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Childcare Support for Cervical Cancer Prevention
N/A
Recruiting
Led By Anisha Ganguly, MD, MPH
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* All women with abnormal cervical cancer screening referred to Parkland gynecology dysplasia clinic as a new patient
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the effect of health system-integrated childcare on women's completion of cervical cancer screening & diagnostic work-up. Findings will inform future research to address childcare as a social determinant of health.
Who is the study for?
This trial is for women with abnormal cervical cancer screening results who are new patients at the Parkland gynecology dysplasia clinic. It aims to help those facing childcare issues which may affect their ability to attend medical appointments.
What is being tested?
The study tests if helping these women get childcare (through navigation and an electronic medical record referral) before their first clinic visit can improve their attendance compared to standard care without this support.
What are the potential side effects?
Since the intervention involves providing resources for childcare rather than a medical treatment, there are no direct side effects related to medications or procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Show-rate for initial visit to gynecology dysplasia clinic
Secondary study objectives
Rate of completion of indicated diagnostic and therapeutic procedures
Rate of utilization of childcare facility during scheduled gynecology visits
Show-rate for follow-up visits in gynecology
Other study objectives
Questionnaire of patient-centered outcomes about experience in health system and in gynecology clinic
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: InterventionActive Control1 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.
Group II: Standard CareActive Control1 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.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,483 Total Patients Enrolled
1 Trials studying Cervical Dysplasia
32,771 Patients Enrolled for Cervical Dysplasia
Anisha Ganguly, MD, MPHPrincipal InvestigatorParkland Health & Hospital System - - Dallas, TX