TERMINATED

Effect of a Childcare Resource on Cervical Cancer Prevention

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

Aim 1: Determine the prevalence of unmet childcare needs among women with abnormal cervical cancer screening and establish the relevance of childcare as a social determinant of health in the context of cervical dysplasia. Aim 2: Conduct a pilot pragmatic patient-randomized control trial (RCT) to evaluate the effectiveness of an intervention linking eligible patients to our childcare facility compared to standard of care on retention in care, defined as show-rate for the initial visit in the gynecology dysplasia clinic. The intervention will consist of 1) patient navigation to our childcare facility prior to the initial visit in the gynecology dysplasia clinic and 2) placement of an electronic medical record (EMR) referral to our childcare facility. Hypothesis: The study team hypothesizes that women receiving the intervention will have increased retention in care compared to women randomized to standard of care among women with abnormal cervical cancer screening referred to gynecology for diagnostic work-up. These two aims will demonstrate the significance of childcare as a social determinant of health in the cervical cancer screening and diagnostic continuum by assessing the burden of unmet childcare needs among women with cervical dysplasia and measuring the effect of health system-integrated childcare as an intervention for unmet childcare needs on retention in care and subsequent completion of diagnostic work-up among women with cervical dysplasia. This study will rigorously provide the first evidence illustrating the effect of health systems' investment in addressing unmet childcare needs on preventive care like cervical cancer screening. The findings of this proposed pilot study will be utilized to develop future large-scale studies with extramural funding, building a longitudinal program of research on addressing childcare as a social determinant of health in this and other similar clinical contexts (e.g., breast cancer screening and treatment).

Official Title

Effectiveness of a Childcare Intervention on Retention in the Cervical Cancer Screening and Diagnostic Continuum

Quick Facts

Study Start:2023-10-31
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06086054

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:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All women with abnormal cervical cancer screening referred to Parkland gynecology dysplasia clinic as a new patient
  1. * Pregnant women
  2. * Patients \<18 years of age

Contacts and Locations

Principal Investigator

Anisha Ganguly, MD, MPH
PRINCIPAL_INVESTIGATOR
Parkland Health & Hospital System - - Dallas, TX

Study Locations (Sites)

Parkland Health
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Anisha Ganguly, MD, MPH, PRINCIPAL_INVESTIGATOR, Parkland Health & Hospital System - - Dallas, TX

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 Date2023-10-31
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-10-31
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Childcare
  • Social determinant of health
  • Patient navigation

Additional Relevant MeSH Terms

  • Cervical Dysplasia