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Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate (BASICS)

Primary Purpose

Cervical Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social needs navigator program
Enhanced usual care
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring Colposcopy, Cervical cancer prevention, Adherence to follow-up, Unmet social needs, Distress

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Abnormal cervical cancer screen
  • Missed appointment at WUSM colposcopy clinic and need to reschedule
  • Age 21 years or older
  • English-speaking
  • Able to provide verbal consent
  • Diagnosis of an abnormal cervical screen confirmed by cytology or pathology

Exclusion Criteria:

  • Individual without a cervix
  • Known diagnosis or history of cancer
  • Unable to consent

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Arm 1: Social needs navigator program

Arm 2: Enhanced usual care

Arm 3: Clinic provider

Arm Description

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.

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.

4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.

Outcomes

Primary Outcome Measures

Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit

Secondary Outcome Measures

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.
Change in general distress scores 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".
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.
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?
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.
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.
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.

Full Information

First Posted
July 8, 2022
Last Updated
September 7, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05458960
Brief Title
Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate
Acronym
BASICS
Official Title
Evaluating the Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate: The BASICS Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. The participants will then be randomized 1:1 into either receive the social needs navigator program (n=36) or enhanced usual care (n=36).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Colposcopy, Cervical cancer prevention, Adherence to follow-up, Unmet social needs, Distress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Social needs navigator program
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 2: Enhanced usual care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm 3: Clinic provider
Arm Type
No Intervention
Arm Description
4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.
Intervention Type
Behavioral
Intervention Name(s)
Social needs navigator program
Intervention Description
4 months of assistance tailored to the needs of the participant
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Intervention Description
Referral to United Way 2-1-1
Primary Outcome Measure Information:
Title
Adherence to colposcopy visit as measured as number of participants who complete colposcopy visit
Time Frame
6 weeks after enrollment
Secondary Outcome Measure Information:
Title
Total number of unmet basic needs
Description
-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.
Time Frame
4 months after enrollment
Title
Change in general distress scores as measured by the NCCN Distress Thermometer and Problem List
Description
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".
Time Frame
Enrollment and 4 months after enrollment
Title
Intent to use intervention over time
Description
-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.
Time Frame
Completion of study enrollment (estimated to be 18 months)
Title
Patients' satisfaction with intervention
Description
-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?
Time Frame
Completion of study enrollment (estimated to be 18 months)
Title
Providers' satisfaction with intervention
Description
-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.
Time Frame
Completion of study enrollment (estimated to be 18 months)
Title
Resources needed to sustain intervention
Description
-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.
Time Frame
Completion of study enrollment (estimated to be 18 months)
Title
Likelihood that intervention will become built into usual care
Description
-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.
Time Frame
Completion of study enrollment (estimated to be 18 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Abnormal cervical cancer screen Missed appointment at WUSM colposcopy clinic and need to reschedule Age 21 years or older English-speaking Able to provide verbal consent Diagnosis of an abnormal cervical screen confirmed by cytology or pathology Exclusion Criteria: Individual without a cervix Known diagnosis or history of cancer Unable to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay M Kuroki, M.D.
Phone
314-362-2368
Email
kurokil@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay M Kuroki, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay M Kuroki, M.D.
Phone
314-362-2368
Email
kurokil@wustl.edu
First Name & Middle Initial & Last Name & Degree
Lindsay M Kuroki, M.D.
First Name & Middle Initial & Last Name & Degree
L. Stewart Massad, M.D.
First Name & Middle Initial & Last Name & Degree
Mary Mullen, M.D.
First Name & Middle Initial & Last Name & Degree
Andrea Hagemann, M.D.
First Name & Middle Initial & Last Name & Degree
David G Mutch, M.D.
First Name & Middle Initial & Last Name & Degree
Matthew A Powell, M.D.
First Name & Middle Initial & Last Name & Degree
Premal H Thaker, M.D., M.S.
First Name & Middle Initial & Last Name & Degree
Carolyn K McCourt, M.D.
First Name & Middle Initial & Last Name & Degree
Dineo Khabele, M.D.
First Name & Middle Initial & Last Name & Degree
Esther Lu, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate

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