Childcare Support for Cervical Cancer Prevention

Overseen By Anisha Ganguly, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how access to childcare affects women dealing with abnormal cervical cancer screenings. It aims to determine if providing childcare support helps women attend their medical appointments, compared to those relying solely on usual information sources for childcare. Women informed of abnormal cervical cancer screenings and who are new patients at the gynecology dysplasia clinic may qualify. The trial seeks to highlight childcare as a key factor in managing health screenings and treatments. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance healthcare access for women facing similar challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this childcare intervention is safe for improving retention in cervical cancer care?

Research has shown that reliable childcare helps women keep medical appointments, especially for crucial health checks like cancer screenings. Studies have found that women with childcare support are more likely to attend cervical cancer screenings. When childcare is available, women can focus on their health without worrying about who will watch their children.

In this trial, the main "treatment" involves providing access to a childcare facility. No medication or medical procedure is involved, so typical safety concerns like side effects do not apply. The goal is to ensure women have the childcare support they need to attend health appointments. This type of support is considered safe because it offers a helpful resource, not a physical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a new approach to support cervical cancer prevention by addressing childcare barriers. Unlike standard care, which relies on passive information like hospital signage or websites, the trial provides a hands-on approach. It includes navigation assistance by a research assistant and an EMR referral to connect patients directly to childcare services. This proactive strategy aims to make it easier for patients to attend crucial medical appointments, which could enhance prevention efforts and improve health outcomes.

What evidence suggests that this intervention is effective for improving retention in care for women with cervical dysplasia?

Research has shown that childcare availability can greatly increase women's participation in cancer screenings, such as those for cervical cancer. Studies have found that when childcare is accessible, women are more likely to attend their screening appointments, which are crucial for early cancer detection and treatment. This trial will compare two approaches: an intervention group receiving active navigation and referral to a childcare facility, and a control group receiving standard care with passive information sources. Specifically, one study highlighted that offering childcare support helped women regularly undergo cervical cancer screenings. Additionally, meeting childcare needs is considered a cost-effective way to boost cancer screening rates. These findings suggest that providing childcare resources can effectively help more women complete their necessary health screenings. ^{1 3 5 6 7}

Who Is on the Research Team?

Anisha Ganguly, MD, MPH

Principal Investigator

Parkland Health & Hospital System - - Dallas, TX

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman referred to the Parkland dysplasia clinic for an abnormal cervical cancer screening result.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive navigation to the childcare facility and an EMR referral to improve retention in care

Up to 2 years

Initial visit to gynecology dysplasia clinic

Follow-up

Participants are monitored for retention in care and completion of diagnostic procedures

Up to 2 years

Follow-up visits in gynecology

What Are the Treatments Tested in This Trial?

Interventions

• Childcare Resource

Trial Overview

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.

How Is the Trial Designed?

Group I: Intervention Active Control 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

A study involving 25 children aged 1 to 6 years with newly diagnosed cancer and their parents highlighted that nurses' caring practices are crucial in supporting families through the transition to a 'new normal' during treatment and follow-up.

Key aspects of effective nursing care included building trust, providing clear information, and showing genuine interest in the family's life outside the hospital, suggesting the need for standardized nursing care guidelines to enhance these practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Young Children With Cancer and Their Parents With Nurses' Caring Practices During the Cancer Trajectory. Enskär, K., Darcy, L., Björk, M., et al.[2020]

The quality of child care in the U.S. is generally poor, which negatively affects family stability, workforce productivity, and child health and development.

Healthcare professionals, including pediatricians and nurses, can significantly improve child care quality by supporting parents, educating child care providers, offering preventive services, advocating for better services, and making referrals for care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making a difference for children: the medical community's role in improving child care. Reisman, B.[2019]

A study involving 114 parents and 121 nurses identified key aspects of care for parents of children with cancer, highlighting the importance of social competence and information for parents, while nurses emphasized emotional support and information.

