Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap

Phase 1

Completed

• Conditions: Abnormal Pap Smear; Colposcopy

• Registration Number: NCT03317470
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap and effectively reduce disparities in cervical cancer risk and disease among rural and low-income urban women.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-29
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-23
• Primary Completion: 2018-12-09
• Study Completion: 2018-12-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• Newly referred patients to colposcopy clinic at SIUM and WUSM
• Aged 18 years or older
• English speaking
• Able to provide verbal consent
• Diagnosis of abnormal pap will be confirmed by pathology report
• Member of all races and ethnic groups

Exclusion Criteria

• Male
• Established colposcopy clinic patients
• Known diagnosis of cancer
• Pregnancy
• Incarcerated
• Unable to consent
• No access to a working contact phone number

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Participant adherence to initial colposcopy visit	At the time of initial colposcopy visit	-Will use weekly clinic schedules to track adherence rates

Secondary Outcome Measures

Name	Time	Method
Number of unmet basic needs	-2 weeks prior to initial colposcopy visits	-Data obtained from Basic Needs Survey
Participant adherence to recommended follow-up after initial colposcopy visit	At the time of initial colposcopy visit	-Data will be collected for each participant to notate whether participant showed up for recommended follow-up visit and will be tabulated for all participants
Participant acceptability of the unmet basic needs survey	At the time of initial colposcopy visit
Participant perception of effectiveness of life navigator to assist with their unmet basic needs	At the time of initial colposcopy visit	* Data collected on the follow-up survey; * 7 questions asking the following; * Was the patient navigator helpful (yes with comments/no); * What could the navigator done better (multiple choice and area to add comments); * Did you use any of the resources the navigator told you about (yes with comments/no); * Would you recommend this type of helper to a family member or friend (yes/no); * Were there parts you didn't like or didn't find helpful (yes with comments/no); * Do you think the patient navigator helped you get to your clinic appointments (yes/no); * If available, would you find it helpful to talk to the patient navigator more (yes/no)
Type of unmet basic needs	-2 weeks prior to initial colposcopy visits	-Data obtained from Basic Needs Survey

Trial Locations

Locations (2)

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States