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

NCT03317470 | Completed Phase 1 DMC

• 1 other identifier: 201708116
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Abnormal Pap Smear; Colposcopy

Outcome Measures

Primary Outcomes (1)

• Participant adherence to initial colposcopy visit

  -Will use weekly clinic schedules to track adherence rates

  At the time of initial colposcopy visit

Secondary Outcomes (5)

• Number of unmet basic needs

  -2 weeks prior to initial colposcopy visits

• Type of unmet basic needs

  -2 weeks prior to initial colposcopy visits

• Participant adherence to recommended follow-up after initial colposcopy visit

  At the time of initial colposcopy visit

• 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

Study Arms (2)

Phase I:

ACTIVE COMPARATOR

* 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)

Other: Basic needs survey; Other: Follow-up survey

Phase 2:

EXPERIMENTAL

-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

Other: Basic needs survey; Behavioral: Life Navigator; Other: Follow-up survey; Other: Follow-up survey (phase II participants only)

Interventions

Basic needs survey OTHER

-11 questions about food security, housing personal safety, neighborhood safety, childcare, and transportation

Phase 2:; Phase I:

Life Navigator BEHAVIORAL

* The life navigator will contact women identified with unmet basic needs within two business days of completing the baseline survey. * The life navigator in our study will: (1) identify and assess women's needs; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help women access available resources by scheduling appointments and provide appointment reminders; (8) prepare women to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.

Phase 2:

Follow-up survey OTHER

-5 questions about the acceptability of the basic needs survey

Phase 2:; Phase I:

Follow-up survey (phase II participants only) OTHER

-7 questions about the effectiveness of the life navigator

Phase 2:

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Kuroki L, Massad LS, Martin A, Liu J, Brown D, Leon A, Groesch K, Wilson T, Zeino Y, Diaz-Sylvester P, Delfino K, Hyon K, Kreuter M. Addressing Unmet Basic Needs to Improve Colposcopy Adherence Among Women With Abnormal Cervical Cancer Screening. J Low Genit Tract Dis. 2021 Apr 1;25(2):106-112. doi: 10.1097/LGT.0000000000000593.

  PMID: 33631781 DERIVED

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study Officials

• Lindsay M Kuroki, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 23, 2017
• Study Start: August 29, 2017
• Primary Completion: December 9, 2018
• Study Completion: December 9, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)