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

Study Overview
=================
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.

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Basic Needs Assessment<br>-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<br>* This federally funded, free service connects callers with appropriate community services to help address their unmet basic needs.<br>Other: National Comprehensive Cancer Network (NCCN) Distress Thermometer<br>* 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.<br>Other: Basic needs survey<br>* 11-item survey with questions regarding safety, housing, food, and financial needs<br>Other: 2-1-1 survey<br>* 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.<br>|
| Active Comparator: Arm 2: Usual Care Cohort<br>-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<br>* -Automated phone call two weeks before their colposcopy appointment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |