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Clinical Trials/NCT05523583
NCT05523583
Completed
Not Applicable

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

Hospices Civils de Lyon4 sites in 1 country165 target enrollmentOctober 27, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung or Head and Neck Cancer
Sponsor
Hospices Civils de Lyon
Enrollment
165
Locations
4
Primary Endpoint
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)
Status
Completed
Last Updated
7 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 27, 2022
End Date
September 18, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Time Frame: Baseline and 3, 6 and 12 months

Description of socio-professional determinants obtained by questionnaire

Time Frame: Baseline

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.

Description of accessibility-related determinants obtained by questionnaire

Time Frame: Baseline

specific questionnaire querying travel time, distance, means of transportation used to access the hospital or cessation services

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)

Time Frame: Baseline and 3, 6 and 12 months

Study Sites (4)

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