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Trial Title:
Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer
NCT ID:
NCT05523583
Condition:
Lung or Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Alcohol Drinking
Conditions: Keywords:
lung cancer
head and neck cancer
tabacco
alcohol
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
questionnaire
Description:
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.
Arm group label:
Patients newly diagnosed with lung cancer or head & neck cancer
Other name:
Tabacco and alcohol questionnaires
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).
Criteria for eligibility:
Study pop:
.): 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
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Louis Pradel, Pneumologie
Address:
City:
Bron
Zip:
69317
Country:
France
Status:
Recruiting
Contact:
Last name:
Michaël DURUISSEAUX, MD
Phone:
427857700
Phone ext:
+33
Email:
michael.duruisseaux@chu-lyon.fr
Facility:
Name:
Hôpital de la Croix-Rousse, Oto-Rhino-Laryngologie et Chirurgie Cervico-Faciale
Address:
City:
Lyon
Zip:
69004
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre PHILOUZE, MD
Phone:
426732770
Phone ext:
+33
Email:
pierre.philouze@chu-lyon.fr
Facility:
Name:
Hôpital de la Croix-Rousse, Pneumologie
Address:
City:
Lyon
Zip:
69004
Country:
France
Status:
Recruiting
Contact:
Last name:
Lize KIAKOUAMA, MD
Phone:
472071730
Phone ext:
+33
Email:
lize.kiakouama@chu-lyon.fr
Facility:
Name:
Hôpital Lyon Sud, Pneumologie
Address:
City:
Pierre-Bénite
Zip:
69310
Country:
France
Status:
Recruiting
Contact:
Last name:
Sébastien COURAUD, MD
Phone:
4 78 86 44 01
Phone ext:
+33
Email:
sebastien.couraud@chu-lyon.fr
Start date:
October 27, 2022
Completion date:
October 27, 2025
Lead sponsor:
Agency:
Hospices Civils de Lyon
Agency class:
Other
Collaborator:
Agency:
International Agency for Research on Cancer
Agency class:
Other
Source:
Hospices Civils de Lyon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05523583