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

Cervical Cancer Clinical Trial

— BASICS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05458960
• Other study ID #: 202205183
• Secondary ID: 1R03TR004017-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 31, 2024
• Est. completion date: April 30, 2026

Study information

• Verified date: June 2024
• Source: Washington University School of Medicine
• Contact: Lindsay M Kuroki, M.D.
• Phone: 314-362-2368
• Email: kurokil[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: April 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Social needs navigator program
4 months of assistance tailored to the needs of the participant
• Enhanced usual care
Referral to United Way 2-1-1

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit		6 weeks after enrollment
Secondary	Total number of unmet basic needs	-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
Secondary	Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List	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
Secondary	Intent to use intervention over time	-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)
Secondary	Patients' satisfaction with intervention	-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)
Secondary	Providers' satisfaction with intervention	-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)
Secondary	Resources needed to sustain intervention	-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)
Secondary	Likelihood that intervention will become built into usual care	-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)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine