Efficacy of Smoking Cessation Intervention for Head and Neck Cancer Patients

Smoking Clinical Trial

Official title:

Smoking Cessation Intervention for Head and Neck Cancer Patients: A Prospective Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03786172
• Other study ID #: CEHDF600
• Status: Recruiting
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: December 2018
• Source: Saint-Joseph University
• Contact: Diane Helou, ENT resident
• Phone: 96171112426
• Email: diane_helou[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Head and Neck cancer

• Patients hospitalised from biopsy or surgery

• Current smokers = smokers in the past 3 months

• Reachable by phone

Exclusion Criteria:

• Nonsmokers in the past 3 months

• Current drug dependance

• Pregnant women

• Psychiatric conditions

• Patients under current smoking cessation intervention

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Smoking

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Lebanon	Hôtel-Dieu De France University Hospital	Beirut
Lebanon	Saint-Joseph university	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
Saint-Joseph University	Hotel Dieu de France Hospital

Country where clinical trial is conducted

Lebanon, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001837. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD001837. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sharp L, Johansson H, Fagerström 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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence abstinence	The patient is considered abstinent if he reported not smoking for at least 7 days before the interview	12 months
Secondary	continuous abstinence	continuous abstinence from smoking at the time of follow-up, since the quit date	12 months