Social Needs Support for Cervical Cancer Screening Follow-Up

(BASICS Trial)

Recruiting at 1 trial location

Overseen By Lindsay M Kuroki, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: No cervix, Cancer history, others

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

Compensation: Varies

Number of Visits: Unknown

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if extra social support helps women follow up on abnormal cervical cancer screening results. Participants will either receive assistance from a community health worker to address social needs, such as transportation and accessing services, through the Social Needs Navigator program, or receive information about a 24-hour assistance hotline. The trial targets women over 21 who have had an abnormal cervical cancer screen and missed a follow-up appointment. The goal is to identify which approach better supports women in obtaining necessary follow-up care. As an unphased study, this trial offers a unique opportunity to contribute to research that may enhance support systems for women needing follow-up care.

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 these methods are safe for addressing social needs in cervical cancer screening follow-up?

Research has shown that specific safety data for the social needs navigator program is not available. However, similar programs that assist patients with their social needs are generally safe. These programs aim to help patients maintain their medical appointments. As this study does not involve medication or medical procedures, the risk of harm remains low.

Participants in the program will receive assistance from a community health worker to find resources and overcome challenges. This type of support has been used in other health programs without major safety issues. Overall, the goal is to improve access to care without introducing medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support cervical cancer screening follow-up, particularly addressing patients' social needs, which are often overlooked in traditional care. The Social Needs Navigator Program sets itself apart by pairing participants with community health workers who provide personalized support, including home visits and tailored assistance to access community resources. This approach aims to holistically address barriers to care, such as transportation and service access, which can significantly improve patient outcomes. Unlike the standard care options, which typically involve basic referrals to assistance hotlines, this program offers hands-on, continuous support to help patients navigate their social challenges effectively.

What evidence suggests that this trial's treatments could be effective for cervical cancer screening follow-up?

Research has shown that patient navigation programs, such as the Social Needs Navigator Program studied in this trial, can significantly improve cancer care. These programs have increased the number of people returning for follow-up cervical cancer screenings. For example, one study found that these programs boosted screening and follow-up visits in communities facing healthcare challenges. They guide patients through the healthcare system, ensuring access to necessary resources and support. By addressing unmet social needs, these programs reduce the number of patients who fail to return for follow-up after abnormal screening results. This support is crucial for timely medical care and potentially better health outcomes. ^{4 6 7 8 9}

Who Is on the Research Team?

Lindsay M Kuroki, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals aged 21 or older who have had an abnormal cervical cancer screening and need a follow-up colposcopy. It's specifically for low-income patients, uninsured, or those on Medicaid who speak English and missed their initial appointment at Washington University School of Medicine.

Inclusion Criteria

Missed appointment at WUSM colposcopy clinic and need to reschedule

Abnormal cervical cancer screen

Able to provide verbal consent

Exclusion Criteria

I do not have a cervix.

I am unable to give consent by myself.

I have been diagnosed with or have a history of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Intervention

Participants are randomized to either the social needs navigator program or enhanced usual care

4 months

Visits as needed based on participant's needs

Follow-up

Participants are monitored for changes in unmet basic needs and distress scores

4 months

Completion and Evaluation

Evaluation of patient and provider satisfaction with the intervention and resources needed for sustainability

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care
• Social needs navigator program

Trial Overview The study compares two approaches: one group will receive support from a social needs navigator program to address unmet social needs and distress, while the other group gets enhanced usual care. Participants are randomly assigned to either group in equal numbers.

How Is the Trial Designed?

Group I: Arm 1: Social needs navigator program Experimental Treatment 1 Intervention

Participants will be paired with a community health worker who will provide tailored support to address unmet social needs. The number and frequency of calls will be limited only by participants' needs, interest, and willingness to interact. The type of contact could include phone calls, or home/community visits. The community health worker will: (1) identify and assess patients' unmet social needs; (2) jointly generate solutions; (3) help prioritize among multiple needs; (4) identify community resources that could help resolve the problem(s); (5) determine eligibility for services; (6) help patients access available resources by scheduling appointments and providing appointment reminders; (7) prepare patients to interact with service agencies and/or act as an advocate; (8) provide support such as arranging transportation; (9) oversee follow-up problem-solving actions; and (10) review progress made towards resolving unmet social needs and adapt solutions.

