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

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.

Study Overview

• Status: Withdrawn
• Conditions: Colposcopy
• Intervention / Treatment: 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; Other: Usual Care Reminder Call

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Basic Needs Assessment; -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.	Other: 2-1-1 United Way Healthy Missouri Hotline; This federally funded, free service connects callers with appropriate community services to help address their unmet basic needs.; Other: National Comprehensive Cancer Network (NCCN) Distress Thermometer; Study participants will be asked to rate the amount of distress that they have experienced in the past week (scale of 0 to 10, 10=extreme distress) and indicate areas of concern including practical basic needs and family, emotional, spiritual, and physical problems. They will also be asked to rate the amount of distress (scale 0-10) that they attribute to their abnormal cervical cancer screen.; Other: Basic needs survey; 11-item survey with questions regarding safety, housing, food, and financial needs; Other: 2-1-1 survey; This brief, 5-minute survey will be performed either in person or by phone after the participants arrive to their colposcopy appointment or after 6 weeks of their scheduled visit if they are nonadherent. The research team will ask patients regarding any changes in the status of their unmet basic needs (resolved, improved, worsened, or stayed the same) and how useful they found the 2-1-1 resource.
Active Comparator: Arm 2: Usual Care Cohort; -Patients will receive an automated phone call two weeks before their colposcopy appointment to remind them of the date and time of their visit.	Other: Usual Care Reminder Call; -Automated phone call two weeks before their colposcopy appointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adherence to colposcopy visit	Within 6 weeks of study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and type of unmet basic needs as measured by Unmet Basic Needs Survey	-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.	At the time of enrollment; at least 2 weeks prior to colposcopy appointment
General distress scores as measured by NCCN Distress Thermometer	-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.	At the time of enrollment
Causes of distress as measured by NCCN Distress Problem List	-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	At the time of enrollment
Distress scores related to indications for colposcopy	-Score 0 (no distress) to 10 (severe distress)	At the time of enrollment
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Lindsay M Kuroki, M.D., MSCI, Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 31, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202010144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No