Project PLUS Lung Cancer Screening Promotion

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05937399
• Other study ID #: UPCC 03523
• Secondary ID: 849953
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: December 31, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Intervention video
This intervention is an integrated health video provides individual (smoking) and environmental risk communication on intention to obtain lung cancer screening.
• Control video
This intervention is an integrated health video provides individual (smoking) risk communication on intention to obtain lung cancer screening.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Completion of lung cancer screening	The study team 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