Cervical CancerBASICSNCT05458960
Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate
A study testing Social needs navigator program in people with Cervical Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. Read more about this study
- Who is it for?
- Ages 21 to 90 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Social needs navigator program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2025to 17 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abnormal cervical cancer screen
- Missed appointment at BJH colposcopy clinic and need to reschedule
- Age 21 years or older
- Able to provide verbal consent
- Diagnosis of an abnormal cervical screen confirmed by cytology or pathology
Who cannot join
- Individual without a cervix
- Known diagnosis or history of cancer
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate: The BASICS Trial
The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).
- Conditions
- Cervical Cancer
- Being tested
- Social needs navigator program, Enhanced usual care
- Keywords
- Colposcopy, Cervical cancer prevention, Adherence to follow-up, Unmet social needs, Distress
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social needs navigator programBehavioural
4 months of assistance tailored to the needs of the participant
Enhanced usual careBehavioural
Referral to United Way 2-1-1
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Social needs navigator program | Experimental | Participants will be paired with a community health worker who will provide tailored support to address unmet social needs. The number and frequency of calls will be limited only by participants' needs, interest, and willingness to interact. The type of contact could include phone calls, or home/community visits. The community health worker will: (1) identify and assess patients' unmet social needs; (2) jointly generate solutions; (3) help prioritize among multiple needs; (4) identify community resources that could help resolve the problem(s); (5) determine eligibility for services; (6) help patients access available resources by scheduling appointments and providing appointment reminders; (7) prepare patients to interact with service agencies and/or act as an advocate; (8) provide support such as arranging transportation; (9) oversee follow-up problem-solving actions; and (10) review progress made towards resolving unmet social needs and adapt solutions. Receives: Behavioral: Social needs navigator program |
| Arm 2: Enhanced usual care | Active comparator | Participants will receive verbal referral to a federally funded, free, 24-hr assistance hotline, United Way 2-1-1, which connects callers with community services to help address unmet social needs. Receives: Behavioral: Enhanced usual care |
| Arm 3: Clinic provider | No intervention | 4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Colposcopy Visit as Measured as Number of Participants Who Complete Colposcopy Visit Within 6 Weeks After Enrollment
Measured: From enrollment through 6 weeks after enrollment
Secondary outcomes (7)
Total Number of Unmet Basic Needs
-Unmet basic needs include food security, housing, personal safety, neighborhood safety, sufficient money for necessities, childcare (if applicable), and transportation. A questionnaire will be given to participants to identify the number of unmet basic needs the participant has.
Measured: 4 months after enrollment
Change in General Distress Score as Measured by the NCCN Distress Thermometer and Problem List
Participants will be asked to rate the amount of distress (scale of 0 to 10, 10=extreme distress) that they have experienced in the past week and the amount of distress (scale of 0 to 10) that they attribute to their abnormal cervical cancer screen. The NCCN distress problem list is a 40-item list categorized into five themes-practical, family, emotional, spiritual, and physical problems¬-and leaves room for patients to describe "other". A higher score indicates the greater the amount of distress.
Measured: Enrollment and 4 months after enrollment
Intent to Use Intervention Over Time
-Providers are asked after completion of enrollment to indicate on a scale of 1=not committed to 10=fully committed of how committed they are to use the intervention in their clinic.
Measured: Completion of study enrollment (estimated to be 18 months)
Patients' Satisfaction With Intervention
-The interview guide has two questions that relate to patient satisfaction related to the intervention. 1) Was the [community health worker or 2-1-1 operator] helpful to you? 2) Would you recommend [the community healthworker/2-1-1] to a family member or friend?
Measured: Completion of study enrollment (estimated to be 18 months)
Providers' Satisfaction With Intervention
-Providers are asked after completion of enrollment to indicate their satisfaction with the intervention. They are given 12 statements about the satisfaction of the intervention and are asked to circle responses of 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, or 5=completely agree. The higher the score the more satisfied the provider is with the intervention.
Measured: Completion of study enrollment (estimated to be 18 months)
Resources Needed to Sustain Intervention
-Validated questionnaire that will be administered to providers, staff, and community health workers: Self-administered 15-minute online survey that will be completed at the end of the study enrollment period. The survey will ask about specific implementation outcomes using the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure.
