Abnormal Pap SmearPhase 1NCT03317470
Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap
A Phase 1 study testing Basic needs survey, Life Navigator and Follow-up survey in people with Abnormal Pap Smear and Colposcopy, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap and effectively reduce disparities in cervical cancer risk and disease among rural and low-income urban women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abnormal Pap Smear, Colposcopy
- What is being tested?
- Basic needs survey, Life Navigator and Follow-up survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Aug 2017to 9 Dec 2018
- Phase
- Phase 1
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly referred patients to colposcopy clinic at SIUM and WUSM
- Aged 18 years or older
- English speaking
- Able to provide verbal consent
- Diagnosis of abnormal pap will be confirmed by pathology report
- Member of all races and ethnic groups
Who cannot join
- Male
- Established colposcopy clinic patients
- Known diagnosis of cancer
- Pregnancy
- Incarcerated
- Unable to consent
- No access to a working contact phone number
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Southern Illinois University School of Medicine
Springfield, Illinois, 62794
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap and effectively reduce disparities in cervical cancer risk and disease among rural and low-income urban women.
- Conditions
- Abnormal Pap Smear, Colposcopy
- Being tested
- Basic needs survey, Life Navigator, Follow-up survey, Follow-up survey (phase II participants only)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic needs surveyOther
-11 questions about food security, housing personal safety, neighborhood safety, childcare, and transportation
Life NavigatorBehavioural
- The life navigator will contact women identified with unmet basic needs within two business days of completing the baseline survey.
- The life navigator in our study will: (1) identify and assess women's needs; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help women access available resources by scheduling appointments and provide appointment reminders; (8) prepare women to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.
Follow-up surveyOther
-5 questions about the acceptability of the basic needs survey
Follow-up survey (phase II participants only)Other
-7 questions about the effectiveness of the life navigator
| Study group | Role | What they receive |
|---|---|---|
| Phase I: | Active comparator | * In Phase 1 of the study (first five months), the investigators will enroll new patients when they call them to remind them of their first colposcopy appointment. If patients consent, the investigators also will assess their basic needs during the call. Those who screen positive for at least one unmet basic need, will be referred to the 2-1-1 helpline at their clinic visit (or this information will be sent to them if they miss their clinic visit).
* All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
* For patients in phase 1, the follow-up survey will only assess acceptability of the basic needs survey (five questions) Receives: Other: Basic needs survey; Other: Follow-up survey |
| Phase 2: | Experimental | -In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey.
The life navigator will connect patients with community resources in each area to help with their unmet basic needs.
* All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit.
* Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator Receives: Other: Basic needs survey; Behavioral: Life Navigator; Other: Follow-up survey; Other: Follow-up survey (phase II participants only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant adherence to initial colposcopy visit
-Will use weekly clinic schedules to track adherence rates
Measured: At the time of initial colposcopy visit
Secondary outcomes (5)
Number of unmet basic needs
-Data obtained from Basic Needs Survey
Measured: -2 weeks prior to initial colposcopy visits
Type of unmet basic needs
-Data obtained from Basic Needs Survey
Measured: -2 weeks prior to initial colposcopy visits
Participant adherence to recommended follow-up after initial colposcopy visit
-Data will be collected for each participant to notate whether participant showed up for recommended follow-up visit and will be tabulated for all participants
Measured: At the time of initial colposcopy visit
Participant acceptability of the unmet basic needs survey
Measured: At the time of initial colposcopy visit
Participant perception of effectiveness of life navigator to assist with their unmet basic needs
- Data collected on the follow-up survey
- 7 questions asking the following
- Was the patient navigator helpful (yes with comments/no)
- What could the navigator done better (multiple choice and area to add comments)
- Did you use any of the resources the navigator told you about (yes with comments/no)
- Would you recommend this type of helper to a family member or friend (yes/no)
- Were there parts you didn't like or didn't find helpful (yes with comments/no)
- Do you think the patient navigator helped you get to your clinic appointments (yes/no)
- If available, would you find it helpful to talk to the patient navigator more (yes/no)
Measured: At the time of initial colposcopy visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start29 Aug 2017
- Primary completion9 Dec 2018
- Study completion9 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abnormal Pap SmearStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 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., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317470
- Sponsor's protocol ID
- 201708116
- Status last verified
- Jan 2019
- First submitted
- 9 Oct 2017
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuroki L, Massad LS, Martin A, Liu J, Brown D, Leon A, Groesch K, Wilson T, Zeino Y, Diaz-Sylvester P, Delfino K, Hyon K, Kreuter M. Addressing Unmet Basic Needs to Improve Colposcopy Adherence Among Women With Abnormal Cervical Cancer Screening. J Low Genit Tract Dis. 2021 Apr 1;25(2):106-112. doi: 10.1097/LGT.0000000000000593.
