RECRUITING

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

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 purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.

Official Title

Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening in Hospitals Serving Diverse Patients

Quick Facts

Study Start:2024-05-15
Study Completion:2028-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06192511

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. * Adult (\> 18 years)
  2. * English, Spanish or Arabic speaking
  3. * Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital
  1. * Parents of infants who are born pre-term (\< 37 weeks gestation)
  2. * Parents of infants in the Neonatal Intensive Care Unit
  3. * Parents of infants being put up for adoption or in situations where legal guardianship is unknown at the time of birth

Contacts and Locations

Study Contact

Erin Johnson, PhD
CONTACT
801-587-8578
erin.p.johnson@hsc.utah.edu
Valerie Joseph
CONTACT
801-587-2249
valerie.joseph@hsc.utah.edu

Principal Investigator

Erin Rothwell, MD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
United States
University of Utah, Department of Obstetrics & Gynecology
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Erin Rothwell

  • Erin Rothwell, MD, PRINCIPAL_INVESTIGATOR, University of Utah

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 Date2024-05-15
Study Completion Date2028-01-30

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2028-01-30

Terms related to this study

Keywords Provided by Researchers

  • newborn screening
  • informed consent
  • biobanking

Additional Relevant MeSH Terms

  • Implementation Science
  • Informed Consent
  • Neonatal Screening