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Women Helping Women - Lung Cancer Screening

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced CHW Intervention
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women who are 50 to 80 years old
  • 20+ pack-years of smoking history
  • live within 45 miles of UF Health Shands Hospital or in Duval County, specifically the 12,000+ HealthStreet cohort

Exclusion Criteria:

  • women outside the acceptable age range
  • insufficient smoking history
  • women who live outside the 45 miles of UF Health Shands Hosptial or not in Duval County not in the HealthStreet system

Sites / Locations

  • UF Health Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Intervention(SI)

Enhanced CHW Intervention

Arm Description

the HealthStreet Standard Intervention to include a CHW referral to an accessible and acceptable lung cancer screening site to include a financial counselor (if needed), tobacco cessation and quit resources (if still smoking) and, additionally, will watch the Genentech lung cancer screening video with the CHW;

After 1:1 randomization, 30 women will additionally receive a 6-hour four week Enhanced CHW Intervention (E-CHW-I) modelled on successful peer-partnered interventions and informed by Stages of Change theory, which will add to the SI, calls and texts (if appropriate) to help problem solve and encourage screening receipt and transportation to the screening (if needed);

Outcomes

Primary Outcome Measures

Feasibility of Recruitment - Degree of Agreement Measured with Likert Scale
Feasibility of recruiting occurs with the Baseline Assessment which will assess participants' degree of agreement with their readiness to receive lung cancer screening on a 10 point Likert scale (strongly disagree through strongly agree) mirroring those used to assess readiness for breast and colorectal cancer screening
Feasibility of Implementation - screening adherence with Community Health Worker
to test the feasibility of implementation of a customize culturally relevant, gender-specific Community Health Worker partnered intervention using the Transtheoretical Stages of Change model, the investigators will measure screening adherence in hours for lung cancer among the 60 women assessed through records of intervention delivery, including Randomization and Contact Logs, where the investigators will document each contact with the 60 women enrolled.
Evaluation of Efficacy - number of participants who engaged in a referred screening service
to evaluate the limited efficacy of the WHW-L intervention to increase screening for lung cancer among the 60 women at 45 days to improve outcome variables: see physician re lung cancer screening/smoking, schedule screening, receive screening, the investigators will conduct phone-based follow-up interviews among all 60 women at 45 days.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2021
Last Updated
May 9, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04983134
Brief Title
Women Helping Women - Lung Cancer Screening
Official Title
Women Helping Women Lung Cancer Screening (WHW-L)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

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 Women Helping Women Lung Cancer Screening (WHW-L) Study will be conducted to develop a scalable, easy to apply community-based intervention to increase rates of lung cancer screening and follow-up in high-need/low-resource populations, based on a Transtheoretical Stages of Change theoretical model. The investigators will test the feasibility of using Community Health Workers to recruit (Aim 1) and partner with 60 community members (Aim 2) within 6 months, to take the steps to consult with a doctor, schedule screening, and/or attend screening (Aim 3) [84 people may be screened for the study assuming some don't continue}.CHWs will use the HealthStreet 12,000+ cohort to identify current or former female smokers (adults 50 to 77 years old) with a smoking history of 25 pack-years who could benefit from LDCT screening for lung cancer and will facilitate steps in their screening receipt. All participants will benefit from the Standard Intervention; additionally, a random sample of 30 will receive the Enhanced CHW Intervention (E-CHW-I). The investigators hypothesize that women who may be at higher risk of lung cancer due to lack of knowledge, access, and resources will take steps to receipt of LDCT in both interventions, with those receiving the Enhanced Intervention more likely to take these steps. Ultimately, such an intervention could lead to a lower lung cancer burden in the target population

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Intervention(SI)
Arm Type
No Intervention
Arm Description
the HealthStreet Standard Intervention to include a CHW referral to an accessible and acceptable lung cancer screening site to include a financial counselor (if needed), tobacco cessation and quit resources (if still smoking) and, additionally, will watch the Genentech lung cancer screening video with the CHW;
Arm Title
Enhanced CHW Intervention
Arm Type
Experimental
Arm Description
After 1:1 randomization, 30 women will additionally receive a 6-hour four week Enhanced CHW Intervention (E-CHW-I) modelled on successful peer-partnered interventions and informed by Stages of Change theory, which will add to the SI, calls and texts (if appropriate) to help problem solve and encourage screening receipt and transportation to the screening (if needed);
Intervention Type
Behavioral
Intervention Name(s)
Enhanced CHW Intervention
Intervention Description
community-based intervention
Primary Outcome Measure Information:
Title
Feasibility of Recruitment - Degree of Agreement Measured with Likert Scale
Description
Feasibility of recruiting occurs with the Baseline Assessment which will assess participants' degree of agreement with their readiness to receive lung cancer screening on a 10 point Likert scale (strongly disagree through strongly agree) mirroring those used to assess readiness for breast and colorectal cancer screening
Time Frame
at baseline visit
Title
Feasibility of Implementation - screening adherence with Community Health Worker
Description
to test the feasibility of implementation of a customize culturally relevant, gender-specific Community Health Worker partnered intervention using the Transtheoretical Stages of Change model, the investigators will measure screening adherence in hours for lung cancer among the 60 women assessed through records of intervention delivery, including Randomization and Contact Logs, where the investigators will document each contact with the 60 women enrolled.
Time Frame
At 4 weeks after intervention completion
Title
Evaluation of Efficacy - number of participants who engaged in a referred screening service
Description
to evaluate the limited efficacy of the WHW-L intervention to increase screening for lung cancer among the 60 women at 45 days to improve outcome variables: see physician re lung cancer screening/smoking, schedule screening, receive screening, the investigators will conduct phone-based follow-up interviews among all 60 women at 45 days.
Time Frame
after intervention completion, at the 45-day follow up call

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women who are 50 to 80 years old 20+ pack-years of smoking history live within 45 miles of UF Health Shands Hospital or in Duval County, specifically the 12,000+ HealthStreet cohort Exclusion Criteria: women outside the acceptable age range insufficient smoking history women who live outside the 45 miles of UF Health Shands Hosptial or not in Duval County not in the HealthStreet system
Facility Information:
Facility Name
UF Health Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Women Helping Women - Lung Cancer Screening

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