Both parents and nurses recognized the need for accessible care and emotional support, with many parents specifically requesting assistance in emotional and instrumental support to help maintain a normal family life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Important aspects of care and assistance for parents of children, 0-18 years of age, on or off treatment for cancer. Parent and nurse perceptions. von Essen, L., Enskär, K., Skolin, I.[2003]

A study involving interviews with 25 children, 31 parents, and 32 nurses identified key caring aspects for children with cancer, highlighting the importance of social competence, amusement, and meeting basic needs as crucial for the children's sense of care.

While two-thirds of the children did not express a need for help outside the hospital, parents and nurses recognized that emotional support was necessary for one-third of the children, indicating a gap in communication about support needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Important aspects of care and assistance for children with cancer. Enskär, K., von Essen, L.[2017]

Sure Start Children's Centres in England have expanded access to health services for children under five, providing integrated support that includes child health, maternity services, and parenting resources to over 2.4 million families.

These centres play a crucial role in promoting public health priorities, such as breastfeeding and healthy eating, by offering a range of health promotion activities and programs tailored to local community needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sure Start Children's Centres: time to make them better known. Thompson, C.[2016]

A study involving 57 parents and 59 nurses identified key aspects of care for children aged 0-7 with cancer, highlighting the importance of social competence and amusement from parents' perspectives, while nurses emphasized continuity and information.

The findings suggest that effective cancer care for children requires a holistic approach, involving not just medical treatment but also emotional support and family participation to address both biological and psychosocial needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Important aspects of care and assistance for children 0-7 years of age being treated for cancer. Parent and nurse perceptions. von Essen, L., Enskär, K., Haglund, K., et al.[2013]

Affordable nonprofit childcare leads to positive developmental outcomes for children, benefiting not only the children but also their families and society as a whole.

Paediatricians can play a crucial role in advocating for increased access to affordable nonprofit childcare, using this commentary as a resource to support their efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Universal access to quality childcare is good policy and a positive determinant of health. Let's invest. Armstrong, S.[2021]

The Promoting Healthy Development Survey (PHDS) was developed and validated with 1,478 families to assess how well health care providers deliver family-centered anticipatory guidance and child assessments for children aged 0-48 months, showing strong reliability and validity in its measures.

Results indicated significant variations in quality of care across health plans, with higher scores for anticipatory guidance and lower for psychosocial assessments, highlighting areas for improvement in preventive care for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing health system provision of well-child care: The Promoting Healthy Development Survey. Bethell, C., Peck, C., Schor, E.[2019]

The authors emphasize the importance of comprehensive child care that goes beyond treating illnesses to include prevention and early detection of developmental problems, especially in children who frequently get sick.

They developed flow sheets for screening visits from two weeks to two years old, which help track various aspects of child health, including growth and development, and facilitate participation from office staff in the assessment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Well baby visits: screening and health promotion. Rourke, JT., Rourke, LL.[2021]

The PediCARE intervention, designed to support pediatric oncology families facing material hardships, was highly accepted by all nine participating families, with no dropouts over the three-month study period.

Families reported high satisfaction with the intervention, particularly the grocery delivery service, and provided valuable feedback that was used to improve the program in real-time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PediCARE: Development of a poverty-targeted intervention for pediatric cancer. Umaretiya, PJ., Revette, A., Seo, A., et al.[2022]

Citations

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Child caregiving and cancer screening: a nationally ...

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Childcare as a social determinant of access to healthcare

Additionally, one study found that having social support for childcare permitted regular cervical cancer screening (54) and another identified free childcare ...

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stacks.cdc.gov/view/cdc/102176/cdc_102176_DS1.pdf

Cost-effectiveness of Leveraging Social Determinants of ...

Included studies intervened on social determinants of health to improve breast, cervical, and colorectal cancer screening in the United. States and reported ...

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jamanetwork.com/journals/jamanetworkopen/fullarticle/2832470

Childcare Barriers and Appointment Nonadherence in a ...

In this cross-sectional study of women in a safety-net health system, self-reported childcare barriers were associated with increased appointment nonadherence.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11986774/

Childcare Barriers and Appointment Nonadherence ...

This cross-sectional study assesses whether self-reported childcare barriers are associated with appointment nonadherence among women at a safety-net health ...