NCT05458960

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
2.7 years until next milestone

Study Start

First participant enrolled

March 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2025

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

July 8, 2022

Last Update Submit

May 6, 2026

Conditions

Cervical Cancer

Keywords

ColposcopyCervical cancer preventionAdherence to follow-upUnmet social needsDistress

Outcome Measures

Primary Outcomes (1)

  • Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit

    6 weeks after enrollment

Secondary Outcomes (7)

  • Total number of unmet basic needs

    4 months after enrollment

  • Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List

    Enrollment and 4 months after enrollment

  • Intent to use intervention over time

    Completion of study enrollment (estimated to be 18 months)

  • Patients' satisfaction with intervention

    Completion of study enrollment (estimated to be 18 months)

  • Providers' satisfaction with intervention

    Completion of study enrollment (estimated to be 18 months)

  • +2 more secondary outcomes

Study Arms (3)

Arm 1: Social needs navigator program

EXPERIMENTAL

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

Arm 2: Enhanced usual care

ACTIVE COMPARATOR

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

Arm 3: Clinic provider

NO INTERVENTION

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

Interventions

Enhanced usual careBEHAVIORAL

Referral to United Way 2-1-1

Arm 2: Enhanced usual care
Social needs navigator programBEHAVIORAL

4 months of assistance tailored to the needs of the participant

Arm 1: Social needs navigator program

Eligibility Criteria

Age21 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individual without a cervix
  • Known diagnosis or history of cancer
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Lindsay M Kuroki, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 14, 2022

Study Start

March 28, 2025

Primary Completion

August 28, 2025

Study Completion

November 17, 2025

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)