Phone Enabled Implementation of Cessation Support (PHOENICS)

Smoking Cessation Clinical Trial

Official title:

Phone Enabled Implementation of Cessation Support (PHOENICS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05628389
• Other study ID #: IRB202202537 -N
• Secondary ID: R01CA262319
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: August 31, 2027

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The tobacco use burden in Lebanon is exceptionally high: 35% of adults are current cigarette smokers and 39% are current waterpipe smokers. Although the World Health Organization endorses evidence-based interventions for population-level tobacco dependence treatment, recommended treatments are not integrated as a routine part of primary care in Lebanon, as is the case in other low-resource settings. The objective of this proposal is to evaluate the comparative effectiveness of promising multi-component interventions for implementing evidence-based cessation treatment in Lebanon's national system of primary health care centers.

Description:

The research team will conduct a group-randomized trial comparing three arms: 1) Ask about tobacco use, advise to quit, assist with brief counseling (AAA) as standard care; 2) Ask, advise, connect to phone-based counseling (AAC); and 3) AAC+ Nicotine Replacement Therapy (NRT). Our central hypothesis is that connecting patients to phone-based counseling with cessation medication is the most effective alternative. The hybrid design is informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework which emphasizes key steps and multilevel factors to optimize implementation success. The following specific aims will be pursued: 1) adapt and tailor an existing smoking cessation program to deliver phone-based counseling to smokers in Lebanon; 2) test the effectiveness and cost-effectiveness of a referral-based program that delivers smoking cessation services to primary care patients; and 3) identify the multilevel determinants of implementation and sustainability using mixed methods.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: August 31, 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18+
• A current daily cigarette smoker and/or a regular waterpipe smoker (smokes at least 1-2 times/week).
• Not pregnant
• Reachable by phone
• Interested in quitting
• Lives in Greater Beirut Area

Exclusion Criteria:

• Patients who smoke other tobacco products including vape, IQOS and others exclusively.
• Any patient below 18 years old.
• Cigarette smokers who do not smoke on daily basis.
• Waterpipe smokers who smoke less than once/weekly

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Educational materials
Patient educational materials to address insufficient knowledge about harms of tobacco use and cessation.
• Phone counseling
Cessation counseling to address insufficient patient self-efficacy and motivation.

Drug:
• Nicotine Replacement Therapy
Nicotine patches to address nicotine withdrawal symptoms in patients.

Behavioral:
• Provider training
Provider training to address insufficient knowledge and self-efficacy to deliver AAA/AAC to patients.
• Electronic reminders
Electronic reminders to address the lack of integration of AAA/AAC into practice.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Hamra	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Cancer Institute (NCI)

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported abstinence	Continuous abstinence, quit attempts, smoking reduction	1, 3, 6 months
Primary	7-day smoking abstinence	Carbon monoxide confirmed-abstinence from smoking in the last 7 days days prior to assessment	6 Months