Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Ad… (NCT02540174) | Clinical Trial Compass
CompletedNot Applicable
Alcohol and Tobacco Consumption in Patients With Head and Neck or Lung Cancer : Interest of an Addiction Treatment
France133 participantsStarted 2015-05-27
Plain-language summary
This is a multicenter, interventional, randomized study among patients with a first lung or head \& neck cancer who are still active smokers ± alcohol misusers.The study will aim to compare the systematic implementation of an addiction treatment program initiated at hospital and integrated to the initial cancer treatment program (Arm A), versus the as-usual procedure, which consists in recommendations to follow an addiction treatment program (Arm B)
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a first upper aerodigestive tract cancer or a lung cancer
* Initial cancer treatment
* Aged ≥ 18 and ≤65 years
* Living within a radius of 20 km from the CHRU de Lille/Oscar Lambret Center
* Patient with tobacco addiction: regular smoker = at least 7 cigarettes /week or 1 cigarette/day or short-term ex-smoker = regular smoker who has stopped smoking for less than 1 year from the inclusion date
* Performance status (ECOG/WHO) ≤ 2
* Registered with a social security system
* Informed and signed consent collected before initiation of any study procedures
Exclusion Criteria:
* Previous lung cancer or upper aerodigestive tract cancer
* Previous other cancer \< 5 years, evoluting or treated at the inclusion (except uterine cervical carcinoma, basal cell or squamous cell skin carcinoma )
* Mesothelioma and esophageal cancer
* Occasional smoker (less than 7 cigarettes/week or less than 1 cigarette/day)
* Long-term ex-smokers who have stopped smoking for more than 1 year from the inclusion date
* Impossibility to comply with the study procedures due to geographic, social or mental reasons
* Patient under guardianship or tutorship
* Pregnant or breastfeeding women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in the rates of tobacco abstinent patients at 12 months between arms A and B