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

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Use; Lung Cancer
• Intervention / Treatment: Drug: Nicotine patch and lozenges; Behavioral: Florida Tobacco Quitline; Behavioral: Telephone counseling sessions; Behavioral: Access to a web-based video

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33617
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Usual Care; Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges).	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: 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.
Experimental: Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention; Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video.	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: 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.; Behavioral: Telephone counseling sessions; Participants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period.; Behavioral: Access to a web-based video; Participants will be given web-based access to the relapse prevention video "Surviving Smokefree".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants who meet inclusion criteria	Percentage of participants who meet inclusion criteria	Baseline
Percentage of participants who agree to participate in the study	Percentage of participants who agree to participate in the study	Baseline
Percentage of participants completing baseline assessment	Percentage of participants completing baseline assessment	Baseline
Percentage of participants completing the 3 month follow-up assessments	Percentage of participants completing the 3 month follow-up assessments	at 3 months
Percentage of participants completing the 6 month follow-up assessments	Percentage of participants completing the 6 month follow-up assessments	at 6 months
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
Completion rate of MAPS calls for UC+MAPS+RP participants - Demand	Percentage of MAPS calls completed for UC+MAPS+RP participants	at 6 months
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
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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Vani N Simmons, PhD, Moffitt Cancer Center; Principal Investigator: Jennifer I Vidrine, PhD, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): January 28, 2023
• Study Completion (Actual): January 28, 2023

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 4, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: MCC-21108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No