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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colposcopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

2-1-1 United Way Healthy Missouri Hotline

Intervention Type OTHER

This federally funded, free service connects callers with appropriate community services to help address their unmet basic needs.

National Comprehensive Cancer Network (NCCN) Distress Thermometer

Intervention Type OTHER

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.

Basic needs survey

Intervention Type OTHER

11-item survey with questions regarding safety, housing, food, and financial needs

2-1-1 survey

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Usual Care Reminder Call

Intervention Type OTHER

-Automated phone call two weeks before their colposcopy appointment

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Basic needs survey

11-item survey with questions regarding safety, housing, food, and financial needs

Intervention Type 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.

Intervention Type OTHER