Women Helping Women - Lung Cancer Screening

NCT ID: NCT04983134

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-19
• Study Completion Date: 2021-12-20

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

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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;

Group Type: NO_INTERVENTION

No interventions assigned to this group

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);

Group Type: EXPERIMENTAL

Enhanced CHW Intervention

Intervention Type: BEHAVIORAL

community-based intervention

Interventions

Enhanced CHW Intervention

community-based intervention

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UF Health Cancer Center

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202100009

Identifier Type: OTHER

Identifier Source: secondary_id

OCR40152

Identifier Type: -

Identifier Source: org_study_id