Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer (SMALLHAN)

The overarching goal of the proposed study is to provide information which can lead to effective implementation of cessation support in the care of smokers diagnosed with lung or head & neck cancer.

To achieve these aims, the study propose to conduct a longitudinal cohort study of patients diagnosed with lung or head & neck cancer at the Hospices Civils de Lyon (SMALLHAN). Briefly, adult patients newly diagnosed with lung or head & neck cancer will be recruited at the time of diagnosis (announcement of diagnosis and consultation).

Study Overview

• Status: Completed
• Conditions: Lung or Head and Neck Cancer
• Intervention / Treatment: Other: questionnaire

• Study Type: Observational
• Enrollment (Actual): 165

Contacts and Locations

Study Locations

• France
  • Bron, France, 69317
    • Hôpital Louis Pradel, Pneumologie
  • Lyon, France, 69004
    • Hôpital de la Croix-Rousse, Oto-Rhino-Laryngologie et Chirurgie Cervico-Faciale
  • Lyon, France, 69004
    • Hôpital de la Croix-Rousse, Pneumologie
  • Pierre-Bénite, France, 69310
    • Hôpital Lyon Sud, Pneumologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

.): Patients treated in HCL, newly diagnosed with lung cancer or head & neck cancer (International Classification of Diseases 10: C76, C34) who undergo front-line treatment and who had at least one episode of smoking within the past 30 days before diagnosis

Description

Inclusion Criteria:

• Patients newly diagnosed with lung cancer or head & neck cancer (International Classification of Diseases 10: C76, C34)
• Patients who undergo front-line treatment
• Age 18 years or older
• Benefiting from a Social Security scheme
• Written information about the study provided to the patient before any procedure specific to the study
• Patients who had at least one episode of smoking within the past 30 days before diagnosis

Exclusion Criteria:

• History of another lung or head & neck cancer < 5 years (Note: The presence of a second tumour location, discovered at the same time as the lung or head and neck cancer, does not constitute a non-inclusion criterion)
• History of another cancer (except for curatively treated cervical cancer in situ and non-melanoma skin cancer) < 3 years
• Mesothelioma, thymic malignancies, and cancer of the upper oesophagus
• Inability to complete the study for psychosocial reasons (inability to schedule interview (homeless), no access to phone, psychological disorder leading to inability to answer phone interview, do not speak French and no easy access to translator from surroundings)
• Patient under guardianship
• Patient refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients newly diagnosed with lung cancer or head & neck cancer; Patients newly diagnosed with lung cancer or head & neck cancer (International Classification of Diseases 10: C76, C34) who undergo front-line treatment and who had at least one episode of smoking within the past 30 days before diagnosis

Other: questionnaire; A trained interviewer (Clinical Research Associate : CRA) will administer a questionnaire soon after the diagnosis on the phone (within 15 calendar days after diagnosis). The participants are followed up during the first year following the diagnosis through 3 follow-up assessments (at 3, 6, and 12 months after the baseline assessment) and hospital record reviews. At each follow-up, a brief questionnaire will be administered by an interviewer (CRA) via telephone.; Other Names: Tabacco and alcohol questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of socio-professional determinants obtained by questionnaire	specific questionnaires querying demographics, socio-professional status, cessation or reduction attempts, and motivation and barriers to cessation, psychiatric conditions including level of addiction and depression.	Baseline
Description of accessibility-related determinants obtained by questionnaire	specific questionnaire querying travel time, distance, means of transportation used to access the hospital or cessation services	Baseline
Change of odds ratios and corresponding 95% confidence intervals for non-use of cessation services evaluated by questionnaire(0=non-use of service, 1=use of service)		Baseline and 3, 6 and 12 months
Change of odds ratios and corresponding 95% confidence intervals for continuation or relapse of tobacco use or dual use of tobacco and alcohol evaluated by questionnaire (0=abstinent, 1=continuation or relapse)		Baseline and 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Collaborators: International Agency for Research on Cancer

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Actual): September 18, 2025
• Study Completion (Actual): September 18, 2025

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: lung cancer; alcohol; head and neck cancer; tabacco
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Head and Neck Neoplasms; Health Care Quality, Access, and Evaluation; Organic Chemicals; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Alcohols; Ethanol; Surveys and Questionnaires
• Other Study ID Numbers: 69HCL22_0090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision on sharing individual participant data has not yet been made. Data sharing will depend on sponsor policy, ethical approval, and compliance with applicable regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No