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

Not Applicable

Recruiting

• Conditions: Cervical Cancer

• Registration Number: NCT05458960
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-14
• Status Verified: 2025-03
• Study Start: 2025-03-28
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit	6 weeks after enrollment

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction with intervention	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?
Total number of unmet basic needs	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.
Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List	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".
Providers' satisfaction with intervention	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.
Resources needed to sustain intervention	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.
Likelihood that intervention will become built into usual care	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.
Intent to use intervention over time	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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States