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

Phase 1

Completed

• Conditions: Abnormal Pap Smear; Colposcopy
• Interventions: Other: Basic needs survey; Other: Follow-up survey; Behavioral: Life Navigator; Other: Follow-up survey (phase II participants only)

• 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase I:	Follow-up survey	* In Phase 1 of the study (first five months), the investigators will enroll new patients when they call them to remind them of their first colposcopy appointment. If patients consent, the investigators also will assess their basic needs during the call. Those who screen positive for at least one unmet basic need, will be referred to the 2-1-1 helpline at their clinic visit (or this information will be sent to them if they miss their clinic visit). * All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit. * For patients in phase 1, the follow-up survey will only assess acceptability of the basic needs survey (five questions)
Phase 2:	Life Navigator	-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey. The life navigator will connect patients with community resources in each area to help with their unmet basic needs. * All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit. * Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator
Phase I:	Basic needs survey	* In Phase 1 of the study (first five months), the investigators will enroll new patients when they call them to remind them of their first colposcopy appointment. If patients consent, the investigators also will assess their basic needs during the call. Those who screen positive for at least one unmet basic need, will be referred to the 2-1-1 helpline at their clinic visit (or this information will be sent to them if they miss their clinic visit). * All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit. * For patients in phase 1, the follow-up survey will only assess acceptability of the basic needs survey (five questions)
Phase 2:	Basic needs survey	-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey. The life navigator will connect patients with community resources in each area to help with their unmet basic needs. * All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit. * Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator
Phase 2:	Follow-up survey	-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey. The life navigator will connect patients with community resources in each area to help with their unmet basic needs. * All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit. * Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator
Phase 2:	Follow-up survey (phase II participants only)	-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey. The life navigator will connect patients with community resources in each area to help with their unmet basic needs. * All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit. * Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator

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
Type 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
Number of unmet basic needs	-2 weeks prior to initial colposcopy visits	-Data obtained from Basic Needs Survey
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)

Trial Locations

Locations (2)

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

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