Arm 1: Social needs navigator program for Uterine Cervical Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Uterine Cervical Neoplasms+1 More
Social needs navigator program - Behavioral
Eligibility
18+
Female
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Uterine Cervical Neoplasms
  • Cervical Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Uterine Cervical Neoplasms

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Completion of study enrollment (estimated to be 18 months)

4 months after enrollment
Total number of unmet basic needs
6 weeks after enrollment
Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit
Month 18
Intent to use intervention over time
Likelihood that intervention will become built into usual care
Patients' satisfaction with intervention
Providers' satisfaction with intervention
Resources needed to sustain intervention
Month 4
Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List

Trial Safety

Safety Progress

1 of 3

Other trials for Uterine Cervical Neoplasms

Trial Design

3 Treatment Groups

Arm 3: Clinic provider
1 of 3
Arm 2: Enhanced usual care
1 of 3
Arm 1: Social needs navigator program
1 of 3
Active Control
Experimental Treatment

81 Total Participants · 3 Treatment Groups

Primary Treatment: Arm 1: Social needs navigator program · No Placebo Group · N/A

Arm 1: Social needs navigator program
Behavioral
Experimental Group · 1 Intervention: Social needs navigator program · Intervention Types: Behavioral
Arm 3: Clinic providerNoIntervention Group · 1 Intervention: Arm 3: Clinic provider · Intervention Types:
Arm 2: Enhanced usual care
Behavioral
ActiveComparator Group · 1 Intervention: Enhanced usual care · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: completion of study enrollment (estimated to be 18 months)
Closest Location: Washington University School of Medicine · Saint Louis, MO
Photo of washington university school of medicine  1Photo of washington university school of medicine  2Photo of washington university school of medicine  3
2004First Recorded Clinical Trial
23 TrialsResearching Uterine Cervical Neoplasms
1465 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have not attended colposcopy clinic at WUSM for the past 12 months and need to reschedule.
You must be aged 21 years or older at the time of screening.
You are able to provide verbal consent.
You have a diagnosis of an abnormal cervical screen.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.