Social Needs Support for Cervical Cancer Screening Follow-Up
(BASICS Trial)
What You Need to Know Before You Apply
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.
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.12345
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.36789
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.36789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Randomization and Intervention
Participants are randomized to either the social needs navigator program or enhanced usual care
Follow-up
Participants are monitored for changes in unmet basic needs and distress scores
Completion and Evaluation
Evaluation of patient and provider satisfaction with the intervention and resources needed for sustainability
What Are the Treatments Tested in This Trial?
Interventions
- Enhanced usual care
- Social needs navigator program
Enhanced usual care is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
National Center for Advancing Translational Sciences (NCATS)
Collaborator
National Center for Advancing Translational Science (NCATS)
Collaborator