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

Colposcopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317470
• Other study ID #: 201708116
• Status: Completed
• Phase: Phase 1
• Start date: August 29, 2017
• Est. completion date: December 9, 2018

Study information

• Verified date: January 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 9, 2018
• Est. primary completion date: December 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Pap Smear
• Colposcopy

Intervention

Other:
• Basic needs survey
-11 questions about food security, housing personal safety, neighborhood safety, childcare, and transportation

Behavioral:
• Life Navigator
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.

Other:
• Follow-up survey
-5 questions about the acceptability of the basic needs survey
• Follow-up survey (phase II participants only)
-7 questions about the effectiveness of the life navigator

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Southern Illinois University School of Medicine	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant adherence to initial colposcopy visit	-Will use weekly clinic schedules to track adherence rates	At the time of initial colposcopy visit
Secondary	Number of unmet basic needs	-Data obtained from Basic Needs Survey	-2 weeks prior to initial colposcopy visits
Secondary	Type of unmet basic needs	-Data obtained from Basic Needs Survey	-2 weeks prior to initial colposcopy visits
Secondary	Participant adherence to recommended follow-up after 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	At the time of initial colposcopy visit
Secondary	Participant acceptability of the unmet basic needs survey		At the time of initial colposcopy visit
Secondary	Participant perception of effectiveness of life navigator to assist with their unmet basic needs	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)	At the time of initial colposcopy visit

External Links

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