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Spots Global Cancer Trial Database for Effect of a Childcare Resource on Cervical Cancer Prevention

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Trial Identification

Brief Title: Effect of a Childcare Resource on Cervical Cancer Prevention

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

Study ID: NCT06086054

Study Description

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).

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Parkland Health, Dallas, Texas, United States

Contact Details

Name: Anisha Ganguly, MD, MPH

Affiliation: Parkland Health & Hospital System - - Dallas, TX

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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