Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rates: The BASICS Trial

Not Applicable

Withdrawn

• Conditions: Colposcopy

• Registration Number: NCT04704011
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This randomized controlled, single-site study hopes to determine the effectiveness of a tailored phone call reminder to improve low-income patients' adherence to colposcopy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Study Start: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-29
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Female

  -≥ 21 years of age

• English speaking

• Able to provide verbal consent

Exclusion Criteria

• Male
• Incarcerated
• Unable to consent
• Does not have access to a working contact phone number

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to colposcopy visit	Within 6 weeks of study enrollment

Secondary Outcome Measures

Name	Time	Method
Distress scores related to indications for colposcopy	At the time of enrollment	-Score 0 (no distress) to 10 (severe distress)
Patient self-reported use of 2-1-1 services as measured by 2-1-1 Survey	After or within 1 week after colposcopy visit (estimated to be 6 weeks)
General distress scores as measured by NCCN Distress Thermometer	At the time of enrollment	-Participant is asked to circle the number from 0-10 that best describes how much distress the participant has experienced in the past week. 0=no distress and 10=extreme distress.
Number and type of unmet basic needs as measured by Unmet Basic Needs Survey	At the time of enrollment; at least 2 weeks prior to colposcopy appointment	-Questions asking participant about food security, housing, personal safety, neighborhood safety, sufficient money for necessities, childcare, and transportation. Scored bases on participant' self-perceived likelihood that their safety, housing, food, and financial needs would be met in the next month.
Causes of distress as measured by NCCN Distress Problem List	At the time of enrollment	-39 questions asking participant to answer yes or no to problems (practical, family, emotional, spiritual/religious, and physical) that they have experienced in the past week