Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04704011
Other study ID # 202010144
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT03701347 - A Comparison of Three Simulators for Colposcopy LEEP Training N/A
Completed NCT03100565 - Lidocaine Spray vs Coughing for Pain Relief During Colposcopy N/A
Completed NCT00839475 - Investigation of the Uterine Cervix Using CervicalMD N/A
Recruiting NCT06149598 - Coughing at Time of Cervical Biopsy N/A
Completed NCT01214304 - Aromatherapy to Reduce Pain and Anxiety During Cervical Colposcopy N/A
Completed NCT03317470 - Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap Phase 1
Recruiting NCT05281939 - Multi-center Application of an AI System for Diagnosis of Cervical Lesions Based on Colposcopy Images N/A
Completed NCT00474968 - Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique. N/A
Completed NCT00941512 - High Resolution Digital Imaging of the Uterine Cervix N/A
Completed NCT03464552 - Celecoxib in Colposcopic Directed Biopsy Phase 4