Project PLUS Lung Cancer Screening Promotion

Project PLUS- Promoting Lung Cancer Screening Among Screening-Eligible Individuals in Environmentally Burdened Communities Through Enhanced Risk Communication

Project PLUS is a pilot study that aims to develop and obtain preliminary feasibility and efficacy data on an enhanced risk communication approach to promote lung cancer screening (LCS) intentions among screening-eligible individuals from environmentally burdened communities. Project PLUS will combine qualitative interviews to explore subject awareness regarding lung cancer risk and air pollution, barriers to LCS, and perceptions regarding risk communication messaging, develop a health education video, and a between-subjects experiment to compare Data from this pilot will form the basis for enhanced community engagement efforts and subsequent communication research to examine the effectiveness of incorporating the involuntary air pollution risk information in risk communication interventions. The long term goal is to reduce lung cancer burden and disparities among environmentally burdened communities within and outside of Philadelphia.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Intervention video; Behavioral: Control video

Detailed Description

Project PLUS is a pilot study that aims to develop and obtain preliminary feasibility and efficacy data on an enhanced risk communication approach to promote lung cancer screening (LCS) intentions among screening-eligible individuals from environmentally burdened communities. Project PLUS will combine qualitative interviews to explore subject awareness regarding lung cancer risk and air pollution, barriers to LCS, and perceptions regarding risk communication messaging, develop a health education video, and a between-subjects experiment to compare Data from this pilot will form the basis for enhanced community engagement efforts and subsequent communication research to examine the effectiveness of incorporating the involuntary air pollution risk information in risk communication interventions. The long term goal is to reduce lung cancer burden and disparities among environmentally burdened communities within and outside of Philadelphia.

This study is guided by the Health Belief Model and the Reasoned Action Approach.1 The study team will engage with two community partner organizations (Chester Environmental Partnership and Clean Water Action) to obtain feedback in implementing the study procedures and input on content for the health education video. The long-term goal is to improve LCS and reduce racial, ethnic, and socioeconomic disparities in lung cancer mortality.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient interview participants will be eligible if they:

1. Are ages 50 - 80 years;
2. Have a history of at least 20 cigarette pack-years, and who have quit within the past 15 years or are currently smoking;
3. Had a primary care visit at Penn Medicine within the last two years (2020-2021);
4. Have documented history of lung cancer screening or lung cancer
5. Are residing in one of 10 eligible zip codes;
6. Are English-speaking;
7. Are able to view the study videos;
8. Are able to participate in a video-conference interview using a HIPAA-compliant platform or able to participate in an interview over the phone.

Pilot trial participants will be eligible if they:

1. Are ages 50 - 80 years;
2. Are documented history of at least 20 cigarette pack-years, and who have quit within the past 15 years or are currently smoking;
3. Have no documented history of lung cancer screening or lung cancer;
4. Did not participate in patient interviews;
5. Had a primary care visit at Penn Medicine within the last two years (2020-2022);
6. Are residing in one of 10 eligible zip codes;
7. Are English-speaking;
8. Are able to view the study videos and complete an online survey.

Key Exclusion Criteria:

Patient interview participants are excluded if:

a. They are not eligible for lung cancer screening.

Pilot trial participants are excluded if they:

1. Do not meet inclusion criteria;
2. Participated in patient interviews.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; This arm includes patients who view the integrated health video that provides information about both smoking and environmental risk.	Behavioral: Intervention video; This intervention is an integrated health video provides individual (smoking) and environmental risk communication on intention to obtain lung cancer screening.
Experimental: Control Video Arm; This arm includes patients who view the integrated health video that provides information ONLY about smoking risk.	Behavioral: Control video; This intervention is an integrated health video provides individual (smoking) risk communication on intention to obtain lung cancer screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients who intend or do obtain lung cancer screening within the next 3 months.	This outcome will be measured using a post-test survey given to patients immediately after viewing a health education video assessing the patient's intention to obtain a lung cancer screening within the next 3 months.	Assessed immediately after viewing the health education video.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of lung cancer screening	We will utilize chart review and medical record data to assess whether patients scheduled or received a lung cancer screening within 6 months of enrollment in the study.	6 months of study enrollment

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Katharine Rendle, PhD,MSW,MPH, University of Pennsylvania; Principal Investigator: Andy Tan, PhD,MPH,MBA, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Screening
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 849953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No