NCT03786172

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
3 years until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

4.9 years

First QC Date

December 10, 2015

Last Update Submit

December 20, 2018

Conditions

SmokingHead and Neck Neoplasms

Keywords

Smoking cessationInterventionHead and Neck neoplasmsCognitive therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • continuous abstinence

    12 months

Study Arms (2)

Smoking cessation Intervention

EXPERIMENTAL

Standardised counseling session + motivational gadget + Nicotine replacement therapy (NRT)

Behavioral: Smoking cessation Intervention

Usual care

ACTIVE COMPARATOR

A 10-second brief advice to quit smoking

Behavioral: Usual care

Interventions

Smoking cessation InterventionBEHAVIORAL

* 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

Smoking cessation Intervention
Usual careBEHAVIORAL

A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Head and Neck cancer
  • Patients hospitalised from biopsy or surgery
  • Current smokers = smokers in the past 3 months
  • Reachable by phone

You may not qualify if:

  • Nonsmokers in the past 3 months
  • Current drug dependance
  • Pregnant women
  • Psychiatric conditions
  • Patients under current smoking cessation intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saint-Joseph university

Beirut, 1104 2020, Lebanon

NOT YET RECRUITING

Hôtel-Dieu De France University Hospital

Beirut, 961, Lebanon

RECRUITING

Related 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. No abstract available.

    PMID: 18807274BACKGROUND

  • 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.

    PMID: 23715685BACKGROUND

  • 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.

    PMID: 17119047BACKGROUND

  • 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.

    PMID: 16097900BACKGROUND

  • 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.

    PMID: 12525530BACKGROUND

  • 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.

    PMID: 17636688BACKGROUND

  • 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.

    PMID: 15586136BACKGROUND

  • 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.

    PMID: 21503842BACKGROUND

  • 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.

    PMID: 15133775BACKGROUND

  • 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.

    PMID: 15598756BACKGROUND

  • 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.

    PMID: 18302647BACKGROUND

  • 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.

    PMID: 8318879BACKGROUND

MeSH Terms

Conditions

SmokingHead and Neck NeoplasmsSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsHealth Behavior

Study Officials

  • Amine Haddad, MD ENT

    Hotel Dieu de France Hospital

    STUDY DIRECTOR

Central Study Contacts

Diane Helou, ENT resident

CONTACT

96171112426diane_helou@hotmail.com

Nayla Matar, MD ENT

CONTACT

9613277725naylamatar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2015

First Posted

December 24, 2018

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 24, 2018

Record last verified: 2018-12

Locations

LE(2)