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

Colposcopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04704011
• Other study ID #: 202010144
• Status: Withdrawn
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colposcopy

Intervention

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.
• 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.
• Basic needs survey
11-item survey with questions regarding safety, housing, food, and financial needs
• 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.
• Usual Care Reminder Call
-Automated phone call two weeks before their colposcopy appointment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to colposcopy visit		Within 6 weeks of study enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	Distress scores related to indications for colposcopy	-Score 0 (no distress) to 10 (severe distress)	At the time of enrollment
Secondary	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)

External Links

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