Lung Cancer Screening Education for Head and Neck Cancer Survivors

(GUIAR Trial)

Overseen By Coral Olazagasti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Lung cancer, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Lung Cancer Screening Education for Head and Neck Cancer Survivors?

Research shows that low-dose computed tomography (LDCT) is effective for lung cancer screening in heavy smokers, improving patient-centered outcomes like quality of life and reducing anxiety. Effective communication and education about screening results, as seen in other studies, can enhance understanding and preparedness, potentially benefiting head and neck cancer survivors as well. ^{1 2 3 4 5}

Is Lung Cancer Screening Education using Low-Dose Computed Tomography (LDCT) generally safe for humans?

Low-dose computed tomography (LDCT) screening for lung cancer is generally considered safe, with rare harms reported. It is recommended by multiple organizations for high-risk individuals, and careful planning is needed to ensure the benefits outweigh any potential risks. ^{3 6 7 8 9}

How does lung cancer screening education for head and neck cancer survivors differ from other treatments?

This treatment is unique because it focuses on educating head and neck cancer survivors about lung cancer screening using low-dose computed tomography (LDCT), which is a non-invasive imaging technique that can detect lung cancer early in high-risk individuals. Unlike traditional treatments that directly target cancer, this approach emphasizes prevention and early detection through education and shared decision-making. ^{10 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to assess the awareness of eligibility of lung cancer screening in Hispanic/LatinX Head and Neck Cancer (HNC) survivors using a survey questionnaire; and to understand the barriers to screening using qualitative interviews.

Research Team

Coral Olazagasti

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for Hispanic/LatinX adults over 18 who are head and neck cancer survivors, treated at least 5 years ago without recurrence. They must meet lung cancer screening criteria: either a history of heavy smoking or fitting the age/smoking profile per USPSTF21/NCCN guidelines. Pregnant/nursing individuals, those with recent lung imaging, active cancers, or less than a 20 pack-year smoking history cannot join.

Inclusion Criteria

I survived head and neck cancer, treated over 5 years ago with no recurrence.

You must consider yourself to be Hispanic/LatinX.

You need to be able to understand and sign a form that explains the study.

Exclusion Criteria

I have had head and neck cancer that spread to distant parts of my body.

I have not had head or neck treatment in the last 5 years.

I have smoked less than 20 pack-years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Survey

Participants receive intensive lung cancer screening and tobacco cessation education and complete survey questionnaires to assess awareness and perception of lung cancer screening recommendations

Up to 2 years

Follow-up

Participants are monitored for changes in awareness and perception of lung cancer screening recommendations and undergo early detection lung cancer screening

Up to 2 years

Treatment Details

Interventions

• Lung Cancer Screening Education
• Semi-Structured Interview
• Standard of Care Lung Cancer Screening Program

Trial Overview The study aims to evaluate awareness about lung cancer screening in Hispanic/LatinX head and neck cancer survivors through surveys and interviews. It will also explore barriers to screening participation and provide education on the importance of regular screenings.

Participant Groups

Group I: Standard of Care Control Group Experimental Treatment 1 Intervention

Participants in this group will receive the standard of care treatment for up to two years.

Group II: Lung Cancer Screening Education Group Experimental Treatment 3 Interventions

Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

LUNGevity Foundation

Collaborator

Trials

8

Recruited

1,600+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Lung cancer screening using low-dose computed tomography (LDCT) can cause short-term psychological discomfort, particularly due to false-positive results, but does not significantly impact overall distress or health-related quality of life in the long term.

Negative screening results tend to decrease distress levels, while false positives initially increase distress but return to baseline levels, highlighting the need for effective communication strategies to manage patient anxiety during the screening process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered outcomes among lung cancer screening recipients with computed tomography: a systematic review. Slatore, CG., Sullivan, DR., Pappas, M., et al.[2022]

A study involving 190 patients revealed that while most felt they understood their lung cancer screening results, only 55% actually understood what a lung nodule is, highlighting significant gaps in patient knowledge.

