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

The Washington University

Status: Terminated

Conditions: Cervical Cancer

Treatments: Behavioral: Enhanced usual care; Behavioral: Social needs navigator program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05458960

202205183

1R03TR004017-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 3 patients

Sex: Female

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

Arm 1: Social needs navigator program

Experimental group

Description:

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.

Treatment:

Behavioral: Social needs navigator program

Arm 2: Enhanced usual care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced usual care

Arm 3: Clinic provider

No Intervention group

Description:

4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.