Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free

Lung Cancer Clinical Trial

Official title:

Motivating Smoking Cessation and Relapse Prevention Among Lung Cancer Patients: Helping and Empowering pAtients for Living a Life Smoke-free (Project HEALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05362318
• Other study ID #: MCC-21108
• Status: Completed
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: January 28, 2023

Study information

• Verified date: June 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to pilot test a multi-modal smoking cessation and relapse prevention intervention with the lung cancer patient population and to obtain preliminary data on its feasibility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 28, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Smoked at least 100 cigarettes in lifetime

• Current smoking (defined as self-report of any smoking, even a puff, in the past 30 days)

• Diagnosis of lung cancer

• Able to read and write English

• Not currently enrolled in a smoking cessation program

• Has a working telephone

• Has a valid home address

Exclusion Criteria:

• Current use of tobacco cessation medications

• Another household member enrolled in this study

• Contraindication of nicotine patch, unless under the supervision of a physician as advised by project staff

• Moffitt clinical trial participant at time of enrollment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Smoking
• Tobacco Use

Intervention

Drug:
• Nicotine patch and lozenges
Participants will receive nicotine patch and lozenges. The regimen will be based on the participant's self-reported smoking rate. At the time of enrollment, a research staff member will determine the proper dose. Participants who smoke >10 cigarettes/day will receive 8 weeks of 21 mg. patches, 2 weeks of 14 mg. patches, 2 weeks of 7 mg. patches, and 12 weeks of 2 mg. lozenges. Those who smoke <10 cigarettes/day will receive 8 weeks of 14 mg. patches, 4 weeks of 7 mg patches, and 12 weeks of 2 mg. lozenges

Behavioral:
• Telephone counseling sessions
Participants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period.
• Access to a web-based video
Participants will be given web-based access to the relapse prevention video "Surviving Smokefree".
• Florida Tobacco Quitline
Participants will receive an offer of enrollment to the Florida Tobacco Quitline which enables participant to speak with a Quit Coach who will assess nicotine addiction and help create a quit plan.

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who meet inclusion criteria	Percentage of participants who meet inclusion criteria	Baseline
Primary	Percentage of participants who agree to participate in the study	Percentage of participants who agree to participate in the study	Baseline
Primary	Percentage of participants completing baseline assessment	Percentage of participants completing baseline assessment	Baseline
Primary	Percentage of participants completing the 3 month follow-up assessments	Percentage of participants completing the 3 month follow-up assessments	at 3 months
Primary	Percentage of participants completing the 6 month follow-up assessments	Percentage of participants completing the 6 month follow-up assessments	at 6 months
Primary	Treatment satisfaction - Acceptability	Mean scores of the Client Satisfaction Questionnaire (SCQ-8) will be used for this measure. The CSQ-8 comprises 8 items for the assessment of treatment satisfaction using a scale from 8 to 32, with higher scores indicating greater satisfaction.	at 6 months
Primary	Completion rate of MAPS calls for UC+MAPS+RP participants - Demand	Percentage of MAPS calls completed for UC+MAPS+RP participants	at 6 months
Primary	Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand	Percentage of UC+MAPS+RP participants who viewed the web based video	at 3 months
Primary	Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand	Percentage of UC+MAPS+RP participants who viewed the web based video	at 6 months