Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients
NCT ID: NCT03786172
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-01-31
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
After an initial assessment of demographic, clinical and smoking characteristics, the patients are randomised (based on a computer randomisation program) in 2 groups:
* Group 1 will receive the usual care in Lebanon, which consists of a brief advice to quit (10 seconds)
* Group 2 will receive a brief (10-15 minutes) standardised smoking cessation counseling session peri-operatively (immediately before or after surgery), by an ENT residents, based on the 5 "A"'s motivational interviewing model:
* Ask (screen for tobacco use)
* Advise (provide a personalised and strong quit message)
* Assess (evaluate the smoker's willingness and readiness to quit)
* Assist (provide cessation counseling, pharmacotherapy, self-help guides)
* Arrange (for followup to prevent relapse, and evaluate cessation progress) A motivational gadget will be distributed to group 2 patients. They will also be offered nicotine replacement therapy (nicotine transdermal patches) for a total of 8 weeks. This will be followed by a telephone boost session after 6 weeks.
The follow-up at 3, 6 and 12 months will be done, for the 2 groups, by a person not implicated in either the randomisation or the intervention (single-blind), in person or, if impossible, by telephone.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Smoking cessation Intervention
Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)
Smoking cessation Intervention
* A 10 to 15 minute standardised counseling session performed peri-operatively by an ENT resident, and based on the 5 "A"s motivational interviewing model (Ask, Advise, Assess, Assist, Arrange)
* A motivational gadget distributed to the patients
* Nicotine replacement therapy (NRT), consisting of nicotine transdermal patches for 8 weeks, offered to the patients
Usual care
A 10-second brief advice to quit smoking
Usual care
A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Smoking cessation Intervention
* A 10 to 15 minute standardised counseling session performed peri-operatively by an ENT resident, and based on the 5 "A"s motivational interviewing model (Ask, Advise, Assess, Assist, Arrange)
* A motivational gadget distributed to the patients
* Nicotine replacement therapy (NRT), consisting of nicotine transdermal patches for 8 weeks, offered to the patients
Usual care
A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients hospitalised from biopsy or surgery
* Current smokers = smokers in the past 3 months
* Reachable by phone
Exclusion Criteria
* Current drug dependance
* Pregnant women
* Psychiatric conditions
* Patients under current smoking cessation intervention
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hotel Dieu de France Hospital
OTHER
Saint-Joseph University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amine Haddad, MD ENT
Role: STUDY_DIRECTOR
Hotel Dieu de France Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Saint-Joseph university
Beirut, , Lebanon
Hôtel-Dieu De France University Hospital
Beirut, , Lebanon
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Maya Samaha, Librarian
Role: primary
Husein Smayli, MD
Role: primary
Nayla Matar, MD; PHD
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
2008 PHS Guideline Update Panel, Liaisons, and Staff. Treating tobacco use and dependence: 2008 update U.S. Public Health Service Clinical Practice Guideline executive summary. Respir Care. 2008 Sep;53(9):1217-22. No abstract available.
Nayan S, Gupta MK, Strychowsky JE, Sommer DD. Smoking cessation interventions and cessation rates in the oncology population: an updated systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2013 Aug;149(2):200-11. doi: 10.1177/0194599813490886. Epub 2013 May 28.
Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2203-8. doi: 10.1158/1055-9965.EPI-05-0880.
Schnoll RA, Rothman RL, Wielt DB, Lerman C, Pedri H, Wang H, Babb J, Miller SM, Movsas B, Sherman E, Ridge JA, Unger M, Langer C, Goldberg M, Scott W, Cheng J. A randomized pilot study of cognitive-behavioral therapy versus basic health education for smoking cessation among cancer patients. Ann Behav Med. 2005 Aug;30(1):1-11. doi: 10.1207/s15324796abm3001_1.
Schnoll RA, Zhang B, Rue M, Krook JE, Spears WT, Marcus AC, Engstrom PF. Brief physician-initiated quit-smoking strategies for clinical oncology settings: a trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2003 Jan 15;21(2):355-65. doi: 10.1200/JCO.2003.04.122.
Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001837. doi: 10.1002/14651858.CD001837.pub2.
Wakefield M, Olver I, Whitford H, Rosenfeld E. Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. Nurs Res. 2004 Nov-Dec;53(6):396-405. doi: 10.1097/00006199-200411000-00008.
Gosselin MH, Mahoney MC, Cummings KM, Loree TR, Sullivan M, King BA, Warren G, Hyland A. Evaluation of an intervention to enhance the delivery of smoking cessation services to patients with cancer. J Cancer Educ. 2011 Sep;26(3):577-82. doi: 10.1007/s13187-011-0221-3.
Schnoll RA, Rothman RL, Newman H, Lerman C, Miller SM, Movsas B, Sherman E, Ridge JA, Unger M, Langer C, Goldberg M, Scott W, Cheng J. Characteristics of cancer patients entering a smoking cessation program and correlates of quit motivation: implications for the development of tobacco control programs for cancer patients. Psychooncology. 2004 May;13(5):346-58. doi: 10.1002/pon.756.
Gorin SS, Heck JE. Meta-analysis of the efficacy of tobacco counseling by health care providers. Cancer Epidemiol Biomarkers Prev. 2004 Dec;13(12):2012-22.
Sharp L, Johansson H, Fagerstrom K, Rutqvist LE. Smoking cessation among patients with head and neck cancer: cancer as a 'teachable moment'. Eur J Cancer Care (Engl). 2008 Mar;17(2):114-9. doi: 10.1111/j.1365-2354.2007.00815.x.
Gritz ER, Carr CR, Rapkin D, Abemayor E, Chang LJ, Wong WK, Belin TR, Calcaterra T, Robbins KT, Chonkich G, et al. Predictors of long-term smoking cessation in head and neck cancer patients. Cancer Epidemiol Biomarkers Prev. 1993 May-Jun;2(3):261-70.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CEHDF600
Identifier Type: -
Identifier Source: org_study_id