Measured: Completion of study enrollment (estimated to be 18 months)
Likelihood That Intervention Will Become Built Into Usual Care
-Providers are asked after completion of enrollment to indicate the likelihood that the intervention can be built into usual care in their clinic. The responses are either likely, very likely, neutral, unlikely, very unlikely, or unsure.
Measured: Completion of study enrollment (estimated to be 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start28 Mar 2025
- Primary completion28 Aug 2025
- Study completion17 Nov 2025
Why it stopped: Staffing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Lindsay M Kuroki, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458960
- Sponsor's protocol ID
- 202205183
- Other IDs
- 1R03TR004017-01A1
- Acronym
- BASICS
- Status last verified
- Aug 2026
- First submitted
- 8 Jul 2022
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 31 Aug 2026. 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 Rate: The BASICS Trial
- ClinicalTrials.gov ID
- NCT05458960
- Acronym / sponsor ID
- BASICS / 202205183
- Conditions
- Cervical Cancer
- Keywords
- Colposcopy, Cervical cancer prevention, Adherence to follow-up, Unmet social needs, Distress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staffing issues
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will perform a randomized controlled trial in which 72 eligible patients (low-income, uninsured, or on Medicaid) who are referred for colposcopy at Washington University School of Medicine, are enrolled and then screened for unmet social needs and distress. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Social needs navigator program | Experimental | Behavioral: Social needs navigator programParticipants will be paired with a community health worker who will provide tailored support to address unmet social needs. The number and frequency of calls will be limited only by participants' needs, interest, and willingness to interact. The type of contact could include phone calls, or home/community visits. The community health worker will: (1) identify and assess patients' unmet social needs; (2) jointly generate solutions; (3) help prioritize among multiple needs; (4) identify community resources that could help resolve the problem(s); (5) determine eligibility for services; (6) help patients access available resources by scheduling appointments and providing appointment reminders; (7) prepare patients to interact with service agencies and/or act as an advocate; (8) provide support such as arranging transportation; (9) oversee follow-up problem-solving actions; and (10) review progress made towards resolving unmet social needs and adapt solutions. |
| Arm 2: Enhanced usual care | Active comparator | Behavioral: Enhanced usual careParticipants will receive verbal referral to a federally funded, free, 24-hr assistance hotline, United Way 2-1-1, which connects callers with community services to help address unmet social needs. |
| Arm 3: Clinic provider | No intervention | –4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Abnormal cervical cancer screen
- Missed appointment at BJH colposcopy clinic and need to reschedule
- Age 21 years or older
- Able to provide verbal consent
- Diagnosis of an abnormal cervical screen confirmed by cytology or pathology
Key exclusion criteria (3 listed)
- Individual without a cervix
- Known diagnosis or history of cancer
- Unable to consent
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 |
|---|---|---|
| Social needs navigator program4 months of assistance tailored to the needs of the participant | Behavioural | Arm 1: Social needs navigator program |
| Enhanced usual careReferral to United Way 2-1-1 | Behavioural | Arm 2: Enhanced usual care |
Primary outcome
Adherence to Colposcopy Visit as Measured as Number of Participants Who Complete Colposcopy Visit Within 6 Weeks After Enrollment
Time frame: From enrollment through 6 weeks after enrollment
7 secondary outcomes
Total Number of Unmet Basic Needs
Time frame: 4 months after enrollment
Change in General Distress Score as Measured by the NCCN Distress Thermometer and Problem List
Time frame: Enrollment and 4 months after enrollment
Intent to Use Intervention Over Time
Time frame: Completion of study enrollment (estimated to be 18 months)
Patients' Satisfaction With Intervention
Time frame: Completion of study enrollment (estimated to be 18 months)
Providers' Satisfaction With Intervention
Time frame: Completion of study enrollment (estimated to be 18 months)
Resources Needed to Sustain Intervention
Time frame: Completion of study enrollment (estimated to be 18 months)
Likelihood That Intervention Will Become Built Into Usual Care
Time frame: Completion of study enrollment (estimated to be 18 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social needs navigator program in people with Cervical Cancer, run by Washington University School of Medicine at 1 site in United States.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 as Measured as Number of Participants Who Complete Colposcopy Visit Within 6 Weeks After Enrollment (time frame: From enrollment through 6 weeks after 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 31 Aug 2026.