Alberta Lung Cancer Screening Program

NCT02431962 | Unknown

• 1 other identifier: 10007170
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

Lung cancer is the leading cause of cancer death in North America and in the world. The vast majority of lung cancers are associated with cigarette smoking. Unfortunately, the majority of lung cancers are detected at an advanced stage when they have a very poor prognosis. A substantial amount of data has been reported on low-dose computed tomography (LDCT) screening. Yet endorsement of lung cancer screening has not been universal because of outstanding concerns which need to be addressed. Our study will aim to screen at risk Albertans for lung cancer with LDCT scan at baseline, year 1 and year 2 while attempting to fill some knowledge gaps on this topic.

Conditions

Lung Neoplasms; Respiratory Tract Neoplasms

Keywords

Lung Cancer; Screening; Computed Tomography

Outcome Measures

Primary Outcomes (2)

• Comparison of screening enrollment criteria (Risk prediction model (RPM) vs. NLST criteria)

  The proportion of individuals selected by RPM or NLST will be calculated as the number of subjects qualifying and consenting to the screening intervention / total number of subjects enrolled with either criteria. Superiority of the risk prediction model over NLST criteria will be considered established if it identifies at least as many cases of lung cancer as the NLST while sampling fewer individuals.

  5 years

• Randomized trial of smoking cessation intervention in screened individuals (smoking status [smoking rates assessed via questionnaire and abstinence confirmed by saliva nicotine or exhaled carbon minoxide])

  The primary study endpoint will be an assessment of smoking status at 12 months following randomization. Smoking rates will be assessed via phone questionnaire and abstinence confirmed by saliva nicotine test or exhaled carbon monoxide in subjects using nicotine replacement therapies (to avoid false positive nicotine test).

  3 years

Secondary Outcomes (2)

• Evaluation of nodule risk calculator

  3 years

• Health Economics Analysis (healthcare payer and all direct health-care related cost)

  4 years

Study Arms (3)

Screening arm

EXPERIMENTAL

Annual low dose screening chest CT scan x 3.

Procedure: Computed Tomography

Smoking cessation counseling

EXPERIMENTAL

Active smokers randomized to this arm will be contacted by a trained smoking cessation counselor and offered cessation support and advice.

Behavioral: Active smokers - Smoking cessation arm

Smoking cessation control

ACTIVE COMPARATOR

Active smokers randomized to this arm will receive general information on available smoking cessation resources.

Behavioral: Active smokers - Control arm

Interventions

Computed Tomography PROCEDURE

Low dose chest CT screening annually x 3

Screening arm

Active smokers - Smoking cessation arm BEHAVIORAL

Phone based smoking cessation counseling

Smoking cessation counseling

Active smokers - Control arm BEHAVIORAL

Subjects will be provided with general information on available smoking cessation resources

Smoking cessation control

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects between the ages of 55 and 80 with a risk prediction model (RPM) ≥1.5% (≥ 1.5% risk of lung cancer over 6 years) OR NLST criteria (age 55-74; ≥ 30 pack-year smoking history; ongoing smoking or quit within 15 years).
• Ability to provide informed consent and participate in study procedures.

You may not qualify if:

• Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), severe lung disease or lung disease requiring supplemental oxygen that in the opinion of the physician unlikely to benefit from screening due to shortened life-expectancy from the co-morbidities or inability to tolerate diagnosis and treatment of a screen detected abnormality. European Cooperative Oncology Group performance status \> 2.
• History of lung cancer.
• Have had other cancer or treatment for cancer within the past 5 years with the exception of the following cancers: non-melanomatous skin cancer, localized prostate cancer, carcinoma in situ (CIS) of the cervix, or superficial bladder cancer. Treatment of the exceptions must have ended \> 6 months before registration into this study.
• Pregnancy.
• Hemoptysis in past 12 months.
• Unexplained weight loss \>15 pounds / 7kg in past 12 months.
• Unwilling to have a LDCT of chest.
• Unwilling to sign a consent.
• Have had a CT scan of the chest in the last 2 years.

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Cancer Foundation: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N4N1, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (2)

• Tremblay A, Taghizadeh N, MacEachern P, Burrowes P, Graham AJ, Lam SC, Yang H, Koetzler R, Tammemagi MC, Taylor K, Bedard ELR. Two-Year Follow-Up of a Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program. JTO Clin Res Rep. 2020 Sep 15;2(2):100097. doi: 10.1016/j.jtocrr.2020.100097. eCollection 2021 Feb.

  PMID: 34589978 DERIVED

• Tremblay A, Taghizadeh N, Huang J, Kasowski D, MacEachern P, Burrowes P, Graham AJ, Dickinson JA, Lam SC, Yang H, Koetzler R, Tammemagi M, Taylor K, Bedard ELR. A Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program. J Thorac Oncol. 2019 Sep;14(9):1528-1537. doi: 10.1016/j.jtho.2019.04.024. Epub 2019 May 8.

  PMID: 31077790 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Respiratory Tract Neoplasms

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alain Tremblay, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

CA (2)