The development of a commonly asked questions (CAQ) information sheet, refined with input from both patients and clinicians, was found to be helpful in improving understanding of lung nodules and incidental findings, suggesting it could enhance communication between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Clinician Recommendations to Improve Communication and Understanding of Lung Cancer Screening Results. Crothers, K., Shahrir, S., Kross, EK., et al.[2023]

In a study involving 2,014 participants in a lung cancer screening program, 70.1% remembered receiving a preparatory information booklet about potential LDCT results, with 72.0% finding it quite or very useful.

The booklet helped improve satisfaction with the communication of results, indicating that providing clear written information is beneficial for participants in large-scale lung cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SUMMIT Study: Utilising a written 'Next Steps' information booklet to prepare participants for potential lung cancer screening results and follow-up. Bhamani, A., Horst, C., Bojang, F., et al.[2023]

A video-based decision aid for lung cancer screening significantly increased patients' knowledge about screening, with correct answers rising from 25.5% to 74.8% after viewing the aid, indicating its effectiveness in educating smokers.

The majority of patients (78.8%) expressed greater interest in lung cancer screening after watching the video, highlighting its potential to enhance informed decision-making among heavy smokers aged 45 to 75.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a patient decision aid about lung cancer screening with low-dose computed tomography. Volk, RJ., Linder, SK., Leal, VB., et al.[2021]

Lung cancer screening using low-dose CT (LDCT) has proven effective in clinical trials, including the National Lung Screening Trial, highlighting its importance in early detection.

The Lung CT Screening Reporting and Data System (Lung-RADS) is recommended for all LDCT exams to improve communication of results and reduce false-positive rates, ensuring better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Lung Cancer: Lexicon for Communicating With Health Care Providers. Carter, BW., Lichtenberger, JP., Wu, CC., et al.[2018]

In a study of 121 patients who underwent low-dose computed tomography (LDCT) screening for lung cancer, the overall adherence rate to follow-up scans was only 59.1%, indicating a need for improved compliance with screening guidelines.

Patients with more concerning findings (Lung-RADS score 2) were 2.43 times more likely to adhere to follow-up scans compared to those with less concerning findings (Lung-RADS score 1), while African American patients showed lower odds of adherence, highlighting potential socioeconomic disparities in lung cancer screening compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. Mortman, KD., Devlin, J., Giang, B., et al.[2023]

In a study of 272 patients screened for lung cancer using low dose computed tomography (LDCT), the lung cancer detection rate was 2.2%, which aligns with findings from the National Lung Screening Trial, indicating the efficacy of LDCT in identifying lung cancer.

The implementation of LDCT screening highlighted the importance of thorough pre-screening evaluations and careful scanning protocols to ensure patient safety, with a mean radiation dose of 3.12 mGy achieved through techniques like tube current modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose Lung Cancer Screening at an Academic Medical Center: Initial Experience and Dose Reduction Strategies. Ahmed, A., Verma, N., Barreto, I., et al.[2019]

Annual low-radiation-dose computed tomography (LDCT) screening can significantly reduce lung cancer mortality in high-risk individuals, but its implementation requires careful planning to maximize benefits and minimize harms.

The American Thoracic Society and American College of Chest Physicians provide a framework for developing LDCT screening programs, outlining essential strategies for planning, implementation, and maintenance to ensure these programs are safe, effective, and sustainable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. Wiener, RS., Gould, MK., Arenberg, DA., et al.[2022]

In a study of 995 patients undergoing lung cancer screening with low-dose computed tomography (LDCT), 2.9% were diagnosed with lung cancer, indicating that screening can lead to early detection in a predominantly African American population.

The screening had a false-positive rate of 9.4%, with very few complications (0.7% from false-positive procedures), highlighting that while harms are rare, they need to be communicated effectively to patients, especially in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening in a Safety-Net Hospital: Rare Harms Inform Decision Making. Lutzow, LK., Magarinos, J., Dass, C., et al.[2022]

Clinicians acknowledge that low-dose computed tomography (LDCT) lung cancer screening (LCS) can be beneficial for some survivors of head and neck cancer (HNC) with a history of smoking, but they face significant challenges in implementing shared decision-making (SDM) practices.

