Social Needs Support for Cervical Cancer Screening Follow-Up

(BASICS Trial)

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

Trial Summary

What is the purpose of this trial?

The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).

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 Enhanced usual care, Remote Foot Temperature Monitoring, Podimetrics SmartMat, Social needs navigator program for cervical cancer screening follow-up?

The study on the use of patient-reported outcome measures (PROMs) suggests that identifying unmet needs can improve supportive care for women with cervical cancer, which may indirectly support the effectiveness of a social needs navigator program. Additionally, the study on cervical cancer screening uptake highlights that addressing health-related social needs can improve screening rates, suggesting that social support interventions could be beneficial. ^{1 2 3 4 5}

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 Needs Support program, but related treatments like thermal ablation for cervical precancer have been reported to cause pain, discharge, and bleeding during recovery. Despite these side effects, most participants found the treatment acceptable and would recommend it to others. ^{5 6 7 8 9}

How is the Social Needs Support for Cervical Cancer Screening Follow-Up treatment different from other treatments?

This treatment is unique because it combines enhanced usual care with a social needs navigator program, which includes tools like Remote Foot Temperature Monitoring and the Podimetrics SmartMat, to address social factors that may affect follow-up care. Unlike traditional treatments that focus solely on medical interventions, this approach aims to support patients by addressing social needs that can impact their ability to complete cervical cancer screening and follow-up. ^{1 2 3 4 5}

Research Team

Lindsay M Kuroki, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

My cervical screening test showed abnormal results.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Advanced cervical cancer treatment in Harris County: pilot evaluation of factors that prevent optimal therapy. [2021]

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

Feasibility and Acceptability of the Use of Patient-Reported Outcome Measures in the Delivery of Nurse-Led, Supportive Care to Women With Cervical Cancer. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Uptake of Cervical Cancer Screening Among Female Patients Using a Mobile Medical Clinic. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Spatial evaluation of prevalence, pattern and predictors of cervical cancer screening in India. [2020]

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

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

6. England 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. [2022]

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

Experiences with thermal ablation for cervical precancer treatment after self-collection HPV-based screening in the ASPIRE Mayuge randomized trial. [2023]

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

Abnormal cervical screen follow-up among low-income Latinas: Project SAFe. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Implementation and scale-up of a single-visit, screen-and-treat approach with thermal ablation for sustainable cervical cancer prevention services: a protocol for a stepped-wedge cluster randomized trial in Kenya. [2023]