Women Helping Women - Lung Cancer Screening

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04983134
Collaborator
(none)
60
1
2
35.4
1.7

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Enhanced CHW Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Women Helping Women Lung Cancer Screening (WHW-L)
Actual Study Start Date :
Apr 19, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Intervention(SI)

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;

Experimental: Enhanced CHW Intervention

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);

Behavioral: Enhanced CHW Intervention
community-based intervention

Outcome Measures

Primary Outcome Measures

  1. Feasibility of Recruitment - Degree of Agreement Measured with Likert Scale [at baseline visit]

    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

  2. Feasibility of Implementation - screening adherence with Community Health Worker [At 4 weeks after intervention completion]

    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.

  3. Evaluation of Efficacy - number of participants who engaged in a referred screening service [after intervention completion, at the 45-day follow up call]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UF Health Cancer Center Gainesville Florida United States 32610

Sponsors and Collaborators

  • University of Florida

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT04983134
Other Study ID Numbers:
  • OCR40152
  • IRB202100009
First Posted:
Jul 30, 2021
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021