Effect of a Childcare Resource on Cervical Cancer Prevention

NCT06086054 | Terminated

• 1 other identifier: STU-2021-0309
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cervical Dysplasia

Keywords

Childcare; Social determinant of health; Patient navigation

Outcome Measures

Primary Outcomes (1)

• Show-rate for initial visit to gynecology dysplasia clinic

  Show-rate assessed via EMR

  Up to 2 years

Secondary Outcomes (3)

• Rate of completion of indicated diagnostic and therapeutic procedures

  Up to 2 years

• Show-rate for follow-up visits in gynecology

  Up to 2 years

• Rate of utilization of childcare facility during scheduled gynecology visits

  Up to 2 years

Other Outcomes (1)

• Questionnaire of patient-centered outcomes about experience in health system and in gynecology clinic

  Up to 2 years

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Standard Care

NO INTERVENTION

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.

Interventions

Navigation and EMR referral to childcare facility BEHAVIORAL

See arm description

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant women
• Patients \<18 years of age

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 36261213 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Anisha Ganguly, MD, MPH

  Parkland Health & Hospital System - - Dallas, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 17, 2023
• Study Start: October 31, 2023
• Primary Completion: January 7, 2025
• Study Completion: June 30, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)