Trial Outcomes & Findings for Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate (NCT NCT05458960)
NCT ID: NCT05458960
Last Updated: 2026-08-31
Results Overview
TERMINATED
NA
3 participants
From enrollment through 6 weeks after enrollment
2026-08-31
Participant Flow
Participant milestones
| Measure |
Arm 3: Clinic Provider
4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.
|
Arm 1: Social Needs Navigator Program
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 2: Enhanced Usual Care
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Basic Needs Assessment and Support to Improve Colposcopy Show Rate
Baseline characteristics by cohort
| Measure |
Arm 1: Social Needs Navigator Program
n=2 Participants
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 2: Enhanced Usual Care
n=1 Participants
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
n=14 Participants
|
54 years
n=36 Participants
|
34 years
n=324 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=14 Participants
|
1 participants
n=36 Participants
|
3 participants
n=324 Participants
|
PRIMARY outcome
Timeframe: From enrollment through 6 weeks after enrollmentOutcome measures
| Measure |
Arm 3: Clinic Provider
n=2 Participants
4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.
|
Arm 2: Enhanced Usual Care
n=1 Participants
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.
|
|---|---|---|
|
Adherence to Colposcopy Visit as Measured as Number of Participants Who Complete Colposcopy Visit Within 6 Weeks After Enrollment
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 months after enrollment-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.
Outcome measures
| Measure |
Arm 3: Clinic Provider
n=2 Participants
4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.
|
Arm 2: Enhanced Usual Care
n=1 Participants
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.
|
|---|---|---|
|
Total Number of Unmet Basic Needs
|
2 number of unmet basic needs
Interval 1.0 to 3.0
|
1 number of unmet basic needs
Interval 1.0 to 1.0
|
SECONDARY outcome
Timeframe: Enrollment and 4 months after enrollmentParticipants 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.
Outcome measures
| Measure |
Arm 3: Clinic Provider
n=2 Participants
4 WUSM colposcopy providers, 4 staff members, and 1 community health worker will be surveyed to assess potential for dissemination.
|
Arm 2: Enhanced Usual Care
n=1 Participants
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.
|
|---|---|---|
|
Change in General Distress Score as Measured by the NCCN Distress Thermometer and Problem List
General distress score - enrollment
|
6 score on a scale
Interval 5.0 to 7.0
|
6 score on a scale
Interval 6.0 to 6.0
|
|
Change in General Distress Score as Measured by the NCCN Distress Thermometer and Problem List
General distress score - 4 months after enrollment
|
7.5 score on a scale
Interval 5.0 to 10.0
|
6 score on a scale
Interval 6.0 to 6.0
|
SECONDARY outcome
Timeframe: Completion of study enrollment (estimated to be 18 months)Population: Data was not collected for this outcome measure because there were no clinic providers enrolled.
-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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of study enrollment (estimated to be 18 months)Population: Data was not collected for this outcome measure due to study termination prior to participants' assessment at pre-specified time points.
-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?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of study enrollment (estimated to be 18 months)Population: Data was not collected for this outcome measure because no clinic providers were enrolled.
-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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of study enrollment (estimated to be 18 months)Population: Data was not collected for this outcome measure because there were not any clinic providers enrolled.
-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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Completion of study enrollment (estimated to be 18 months)Population: Data was not collected for this outcome measure because there were not any clinic providers enrolled.
-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.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Social Needs Navigator Program
Arm 2: Enhanced Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lindsay M. Kuroki
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place