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

NCT04704011 | Withdrawn

• 1 other identifier: 202010144
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colposcopy

Outcome Measures

Primary Outcomes (1)

• Adherence to colposcopy visit

  Within 6 weeks of study enrollment

Secondary Outcomes (5)

• 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

• General distress scores as measured by NCCN Distress Thermometer

  At the time of enrollment

• Causes of distress as measured by NCCN Distress Problem List

  At the time of enrollment

• Distress scores related to indications for colposcopy

  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)

Study Arms (2)

Arm 1: Basic Needs Assessment

EXPERIMENTAL

-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; Other: National Comprehensive Cancer Network (NCCN) Distress Thermometer; Other: Basic needs survey; Other: 2-1-1 survey

Arm 2: Usual Care Cohort

ACTIVE COMPARATOR

-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

Interventions

2-1-1 United Way Healthy Missouri Hotline OTHER

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

Arm 1: Basic Needs Assessment

National Comprehensive Cancer Network (NCCN) Distress Thermometer 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.

Arm 1: Basic Needs Assessment

Basic needs survey OTHER

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

Arm 1: Basic Needs Assessment

2-1-1 survey 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 1: Basic Needs Assessment

Usual Care Reminder Call OTHER

-Automated phone call two weeks before their colposcopy appointment

Arm 2: Usual Care Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• ≥ 21 years of age
• English speaking
• Able to provide verbal consent

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

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

Study Officials

• Lindsay M Kuroki, M.D., MSCI

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: May 31, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share