Colposcopy
Conditions
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.
Interventions
OTHERBasic needs survey
11-item survey with questions regarding safety, housing, food, and financial needs
OTHER2-1-1 United Way Healthy Missouri Hotline
This federally funded, free service connects callers with appropriate community services to help address their unmet basic needs.
OTHERNational 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.
OTHER2-1-1 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.
OTHERUsual Care Reminder Call
-Automated phone call two weeks before their colposcopy appointment
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence to colposcopy visit | Within 6 weeks of study enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | -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. |
| General distress scores as measured by NCCN Distress Thermometer | At the time of enrollment | -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. |
| Causes of distress as measured by NCCN Distress Problem List | At the time of enrollment | -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 |
| Distress scores related to indications for colposcopy | At the time of enrollment | -Score 0 (no distress) to 10 (severe distress) |
| 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) | — |
Outcome results
None listed