Colposcopy Clinical Trial
Official title:
Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rates: The BASICS Trial
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Status | Withdrawn |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 |
Verified date | June 2022 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
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) |
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