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

Not Applicable

Withdrawn

• Conditions: Colposcopy
• Interventions: Other: Usual Care Reminder Call; Other: 2-1-1 United Way Healthy Missouri Hotline; Other: National Comprehensive Cancer Network (NCCN) Distress Thermometer; Other: Basic needs survey; Other: 2-1-1 survey

• 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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Arm 1: Basic Needs Assessment	National Comprehensive Cancer Network (NCCN) Distress Thermometer	-Patients will receive a phone call from a research team member 2-4 weeks before their colposcopy appointment. The team member will remind the patient of the date and time of their appointment and conduct a basic needs assessment. Those who have at least one unmet basic need or are unsure of their current needs will be referred to the 24-hr assistance hotline, 2-1-1 United Healthy Way Missouri. After the date of their appointment, patients will be contacted to ask whether they contacted 2-1-1 and used any recommended services.
Arm 1: Basic Needs Assessment	Basic needs survey	-Patients will receive a phone call from a research team member 2-4 weeks before their colposcopy appointment. The team member will remind the patient of the date and time of their appointment and conduct a basic needs assessment. Those who have at least one unmet basic need or are unsure of their current needs will be referred to the 24-hr assistance hotline, 2-1-1 United Healthy Way Missouri. After the date of their appointment, patients will be contacted to ask whether they contacted 2-1-1 and used any recommended services.
Arm 2: Usual Care Cohort	Usual Care Reminder Call	-Patients will receive an automated phone call two weeks before their colposcopy appointment to remind them of the date and time of their visit.
Arm 1: Basic Needs Assessment	2-1-1 United Way Healthy Missouri Hotline	-Patients will receive a phone call from a research team member 2-4 weeks before their colposcopy appointment. The team member will remind the patient of the date and time of their appointment and conduct a basic needs assessment. Those who have at least one unmet basic need or are unsure of their current needs will be referred to the 24-hr assistance hotline, 2-1-1 United Healthy Way Missouri. After the date of their appointment, patients will be contacted to ask whether they contacted 2-1-1 and used any recommended services.
Arm 1: Basic Needs Assessment	2-1-1 survey	-Patients will receive a phone call from a research team member 2-4 weeks before their colposcopy appointment. The team member will remind the patient of the date and time of their appointment and conduct a basic needs assessment. Those who have at least one unmet basic need or are unsure of their current needs will be referred to the 24-hr assistance hotline, 2-1-1 United Healthy Way Missouri. After the date of their appointment, patients will be contacted to ask whether they contacted 2-1-1 and used any recommended services.

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