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

April 15, 2024 updated by: Washington University School of Medicine

Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate: The BASICS 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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Lindsay M Kuroki, M.D.
        • Sub-Investigator:
          • Mary Mullen, M.D.
        • Sub-Investigator:
          • Andrea Hagemann, M.D.
        • Sub-Investigator:
          • Premal H Thaker, M.D., M.S.
        • Sub-Investigator:
          • Esther Lu, Ph.D.
        • Sub-Investigator:
          • L. Stewart Massad, M.D.
        • Sub-Investigator:
          • David G Mutch, M.D.
        • Sub-Investigator:
          • Matthew A Powell, M.D.
        • Sub-Investigator:
          • Carolyn K McCourt, M.D.
        • Sub-Investigator:
          • Dineo Khabele, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Abnormal cervical cancer screen
  • Missed appointment at WUSM colposcopy clinic and need to reschedule
  • Age 21 years or older
  • English-speaking
  • Able to provide verbal consent
  • Diagnosis of an abnormal cervical screen confirmed by cytology or pathology

Exclusion Criteria:

  • Individual without a cervix
  • Known diagnosis or history of cancer
  • Unable to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Social needs navigator program
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.
Behavioral: Social needs navigator program
4 months of assistance tailored to the needs of the participant
Active Comparator: Arm 2: Enhanced usual care
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.
Behavioral: Enhanced usual care
Referral to United Way 2-1-1
No Intervention: Arm 3: Clinic provider
4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit
Time Frame: 6 weeks after enrollment
6 weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of unmet basic needs
Time Frame: 4 months after enrollment
-Unmet basic needs include food security, housing, personal safety, neighborhood safety, sufficient money for necessities, childcare (if applicable), and transportation. A questionnaire will be given to participants to identify the number of unmet basic needs the participant has.
4 months after enrollment
Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List
Time Frame: Enrollment and 4 months after enrollment
Participants will be asked to rate the amount of distress (scale of 0 to 10, 10=extreme distress) that they have experienced in the past week and the amount of distress (scale of 0 to 10) that they attribute to their abnormal cervical cancer screen. The NCCN distress problem list is a 40-item list categorized into five themes-practical, family, emotional, spiritual, and physical problems¬-and leaves room for patients to describe "other".
Enrollment and 4 months after enrollment
Intent to use intervention over time
Time Frame: Completion of study enrollment (estimated to be 18 months)
-Providers are asked after completion of enrollment to indicate on a scale of 1=not committed to 10=fully committed of how committed they are to use the intervention in their clinic.
Completion of study enrollment (estimated to be 18 months)
Patients' satisfaction with intervention
Time Frame: Completion of study enrollment (estimated to be 18 months)
-The interview guide has two questions that relate to patient satisfaction related to the intervention. 1) Was the [community health worker or 2-1-1 operator] helpful to you? 2) Would you recommend [the community healthworker/2-1-1] to a family member or friend?
Completion of study enrollment (estimated to be 18 months)
Providers' satisfaction with intervention
Time Frame: Completion of study enrollment (estimated to be 18 months)
-Providers are asked after completion of enrollment to indicate their satisfaction with the intervention. They are given 12 statements about the satisfaction of the intervention and are asked to circle responses of 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, or 5=completely agree. The higher the score the more satisfied the provider is with the intervention.
Completion of study enrollment (estimated to be 18 months)
Resources needed to sustain intervention
Time Frame: Completion of study enrollment (estimated to be 18 months)
-Validated questionnaire that will be administered to providers, staff, and community health workers: Self-administered 15-minute online survey that will be completed at the end of the study enrollment period. The survey will ask about specific implementation outcomes using the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure.
Completion of study enrollment (estimated to be 18 months)
Likelihood that intervention will become built into usual care
Time Frame: Completion of study enrollment (estimated to be 18 months)
-Providers are asked after completion of enrollment to indicate the likelihood that the intervention can be built into usual care in their clinic. The responses are either likely, very likely, neutral, unlikely, very unlikely, or unsure.
Completion of study enrollment (estimated to be 18 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Center for Advancing Translational Sciences (NCATS)

Investigators

  • Principal Investigator: Lindsay M Kuroki, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202205183
  • 1R03TR004017-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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