Effect of a Childcare Resource on Cervical Cancer Prevention

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

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).

Study Overview

• Status: Terminated
• Conditions: Cervical Dysplasia
• Intervention / Treatment: Behavioral: Navigation and EMR referral to childcare facility

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women
• Patients <18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; The intervention is comprised of two components to link randomized patients to our health system childcare facility: 1) navigation by the research assistant to the childcare facility and 2) placement of the facility EMR referral. Navigation will occur an eligible patient is randomized to the intervention group. Navigation will consist of the research assistant educating the patient about the childcare facility and providing information about how to access the childcare facility during the telephone contact and via mailed written materials.	Behavioral: Navigation and EMR referral to childcare facility; See arm description
No Intervention: Standard Care; Patients randomized to the control group will undergo current standard of care with regards to childcare, which currently consists of passive sources of information about our childcare facility (Parkland website, signage in the hospital, or via word of mouth). Currently, there is no formalized mechanism for patients referred to gynecology from primary care to receive information about childcare aside from the above passive sources of information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Show-rate for initial visit to gynecology dysplasia clinic	Show-rate assessed via EMR	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of completion of indicated diagnostic and therapeutic procedures	May include colposcopy, biopsies, and cervical excisional procedures, including hysterectomy, in the clinic and operating room (OR). Will vary based on clinical indication and assessment during initial appointment.	Up to 2 years
Show-rate for follow-up visits in gynecology	Show-rate assessed via EMR	Up to 2 years
Rate of utilization of childcare facility during scheduled gynecology visits	Rate of utilization assessed by health system's dashboard for childcare facility	Up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire of patient-centered outcomes about experience in health system and in gynecology clinic	Designed questions in a follow-up survey administered via telephone after initial appointment	Up to 2 years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Anisha Ganguly, MD, MPH, Parkland Health & Hospital System - - Dallas, TX

Publications and helpful links

General Publications

• Alvarez KS, Bhavan K, Mathew S, Johnson C, McCarthy A, Garcia B, Callies M, Stovall K, Harms M, Kho KA. Addressing childcare as a barrier to healthcare access through community partnerships in a large public health system. BMJ Open Qual. 2022 Oct;11(4):e001964. doi: 10.1136/bmjoq-2022-001964.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Actual): January 7, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: October 10, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Patient navigation; Childcare; Social determinant of health
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Precancerous Conditions; Uterine Cervical Diseases; Uterine Cervical Dysplasia
• Other Study ID Numbers: STU-2021-0309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not permitted under our system's Office of Research Administration policies with regards to this type of collected patient data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No