CancerNCT07293520
Improving Consent Experiences in Clinical Trials
A study testing Standard Consent Form and Visual Key Information (VKI) page in people with Cancer, run by Washington University School of Medicine.
Trial summary
This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Standard Consent Form and Visual Key Information (VKI) page
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2025to 31 Dec 2026
- 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
Patient Eligibility Criteria:
- Patient must be 18 years or older
- Patients must be English-speaking
- Able to understand an IRB-approved written consent document
- Must go through the consent process for one of the parent studies
Research Team Eligibility Criteria:
- Member of a parent study research team
- Engaged in the study consent processes, including creating and reviewing consents or enrolling participants
About this study
Official title: Improving Consent Experiences in Clinical Trials at Siteman Cancer Center
This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process.
- Conditions
- Cancer
- Being tested
- Standard Consent Form, Visual Key Information (VKI) page
- Keywords
- Informed Consent, Key information, Research Ethics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Consent FormBehavioural
The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.
Visual Key Information (VKI) pageBehavioural
A VKI page will be designed for each parent study based on study materials and current consent document. The VKI will be implemented in the consent material for the study.
| Study group | Role | What they receive |
|---|---|---|
| Standard consent forms | Active comparator | The approved standard consent form will be used during the consent processes. Receives: Behavioral: Standard Consent Form |
| Standard consent forms with a visual key information (VKI) page | Experimental | The approved standard consent form with a VKI page will be used during the consent processes. Receives: Behavioral: Standard Consent Form; Behavioral: Visual Key Information (VKI) page |
| Research Team Members | Experimental | Members of the parent study's research team will complete the research team survey to assess opinions on consent process. Receives: Behavioral: Standard Consent Form; Behavioral: Visual Key Information (VKI) page |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's knowledge of consent
Knowledge of consent will be measured by patient's responses to 6-items on the patient consent experience survey. The 6-items are customized for each parent study and have three answers for patient to choose: true, false, and unsure. Responses will be reported via descriptive statistics and between group differences will be examined via chi-square tests.
Measured: Time of consent completion for parent study (day 1)
Patient's anxiety about enrolling
Anxiety about enrolling will be captured by patient's answers to a single item on the patient consent experience survey adapted from the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The item is measured by a 5-point Likert scale as follows: Not at all, A little, Somewhat, A lot, and Extremely. Responses be will scored as appropriate for the validated measure and between group differences will be examined via t-tests.
Measured: Time of consent completion for parent study (day 1)
Secondary outcomes (3)
Patient's trust in information
Patient's trust in information will be measured by a single-item on the patient consent experience survey adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The item is a 5-point scale with answers as follows: Not at all, Slightly, Moderately, Very, and Extremely. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests.
Measured: Time of consent completion for parent study (day 1)
Patient's perceptions of patient centered care
Perception of patient-centered care (PCC) will be measured by three items on the patient consent experience survey which are adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The items are a 4-point scale as follows: Always, Usually, Sometimes, and Never. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests.
Measured: Time of consent completion for parent study (day 1)
Parent study enrollment rates
Enrollment rates will be measured by total number of patients enrolled in each parent study. Responses will be reported via descriptive statistics and between group differences will be examined via t-tests.
Measured: Completion of enrollment (estimated total time is 9-13 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start25 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary C Politi, PhD, Principal investigator, Washington University in St. Louis School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293520
- Sponsor's protocol ID
- 202511065
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Consent Experiences in Clinical Trials at Siteman Cancer Center
- ClinicalTrials.gov ID
- NCT07293520
- Acronym / sponsor ID
- 202511065
- Conditions
- Cancer
- Keywords
- Informed Consent, Key information, Research Ethics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Dec 2025 (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.
This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard consent forms | Active comparator | Behavioral: Standard Consent FormThe approved standard consent form will be used during the consent processes. |
| Standard consent forms with a visual key information (VKI) page | Experimental | Behavioral: Standard Consent Form, Behavioral: Visual Key Information (VKI) pageThe approved standard consent form with a VKI page will be used during the consent processes. |
| Research Team Members | Experimental | Behavioral: Standard Consent Form, Behavioral: Visual Key Information (VKI) pageMembers of the parent study's research team will complete the research team survey to assess opinions on consent process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Standard Consent FormThe IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies. | Behavioural | Research Team Members, Standard consent forms, Standard consent forms with a visual key information (VKI) page |
| Visual Key Information (VKI) pageA VKI page will be designed for each parent study based on study materials and current consent document. The VKI will be implemented in the consent material for the study. | Behavioural | Research Team Members, Standard consent forms with a visual key information (VKI) page |
Primary outcome
Patient's knowledge of consent
Time frame: Time of consent completion for parent study (day 1)
Knowledge of consent will be measured by patient's responses to 6-items on the patient consent experience survey. The 6-items are customized for each parent study and have three answers for patient to choose: true, false, and unsure. Responses will be reported via descriptive statistics and between group differences will be examined via chi-square tests.
Patient's anxiety about enrolling
Time frame: Time of consent completion for parent study (day 1)
Anxiety about enrolling will be captured by patient's answers to a single item on the patient consent experience survey adapted from the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The item is measured by a 5-point Likert scale as follows: Not at all, A little, Somewhat, A lot, and Extremely. Responses be will scored as appropriate for the validated measure and between group differences will be examined via t-tests.
3 secondary outcomes
Patient's trust in information
Time frame: Time of consent completion for parent study (day 1)
Patient's perceptions of patient centered care
Time frame: Time of consent completion for parent study (day 1)
Parent study enrollment rates
Time frame: Completion of enrollment (estimated total time is 9-13 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mary C Politi, PhD principal investigator
Washington University in St. Louis School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Standard Consent Form and Visual Key Information (VKI) page in people with Cancer, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Patient's knowledge of consent (time frame: Time of consent completion for parent study (day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2025.