Project PLUS Lung Cancer Screening Promotion

Sponsor
Abramson Cancer Center at Penn Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05937399
Collaborator
(none)
34
1
2
12.9
2.6

Study Details

Study Description

Brief Summary

Project PLUS 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention video
  • Behavioral: Control video
N/A

Detailed Description

Project PLUS 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 Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Project PLUS- Promoting Lung Cancer Screening Among Screening-Eligible Individuals in Environmentally Burdened Communities Through Enhanced Risk Communication
Actual Study Start Date :
Dec 2, 2022
Actual Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The number of patients who intend or do obtain lung cancer screening within the next 3 months. [Within 3 months of the patient viewing the health education video.]

    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. The post-test surveys include the UNC Perceived Message Effectiveness Brief Scale (adapted for lung cancer screening) (Baig et al., 2019); and Perceived Effectiveness of Cessation Advertisements (Davis et al., 2012). We will also utilize chart review to assess whether patients scheduled or received a lung cancer screening within 3 months of enrollment in the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov Identifier:
NCT05937399
Other Study ID Numbers:
  • 849953
First Posted:
Jul 10, 2023
Last Update Posted:
Jul 10, 2023
Last Verified:
Jul 1, 2023
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
Keywords provided by Abramson Cancer Center at Penn Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 10, 2023