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

NCT05523583 | Completed

• 1 other identifier: 69HCL22_0090
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Lung or Head and Neck Cancer

Keywords

lung cancer; head and neck cancer; tabacco; alcohol

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

questionnaire OTHER

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.

Also known as: Tabacco and alcohol questionnaires

Patients newly diagnosed with lung cancer or head & neck cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• International Agency for Research on Cancer: collaborator

Study Sites (4)

Hôpital Louis Pradel, Pneumologie

Bron, 69317, France

Location

Hôpital de la Croix-Rousse, Oto-Rhino-Laryngologie et Chirurgie Cervico-Faciale

Lyon, 69004, France

Location

Hôpital de la Croix-Rousse, Pneumologie

Lyon, 69004, France

Location

Hôpital Lyon Sud, Pneumologie

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms

Interventions

Surveys and Questionnaires; Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Alcohols; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 31, 2022
• Study Start: October 27, 2022
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

FR (4)