ColposcopyNCT04704011
Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rates: The BASICS Trial
A study testing 2-1-1 United Way Healthy Missouri Hotline, National Comprehensive Cancer Network (NCCN) Distress Thermometer and Basic needs survey in people with Colposcopy, run by Washington University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Colposcopy
- What is being tested?
- 2-1-1 United Way Healthy Missouri Hotline, National Comprehensive Cancer Network (NCCN) Distress Thermometer and Basic needs survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- -≥ 21 years of age
- English speaking
- Able to provide verbal consent
Who cannot join
- Male
- Incarcerated
- Unable to consent
- Does not have access to a working contact phone number
About this study
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
- Being tested
- 2-1-1 United Way Healthy Missouri Hotline, National Comprehensive Cancer Network (NCCN) Distress Thermometer, Basic needs survey, 2-1-1 survey, Usual Care Reminder Call
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-1-1 United Way Healthy Missouri HotlineOther
This federally funded, free service connects callers with appropriate community services to help address their unmet basic needs.
National Comprehensive Cancer Network (NCCN) Distress ThermometerOther
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 surveyOther
11-item survey with questions regarding safety, housing, food, and financial needs
2-1-1 surveyOther
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 CallOther
-Automated phone call two weeks before their colposcopy appointment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care Reminder Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to colposcopy visit
Measured: Within 6 weeks of study enrollment
Secondary outcomes (5)
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.
Measured: At the time of enrollment; at least 2 weeks prior to colposcopy appointment
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.
Measured: At the time of enrollment
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
Measured: At the time of enrollment
Distress scores related to indications for colposcopy
-Score 0 (no distress) to 10 (severe distress)
Measured: At the time of enrollment
Patient self-reported use of 2-1-1 services as measured by 2-1-1 Survey
Measured: After or within 1 week after colposcopy visit (estimated to be 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start31 May 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Why it stopped: Trial was not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColposcopyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay M Kuroki, M.D., MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704011
- Sponsor's protocol ID
- 202010144
- Status last verified
- Jun 2022
- First submitted
- 7 Jan 2021
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rates: The BASICS Trial
- ClinicalTrials.gov ID
- NCT04704011
- Acronym / sponsor ID
- 202010144
- Conditions
- Colposcopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Trial was not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 31 May 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Basic Needs Assessment | Experimental | 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-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. |
| Arm 2: Usual Care Cohort | Active comparator | Other: Usual Care Reminder Call-Patients will receive an automated phone call two weeks before their colposcopy appointment to remind them of the date and time of their visit. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- -≥ 21 years of age
- English speaking
- Able to provide verbal consent
Key exclusion criteria (4 listed)
- Male
- Incarcerated
- Unable to consent
- Does not have access to a working contact phone number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-1-1 United Way Healthy Missouri HotlineThis federally funded, free service connects callers with appropriate community services to help address their unmet basic needs. | Other | Arm 1: Basic Needs Assessment |
| National Comprehensive Cancer Network (NCCN) Distress ThermometerStudy 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. | Other | Arm 1: Basic Needs Assessment |
| Basic needs survey11-item survey with questions regarding safety, housing, food, and financial needs | Other | Arm 1: Basic Needs Assessment |
| 2-1-1 surveyThis 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. | Other | Arm 1: Basic Needs Assessment |
| Usual Care Reminder Call-Automated phone call two weeks before their colposcopy appointment | Other | Arm 2: Usual Care Cohort |
Primary outcome
Adherence to colposcopy visit
Time frame: Within 6 weeks of study enrollment
5 secondary outcomes
Number and type of unmet basic needs as measured by Unmet Basic Needs Survey
Time frame: At the time of enrollment; at least 2 weeks prior to colposcopy appointment
General distress scores as measured by NCCN Distress Thermometer
Time frame: At the time of enrollment
Causes of distress as measured by NCCN Distress Problem List
Time frame: At the time of enrollment
Distress scores related to indications for colposcopy
Time frame: At the time of enrollment
Patient self-reported use of 2-1-1 services as measured by 2-1-1 Survey
Time frame: After or within 1 week after colposcopy visit (estimated to be 6 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay M Kuroki, M.D., MSCI principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing 2-1-1 United Way Healthy Missouri Hotline, National Comprehensive Cancer Network (NCCN) Distress Thermometer and Basic needs survey in people with Colposcopy, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to colposcopy visit (time frame: Within 6 weeks of study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.