Effect of a Childcare Resource on Cervical Cancer Prevention

Last updated: November 18, 2024
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Dysplasia

Treatment

Navigation and EMR referral to childcare facility

Clinical Study ID

NCT06086054
STU-2021-03-09
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All women with abnormal cervical cancer screening referred to Parkland gynecologydysplasia clinic as a new patient

Exclusion

Exclusion Criteria:

  • Pregnant women

  • Patients <18 years of age

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Navigation and EMR referral to childcare facility
Phase:
Study Start date:
October 31, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Parkland Health

    Dallas, Texas 75235
    United States

    Active - Recruiting

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