← Back to Search

Social Needs Support for Cervical Cancer Screening Follow-Up (BASICS Trial)

N/A

Waitlist Available

Led By Lindsay M Kuroki, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of study enrollment (estimated to be 18 months)

Awards & highlights

BASICS Trial Summary

This trial will test whether a social needs navigator program can help low-income, uninsured, or Medicaid patients who are referred for colposcopy and are screened for unmet social needs and distress.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-medical interventions focused on social support rather than drugs or medical procedures, traditional side effects are not expected. However, participants may experience varying levels of emotional discomfort when discussing personal needs.

BASICS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of study enrollment (estimated to be 18 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of study enrollment (estimated to be 18 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of study enrollment (estimated to be 18 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit

Secondary outcome measures

Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List

Intent to use intervention over time

Likelihood that intervention will become built into usual care

+4 more

BASICS Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Social needs navigator programExperimental Treatment1 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 providerActive Control1 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 careActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH

321 Previous Clinical Trials

401,668 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,934 Previous Clinical Trials

2,299,654 Total Patients Enrolled

National Center for Advancing Translational Science (NCATS)NIH

99 Previous Clinical Trials

36,228 Total Patients Enrolled

Media Library

Enhanced usual care Clinical Trial Eligibility Overview. Trial Name: NCT05458960 — N/A

Cervical Cancer Research Study Groups: Arm 3: Clinic provider, Arm 1: Social needs navigator program, Arm 2: Enhanced usual care

Cervical Cancer Clinical Trial 2023: Enhanced usual care Highlights & Side Effects. Trial Name: NCT05458960 — N/A

Enhanced usual care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05458960 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enroll in this trial presently?

"Evidently, this clinical trial is no longer seeking participants. Initially posted on October 31st 2022 and updated most recently on July 13th 2022; individuals can not join the study at this time. Alternately, 397 other medical trials are currently accepting applicants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate

2024. "Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05458960.