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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Childcare Resource for cervical cancer prevention?

The research highlights the importance of family support and practical assistance, such as childcare, in managing the psychosocial aspects of cancer treatment. This suggests that providing childcare resources could help alleviate stress for families, potentially improving overall health outcomes. ^{1 2 3 4 5}

How does the childcare support treatment for cervical cancer prevention differ from other treatments?

This treatment is unique because it focuses on providing childcare support to help prevent cervical cancer, which is different from traditional medical treatments that directly target the disease. By ensuring access to quality childcare, it indirectly supports the health and well-being of families, potentially reducing stress and improving overall health outcomes. ^{6 7 8 9 10}

What is the purpose of this trial?

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).

Research Team

Anisha Ganguly, MD, MPH

Principal Investigator

Parkland Health & Hospital System - - Dallas, TX

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

1. Germany 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. [2013]

2. Scotland 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. [2003]

3. United States pubmed.ncbi.nlm.nih.gov

Important aspects of care and assistance for children with cancer. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

PediCARE: Development of a poverty-targeted intervention for pediatric cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Experiences of Young Children With Cancer and Their Parents With Nurses' Caring Practices During the Cancer Trajectory. [2020]

6. England pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

Assessing health system provision of well-child care: The Promoting Healthy Development Survey. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Well baby visits: screening and health promotion. [2021]

10. England pubmed.ncbi.nlm.nih.gov

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