Group II: Arm 3: Clinic provider Active Control 1 Intervention

4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.

Group III: Arm 2: Enhanced usual care Active Control 1 Intervention

Participants will receive verbal referral to a federally funded, free, 24-hr assistance hotline, United Way 2-1-1, which connects callers with community services to help address unmet social needs.

Enhanced usual care is already approved in United States for the following indications:

Approved in United States as Podimetrics SmartMat for:

• Prevention of diabetic foot ulcers

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

National Center for Advancing Translational Science (NCATS)

Collaborator

Trials

100

Recruited

32,100+

Published Research Related to This Trial

Transportation challenges significantly hindered women's ability to attend post-treatment follow-up appointments after thermocoagulation for cervical cancer, despite the availability of same-day treatment.

Male partners played a dual role in women's follow-up care: they were seen as barriers for some women, while for others, they provided essential support and encouragement, highlighting the need for increased male involvement in cervical cancer screening initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to follow-up after an abnormal cervical cancer screening result and the role of male partners: a qualitative study. Chapola, J., Lee, F., Bula, A., et al.[2022]

A culturally sensitive telephone counseling intervention for 23 Latina-American cervical cancer survivors showed significant improvements in physical well-being and overall quality of life after 6 sessions.

The study indicates that such behavioral interventions are feasible and beneficial for this population, suggesting the need for further randomized controlled trials to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing physical well-being and overall quality of life among underserved Latina-American cervical cancer survivors: feasibility study. Ashing-Giwa, KT.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0002937825002704

Provider insights to improve colposcopy adherence and ... Despite over 80% of women in the United States having access to cervical cancer screening, approximately 37% to 77% are lost to follow-up after an abnormal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7573022/

Effectiveness of Patient Navigation to Increase Cancer ... This study evaluates the effectiveness of patient navigation to increase screening for colorectal, breast, and cervical cancer in populations adversely ...

3. womenspreventivehealth.org womenspreventivehealth.org/wp-content/uploads/Patient-Navigation-Evidence-Review-Nov-25-2024.pdf

Patient Navigation Services for Breast and Cervical Cancer ... Outcomes included breast and cervical cancer screening rates within 1 year of the intervention, follow-up rates within 2 years, and any type of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10880967/

Interventions to increase follow-up of abnormal cervical ... The purpose of the study was to review single and multicomponent interventions designed to improve follow-up of women with abnormal cervical cancer screening ...

5. researchgate.net researchgate.net/publication/391129903_Provider_insights_to_improve_colposcopy_adherence_and_feasibility_of_a_social_needs_navigator_program

Provider insights to improve colposcopy adherence and ... Provider insights to improve colposcopy adherence and feasibility of a social needs navigator program. April 2025; American Journal of ...

6. reporter.nih.gov reporter.nih.gov/project-details/10657708

RePORT RePORTER - National Institutes of Health (NIH) | These pilot data suggest that a social needs navigator program improves colposcopy adherence, but the lack of randomization limits the strength of our ...

7. reporter.nih.gov reporter.nih.gov/search/uwEWiaNqPUWZS1z4k_nr5Q/project-details/10657708

RePORT RePORTER - National Institutes of Health (NIH) | These pilot data suggest that a social needs navigator program improves colposcopy adherence, but the lack of randomization limits the strength of our ...

8. withpower.com withpower.com/trial/phase-uterine-cervical-neoplasms-9-2022-b6518

Social Needs Support for Cervical Cancer Screening Follow-Up Is the Social Needs Support for Cervical Cancer Screening Follow-Up generally safe for humans? The research does not provide specific safety data for the Social ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2352578922002284

comparing a self-administered screening tool to a cancer ... This social needs screening tool successfully identifies unmet social needs for most of our gynecologic oncology patients.