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Terminated

NCT Number: NCT05458960

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

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).

Why the study stopped: Staffing issues
Terminated

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Key information

Age range

21 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Abnormal cervical cancer screen
  • Missed appointment at BJH colposcopy clinic and need to reschedule
  • Age 21 years or older
  • 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

Treatment and study plan

Social needs navigator program

Behavioral

4 months of assistance tailored to the needs of the participant

Enhanced Usual Care

Behavioral

Referral to United Way 2-1-1

Primary outcomes

  1. Adherence to Colposcopy Visit as Measured as Number of Participants Who Complete Colposcopy Visit Within 6 Weeks After Enrollment

    Time frame: From enrollment through 6 weeks after enrollment

Secondary outcomes

  1. 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.

  2. Change in General Distress Score 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". A higher score indicates the greater the amount of distress.

  3. 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.

  4. 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?

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

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

Acronym: BASICS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2022
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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