Barriers to effective LCS implementation include time constraints, unclear guidelines, lack of tailored decision aids, and competing patient priorities, indicating a need for further research and refinement of current screening guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes of Clinicians about Screening Head and Neck Cancer Survivors for Lung Cancer Using Low-Dose Computed Tomography. Dukes, K., Seaman, AT., Hoffman, RM., et al.[2022]

In a community-based lung cancer screening program in a Histoplasma endemic region, 4500 low-dose computed tomography (LDCT) screens were performed, with a positive screening rate of 13.3%, which is comparable to the National Lung Screening Trial (NLST) results.

The program successfully diagnosed 70 lung cancers from positive screens, indicating effective detection, while maintaining a false positive rate of 12%, demonstrating the program's efficacy in a high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of community-based lung cancer screening program in a Histoplasma endemic region. Bhandari, S., Tripathi, P., Pham, D., et al.[2020]

Training tobacco cessation counselors to provide information about lung cancer screening (LCS) during group counseling is feasible and well-received, with 92% of participants feeling the information was adequate.

Participants showed a high level of understanding regarding LCS, with a median comprehension score of 5 out of 5, indicating that this approach could effectively inform eligible smokers about the benefits and logistics of screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating lung cancer screening education into tobacco cessation group counseling. Raz, DJ., Ismail, MH., Sun, V., et al.[2020]

Low-dose chest computed tomography (LDCT) screening is feasible for lung cancer detection in long-term colorectal cancer survivors, with a significant number of positive findings among participants.

Among the 176 ever-smoking colorectal cancer survivors screened, those classified as at increased risk (RG2) had the highest rate of second malignant neoplasms (30.6%), indicating a need for targeted screening strategies in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Lung Cancer Using Low-dose Chest Computed Tomography in Korean Long-term Colorectal Cancer Survivors. Park, JS., Kang, B., Park, Y., et al.[2022]

Only 18.9% of surveyed smokers had undergone lung cancer screening (LCS) with low-dose computed tomography (LDCT), and none of those who hadn't undergone screening were aware of it, indicating a significant gap in knowledge and utilization.

Common barriers to LCS among smokers included being a current smoker, fear of test results, lack of knowledge about the screening process, and concerns about costs, suggesting that tobacco cessation counseling could be an effective opportunity to educate patients about the benefits of LCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions and Utilization of Lung Cancer Screening Among Smokers Enrolled in a Tobacco Cessation Program. Raz, DJ., Wu, G., Nelson, RA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient-centered outcomes among lung cancer screening recipients with computed tomography: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Patient and Clinician Recommendations to Improve Communication and Understanding of Lung Cancer Screening Results. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

The SUMMIT Study: Utilising a written 'Next Steps' information booklet to prepare participants for potential lung cancer screening results and follow-up. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a patient decision aid about lung cancer screening with low-dose computed tomography. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Screening for Lung Cancer: Lexicon for Communicating With Health Care Providers. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Low-dose Lung Cancer Screening at an Academic Medical Center: Initial Experience and Dose Reduction Strategies. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening in a Safety-Net Hospital: Rare Harms Inform Decision Making. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Attitudes of Clinicians about Screening Head and Neck Cancer Survivors for Lung Cancer Using Low-Dose Computed Tomography. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

Performance of community-based lung cancer screening program in a Histoplasma endemic region. [2020]

12. Greece pubmed.ncbi.nlm.nih.gov

Incorporating lung cancer screening education into tobacco cessation group counseling. [2020]

13. Korea (South) pubmed.ncbi.nlm.nih.gov

Screening for Lung Cancer Using Low-dose Chest Computed Tomography in Korean Long-term Colorectal Cancer Survivors. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Perceptions and Utilization of Lung Cancer Screening Among Smokers Enrolled in a Tobacco Cessation Program. [2022]