RECRUITING

Doula Model of Care

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 goal of this randomized controlled intervention trial is to determine if an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP), will improve both the experience and outcomes for Black birthing people. The main question it aims to answer is whether an integrated partnership between a birth worker/community support organization and the Hospital of the University of Pennsylvania (HUP) will mitigate bias and mistrust thereby improving both the experience and outcomes for Black birthing people, assessed by the primary outcome of depression score. Participants will be randomized to Doula care (receive 2 prenatal visits, continuous intrapartum support, and 2 postpartum visits with a certified doula) or standard of care (receive prenatal care, labor and delivery, and postpartum care as they normally would if not in the study) and followed through 6 weeks postpartum.

Official Title

Doula Model of Care, A Randomized Controlled Trial

Quick Facts

Study Start:2025-04-16
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06915259

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:16 Years to 55 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant patients who self-identify (as seen on Chart) as Black
  2. * Ages 16-55
  3. * Currently pregnant and in second trimester (gestational age between 13-30 weeks)
  4. * Plan to deliver at HUP
  5. * Patients must be able to read and understand English
  6. * Participants must be willing and able to sign the informed consent form
  1. * Unable to provide written consent by being unable to read or sign informed consent.
  2. * PI Discretion

Contacts and Locations

Study Contact

Sindhu K Srinivas, MD, MSCE
CONTACT
215-662-2982
ssrinivas@pennmedicine.upenn.edu
Elizabeth Norton, MPH
CONTACT
elizabeth.norton@pennmedicine.upenn.edu

Principal Investigator

Sindhu K Srinivas, MD, MSCE
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Sindhu K Srinivas, MD, MSCE, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Date2025-04-16
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-04-16
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Doula
  • community models of care

Additional Relevant MeSH Terms

  • Perinatal
  • Morbidity
  • Mental Health