RECRUITING

Building TrUst and UNiting Teams Through DouLa PartnErship - BUNDLE

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 BUNDLE study is a prospective mixed-methods study focused on the early integration of community doula into prenatal care. The study will have three phases: Phase 1 is the qualitative phase of conducting focus groups with Black/African American (AA) birthing people and with medical and community healthcare providers to elicit feedback on how best to integrate community-based doulas and obstetricians into one united model of prenatal care to promote trust and improved maternal health outcomes. Phase 2 tests the effectiveness of the newly developed model on healthcare engagement, trust, and adverse maternal outcomes using randomized control trial of 412 Black/AA pregnant participants. Phase 3 is dissemination of BUNDLE findings in scholarly and community-based forums, including with healthcare leaders and policy makers in Wisconsin, advocating for doula coverage and health system sustainability of the integrated model.

Official Title

Building TrUst and UNiting Teams Through DouLa PartnErship - BUNDLE

Quick Facts

Study Start:2024-11-25
Study Completion:2030-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05993689

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 to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Self-reported Black or African American
  2. * Pregnant with singleton gestation
  3. * Has an established OBGY at Froedtert \& the Medical College of Wisconsin (F\&MCW) Health System
  1. * Planning to deliver outside of F\&MCW Health System
  2. * Receiving support beyond routing prenatal care, such as group prenatal care or has their own doula
  3. * Inability or unwillingness to provide informed consent

Contacts and Locations

Study Contact

Anna Palatnik, MD
CONTACT
(414) 805-6624
apalatnik@mcw.edu
Joni S Williams, MD, MPH
CONTACT
(414) 955-8827
jswilliams@mcw.edu

Study Locations (Sites)

Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

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 Date2024-11-25
Study Completion Date2030-06-30

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2030-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy Related