Feasibility of a Virtual Smoking Cessation Program

NCT ID: NCT05594199

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-09-11

Brief Summary

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The goal of this pilot study of a clinical trial is to learn about the acceptability and feasibility of a virtual smoking cessation program in both the perioperative and fracture clinic settings. The main questions this study aims to answer are:

* The number of people that participate in the virtual smoking cessation program
* The acceptability of the number, length, content, and delivery of the email messages provided by the program.

Participants will be asked to subscribe to our virtual intervention which will include:

* A smoking cessation e-learning module component to provide education on the risks of smoking in the surgical or fracture clinic setting, and
* An emailing program component that will provide tailored email messages over a 30-45 day period depending on a patient's Fagerstrom test for nicotine dependence score and motivation to quit smoking.

Researchers will also compare the virtual smoking cessation program to standard care to see if there are any differences shown between both groups in the Fagerstrom test for nicotine dependence scores, number of cigarettes smoked, number of quit attempts, complication rates, and re-admission rates at the 7 day and 30 day time points.

Detailed Description

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Smoking is the most preventable cause of disease and premature death in Canada. In this pilot study our aim is to determine whether a virtual perioperative program, using automated emails, for smoking cessation is feasible and acceptable for increasing abstinence from smoking, compared to the usual care in patients undergoing surgery or with an acute traumatic fracture. Patients that present to the preoperative clinic or fracture clinic will be recruited for this trial. This feasibility study will be followed by the proposed randomized control trial to identify whether our planned study procedures are acceptable to surgical patients.

Both components of the virtual smoking cessation program (Smoking cessation e-learning modules and Virtual Program Evaluation) will be more personalized to the patient as the patient's nicotine dependence will determine the tailored information that will be provided in the e-learning module and the email messages. Study procedures and components of the virtual smoking cessation program will be modified for clinical use and future research based on the feedback from this pilot study.

Conditions

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Smoking Smoking Cessation Smoking Reduction Perioperative/Postoperative Complications Fractures, Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Arm: Virtual Group

The intervention will involve participating in the study's virtual smoking cessation program. This program consists of 2 components: an e-learning module and a tailored email messaging program based on the participant's motivation to quit smoking and their Fagerstrom test for nicotine dependence score.

Group Type EXPERIMENTAL

Virtual Smoking Cessation Program

Intervention Type BEHAVIORAL

This program consists of an e-learning smoking cessation education module and a tailored email messaging program.

The e-learning module addresses the potential health benefits to quitting smoking regarding surgery or recovering from a fracture. In addition, it provides information on getting support through the process of quitting smoking based on the individual's level of smoking dependence.

Email frequency and content will vary based on the participant's score and level of motivation. Information will include the risks associated with smoking before surgery or how quitting smoking can improve recovery from a fracture injury. Additional information includes the benefits of quitting smoking and developing coping strategies during a quit attempt. Motivational emails and references to free resources for additional smoking cessation support will also be provided.

Control Arm: Standard Care

This arm will receive standard care which may or may not include brief advice to quit smoking from any of the healthcare providers.

Providing smoking cessation intervention is not mandatory in standard care and may not be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Smoking Cessation Program

This program consists of an e-learning smoking cessation education module and a tailored email messaging program.

The e-learning module addresses the potential health benefits to quitting smoking regarding surgery or recovering from a fracture. In addition, it provides information on getting support through the process of quitting smoking based on the individual's level of smoking dependence.

Email frequency and content will vary based on the participant's score and level of motivation. Information will include the risks associated with smoking before surgery or how quitting smoking can improve recovery from a fracture injury. Additional information includes the benefits of quitting smoking and developing coping strategies during a quit attempt. Motivational emails and references to free resources for additional smoking cessation support will also be provided.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18+ years of age
* Daily or non-daily smoker
* Self-reported smokers who have smoked cigarettes within the past 30 days
* Must be a patient at Toronto Western Hospital or Women's College Hospital who is:

* Scheduled for an elective surgical procedure that will occur at least 48 hours after recruitment OR
* Visiting the fracture clinic (UHN) within and including 14 days from the initial date of injury or operation
* Must have a working e-mail address

Exclusion Criteria

* Patients who have already quit smoking for more than 30 days,
* Patients who cannot read and understand English,
* Patients who have any form of cognitive impairment,
* Patients who do not have a telephone (for follow-up).
* Currently on pharmacological therapy for smoking cessation
* Drug or alcohol abuse or dependence within the past year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Jean Wong

Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean Wong, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Women's College Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Graham AL, Carpenter KM, Cha S, Cole S, Jacobs MA, Raskob M, Cole-Lewis H. Systematic review and meta-analysis of Internet interventions for smoking cessation among adults. Subst Abuse Rehabil. 2016 May 18;7:55-69. doi: 10.2147/SAR.S101660. eCollection 2016.

Reference Type BACKGROUND
PMID: 27274333 (View on PubMed)

Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

Reference Type BACKGROUND
PMID: 1932883 (View on PubMed)

Andersen T, Christensen FB, Laursen M, Hoy K, Hansen ES, Bunger C. Smoking as a predictor of negative outcome in lumbar spinal fusion. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2623-8. doi: 10.1097/00007632-200112010-00018.

Reference Type BACKGROUND
PMID: 11725245 (View on PubMed)

Mills E, Eyawo O, Lockhart I, Kelly S, Wu P, Ebbert JO. Smoking cessation reduces postoperative complications: a systematic review and meta-analysis. Am J Med. 2011 Feb;124(2):144-154.e8. doi: 10.1016/j.amjmed.2010.09.013.

Reference Type BACKGROUND
PMID: 21295194 (View on PubMed)

Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications: a systematic review and meta-analysis. Arch Intern Med. 2011 Jun 13;171(11):983-9. doi: 10.1001/archinternmed.2011.97. Epub 2011 Mar 14.

Reference Type BACKGROUND
PMID: 21403009 (View on PubMed)

Other Identifiers

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22-5475

Identifier Type: -

Identifier Source: org_study_id

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