Clinical trial NCT05937399: Project PLUS Lung Cancer Screening Promotion
Official title: Project PLUS- Promoting Lung Cancer Screening Among Screening-Eligible Individuals in Environmentally Burdened Communities Through Enhanced Risk Communication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Screening
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of patients who intend or do obtain lung cancer screening within the next 3 months.
timeFrame: Assessed immediately after viewing the health education video.
Secondary outcomes:
measure: Completion of lung cancer screening
timeFrame: 6 months of study enrollment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katharine Rendle, PhD,MSW,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Andy Tan, PhD,MPH,MBA
role: PRINCIPAL_INVESTIGATOR
References: