RECRUITING

Implement and Test Visual Consent Template and Process

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators plan to conduct a stepped wedge randomized control trial to implement and test the consent template and process in three studies. Randomization will occur at the research coordinator/research team level. Each participating research team member will begin in the standard consent arm of the study. Subsequently, they will be randomized to the visual key information page arm at staggered time points to undergo training and begin using the visual key information page with patients who are eligible for the selected research study.

Official Title

Implement and Test Visual Consent Template and Process

Quick Facts

Study Start:2025-03-10
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06804837

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
  2. * Participant is willing and able to comply with study procedures based on the judgment of the investigator.
  3. * Age ≥ 18 years at the time of consent.
  4. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
  5. * Consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
  6. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  7. * Washington University:
  8. * Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies (WeSHARE)
  9. * Participants of the Knight Alzheimer Disease Research Center.
  10. * Participants with available results from an Alzheimer Disease blood biomarker test.
  11. * Participants who agreed to be contacted for additional research studies.
  12. * University of Utah:
  13. * Huntsman Cancer Institute Total Cancer Care
  14. * Participants who have been diagnosed with any type of tumor or cancer.
  15. * Participants with genetic predispositions or family history of cancer or tumors.
  16. * Participant volunteers willing to share samples and data for research.
  17. * Research staff/coordinators of one of the three participating trials at Washington University, University of Utah, or University of North Carolina at Chapel Hill.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mary Politi, Ph.D.
CONTACT
314-747-1967
mpoliti@wustl.edu
Krista Cooksey, B.A.
CONTACT
314-747-5657
kcooksey@wustl.edu

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599
United States
University of Utah Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-03-10
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Informed consent
  • Key information
  • Common Rule
  • Research ethics

Additional Relevant MeSH Terms

  • Cancer
  • Alzheimer Disease