; higher scores indicate greater perceived ease)
Item-specific objective comprehension
Time frame: Immediately after consent decision
Item-specific responses to comprehension quiz (10 items) (six multiple choice items with four options each; four true/false items)
Item-specific perceived comprehension
Time frame: Immediately after consent decision
Item-specific perceived comprehension (8 items) (minimum on each item = 1; maximum = 4; higher scores indicate greater perceived comprehension)
Time spent considering each element of MyCode
Time frame: Measured during consent
In-app click behavior (time spent per screen) (continuous measure of time in seconds; greater values indicate more time spent)
Expressed informational needs for each element of MyCode
Time frame: Measured during consent
In-app click behavior (rate of choosing to "learn more" per element) (more clicks indicate greater expressed informational needs)
Sociodemographic variables
Time frame: Immediately after consent decision
Sociodemographic survey (17 items including discrete and continuous measure; "select all that apply" questions; and the ability to "prefer not to answer")
Actual duration of consent process
Time frame: Measured during consent
Measured using stopwatch (paper arm) or app (iPad arm). Greater numbers indicate longer duration.
MyCode enrollment decision
Time frame: Immediately after consent process
Survey (1 item) (measured as "yes," "no," or "thinking (needs more time)"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Derived from this study: PubMed 42078573Vogt-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 study within a study trial. NPJ Digit Public Health. 2026;1(1):9. doi: 10.1038/s44482-026-00013-x. Epub 2026 Apr 29.
- Derived from this study: PubMed 41282898Vogt-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.
- Individual participant dataSharing planned: Yes. All collected IPD (none of which includes identifiers) will be de-identified and shared. We will consider whether certain demographic variables need to be blurred to prevent identification of participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle N Meyer, PhD, JD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Consent (iPad) in people with Lynch Syndrome, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean objective comprehension: eConsent vs. control (time frame: Immediately after consent decision). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04131062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.