PubMed 33631781
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Unmet Basic Needs to Improve Adherence Among Women With an Abnormal Pap
- ClinicalTrials.gov ID
- NCT03317470
- Acronym / sponsor ID
- 201708116
- Conditions
- Abnormal Pap Smear, Colposcopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 9 Dec 2018 (actual)
- Study completion
- 9 Dec 2018 (actual)
- First posted
- 23 Oct 2017 (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.
The investigators aim to improve adherence to follow-up recommendations for an abnormal Pap and effectively reduce disparities in cervical cancer risk and disease among rural and low-income urban women.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I: | Active comparator | Other: Basic needs survey, Other: Follow-up survey* In Phase 1 of the study (first five months), the investigators will enroll new patients when they call them to remind them of their first colposcopy appointment. If patients consent, the investigators also will assess their basic needs during the call. Those who screen positive for at least one unmet basic need, will be referred to the 2-1-1 helpline at their clinic visit (or this information will be sent to them if they miss their clinic visit). * All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit. * For patients in phase 1, the follow-up survey will only assess acceptability of the basic needs survey (five questions) |
| Phase 2: | Experimental | Other: Basic needs survey, Behavioral: Life Navigator, Other: Follow-up survey, Other: Follow-up survey (phase II participants only)-In Phase 2 of the study (second five months), new colposcopy patients will be approached and consented in a similar fashion as in Phase 1 and asked to complete the basic needs survey. However, this time, patients who screen positive with at least one unmet basic need will be offered assistance by a life navigator (a trained case manager) who will contact the patients by phone within 2 business days of completing the survey. The life navigator will connect patients with community resources in each area to help with their unmet basic needs. * All women enrolled in our study will be asked to complete our basic needs survey and take a follow-up survey at the time of their first colposcopy visit. * Patients enrolled in phase 2 will be asked the same five questions in addition to seven more assessing perceived effectiveness of the life navigator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly referred patients to colposcopy clinic at SIUM and WUSM
- Aged 18 years or older
- English speaking
- Able to provide verbal consent
- Diagnosis of abnormal pap will be confirmed by pathology report
Key exclusion criteria (7 listed)
- Male
- Established colposcopy clinic patients
- Known diagnosis of cancer
- Pregnancy
- Incarcerated
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 |
|---|---|---|
| Basic needs survey-11 questions about food security, housing personal safety, neighborhood safety, childcare, and transportation | Other | Phase 2:, Phase I: |
| Life Navigator* The life navigator will contact women identified with unmet basic needs within two business days of completing the baseline survey. * The life navigator in our study will: (1) identify and assess women's needs; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help women access available resources by scheduling appointments and provide appointment reminders; (8) prepare women to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. | Behavioural | Phase 2: |
| Follow-up survey-5 questions about the acceptability of the basic needs survey | Other | Phase 2:, Phase I: |
| Follow-up survey (phase II participants only)-7 questions about the effectiveness of the life navigator | Other | Phase 2: |
Primary outcome
Participant adherence to initial colposcopy visit
Time frame: At the time of initial colposcopy visit
-Will use weekly clinic schedules to track adherence rates
5 secondary outcomes
Number of unmet basic needs
Time frame: -2 weeks prior to initial colposcopy visits
Type of unmet basic needs
Time frame: -2 weeks prior to initial colposcopy visits
Participant adherence to recommended follow-up after initial colposcopy visit
Time frame: At the time of initial colposcopy visit
Participant acceptability of the unmet basic needs survey
Time frame: At the time of initial colposcopy visit
Participant perception of effectiveness of life navigator to assist with their unmet basic needs
Time frame: At the time of initial colposcopy visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 33631781Kuroki L, Massad LS, Martin A, Liu J, Brown D, Leon A, Groesch K, Wilson T, Zeino Y, Diaz-Sylvester P, Delfino K, Hyon K, Kreuter M. Addressing Unmet Basic Needs to Improve Colposcopy Adherence Among Women With Abnormal Cervical Cancer Screening. J Low Genit Tract Dis. 2021 Apr 1;25(2):106-112. doi: 10.1097/LGT.0000000000000593.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Basic needs survey, Life Navigator and Follow-up survey in people with Abnormal Pap Smear and Colposcopy, run by Washington University School of Medicine at 2 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant adherence to initial colposcopy visit (time frame: At the time of initial colposcopy visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317470, which also lists 1 linked publication.
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 4 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.