SmokingNCT03786172
Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients
A study testing Smoking cessation Intervention in people with Smoking and Head and Neck Neoplasms, run by Saint-Joseph University at 2 sites in Lebanon.
Trial summary
The purpose of this study is to determine whether a brief smoking ENT-resident-based intervention increased smoking cessation in patients with Head and Neck cancer attending a Lebanese university hospital, as compared with usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Head and Neck Neoplasms
- What is being tested?
- Smoking cessation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesLebanon
- Study dates
- Jan 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Head and Neck cancer
- Patients hospitalised from biopsy or surgery
- Current smokers = smokers in the past 3 months
- Reachable by phone
Who cannot join
- Nonsmokers in the past 3 months
- Current drug dependance
- Pregnant women
- Psychiatric conditions
- Patients under current smoking cessation intervention
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites, 2 recruiting
- Not yet recruiting
Saint-Joseph university
Beirut, 1104 2020
Maya Samaha, Librarian, 9611421000 ext. 2211, msamaha@usj.edu.lb
Diane Helou, ENT resident
- Recruiting
Hôtel-Dieu De France University Hospital
Beirut, 961
Husein Smayli, MD, 96170817106, hussein.smayli@hotmail.com
Nayla Matar, MD; PHD, 96103277725
About this study
Official title: Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial
The purpose of this study is to determine whether a brief smoking ENT-resident-based intervention increased smoking cessation in patients with Head and Neck cancer attending a Lebanese university hospital, as compared with usual care.
Read the detailed description
The primary objective of the study is to evaluate the effectiveness of a brief smoking physician-based intervention on smoking-cessation rates in Head and Neck cancer adult patients. The secondary objective is to assess predictors of long-term smoking cessation in such patients.
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
- Smoking, Head and Neck Neoplasms
- Being tested
- Smoking cessation Intervention, Usual care
- Keywords
- Smoking cessation, Intervention, Head and Neck neoplasms, Cognitive therapy
- Medical subject headings
- Smoking, Head and Neck Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation InterventionBehavioural
- 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 careBehavioural
A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation Intervention | Experimental | Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT) Receives: Behavioral: Smoking cessation Intervention |
| Usual care | Active comparator | A 10-second brief advice to quit smoking Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence
The patient is considered abstinent if he reported not smoking for at least 7 days before the interview
Measured: 12 months
Secondary outcomes (1)
continuous abstinence
continuous abstinence from smoking at the time of follow-up, since the quit date
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study startJan 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Collaborators
- Hotel Dieu de France Hospital
- Responsible party
- Sponsor
- Investigators
- Amine Haddad, MD ENT, Study director, Hotel Dieu de France Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786172
- Sponsor's protocol ID
- CEHDF600
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2015
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18807274Nayan 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.
PubMed 23715685Duffy 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.
PubMed 17119047Schnoll 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.
PubMed 16097900Schnoll 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.
PubMed 12525530Rigotti 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.
PubMed 17636688Wakefield 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.
PubMed 15586136Gosselin 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.
PubMed 21503842Schnoll 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.
PubMed 15133775Gorin 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.
PubMed 15598756Sharp 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.
PubMed 18302647Gritz 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.
PubMed 8318879
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03786172
- Acronym / sponsor ID
- CEHDF600
- Conditions
- Smoking, Head and Neck Neoplasms
- Keywords
- Smoking cessation, Intervention, Head and Neck neoplasms, Cognitive therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Collaborators
- Hotel Dieu de France Hospital
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a brief smoking ENT-resident-based intervention increased smoking cessation in patients with Head and Neck cancer attending a Lebanese university hospital, as compared with usual care.
Detailed description
The primary objective of the study is to evaluate the effectiveness of a brief smoking physician-based intervention on smoking-cessation rates in Head and Neck cancer adult patients. The secondary objective is to assess predictors of long-term smoking cessation in such patients.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation Intervention | Experimental | Behavioral: Smoking cessation InterventionStandardised counseling session + motivational gadget + Nicotine replacement therapy (NRT) |
| Usual care | Active comparator | Behavioral: Usual careA 10-second brief advice to quit smoking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Head and Neck cancer
- Patients hospitalised from biopsy or surgery
- Current smokers = smokers in the past 3 months
- Reachable by phone
Key exclusion criteria (5 listed)
- Nonsmokers in the past 3 months
- Current drug dependance
- Pregnant women
- Psychiatric conditions
- Patients under current smoking cessation intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Smoking cessation Intervention |
| Usual careA 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident | Behavioural | Usual care |
Primary outcome
7-day point prevalence abstinence
Time frame: 12 months
The patient is considered abstinent if he reported not smoking for at least 7 days before the interview
1 secondary outcome
continuous abstinence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Background: PubMed 188072742008 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.
- Background: PubMed 23715685Nayan 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.
- Background: PubMed 17119047Duffy 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.
- Background: PubMed 16097900Schnoll 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.
- Background: PubMed 12525530Schnoll 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.
- Background: PubMed 17636688Rigotti 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.
- Background: PubMed 15586136Wakefield 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.
- Background: PubMed 21503842Gosselin 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.
- Background: PubMed 15133775Schnoll 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.
- Background: PubMed 15598756Gorin 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.
- Background: PubMed 18302647Sharp 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.
- Background: PubMed 8318879Gritz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amine Haddad, MD ENT study director
Hotel Dieu de France Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation Intervention in people with Smoking and Head and Neck Neoplasms, run by Saint-Joseph University at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diane Helou, ENT resident (96171112426, diane_helou@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03786172, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.