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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Behavioral: Social needs navigator program
* Behavioral: Enhanced usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Social needs navigator program<br>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<br>* 4 months of assistance tailored to the needs of the participant<br>|
| Active Comparator: Arm 2: Enhanced usual care<br>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<br>* Referral to United Way 2-1-1<br>|
| No Intervention: Arm 3: Clinic provider<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colposcopy, Cervical cancer prevention, Adherence to follow-up, Unmet social needs, Distress