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

Primary Purpose

Smoking, Tobacco Use, Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine patch and lozenges
Telephone counseling sessions
Access to a web-based video
Florida Tobacco Quitline
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moffitt Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group 1: Usual Care

Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Percentage of Participants who meet inclusion criteria
Percentage of participants who meet inclusion criteria
Percentage of participants who agree to participate in the study
Percentage of participants who agree to participate in the study
Percentage of participants completing baseline assessment
Percentage of participants completing baseline assessment
Percentage of participants completing the 3 month follow-up assessments
Percentage of participants completing the 3 month follow-up assessments
Percentage of participants completing the 6 month follow-up assessments
Percentage of participants completing the 6 month follow-up assessments
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.
Completion rate of MAPS calls for UC+MAPS+RP participants - Demand
Percentage of MAPS calls completed for UC+MAPS+RP participants
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
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

Secondary Outcome Measures

Full Information

First Posted
April 29, 2022
Last Updated
June 20, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05362318
Brief Title
Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free
Official Title
Motivating Smoking Cessation and Relapse Prevention Among Lung Cancer Patients: Helping and Empowering pAtients for Living a Life Smoke-free (Project HEALS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
January 28, 2023 (Actual)
Study Completion Date
January 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco Use, Lung Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Usual Care
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch and lozenges
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Telephone counseling sessions
Intervention Description
Participants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period.
Intervention Type
Behavioral
Intervention Name(s)
Access to a web-based video
Intervention Description
Participants will be given web-based access to the relapse prevention video "Surviving Smokefree".
Intervention Type
Behavioral
Intervention Name(s)
Florida Tobacco Quitline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants who meet inclusion criteria
Description
Percentage of participants who meet inclusion criteria
Time Frame
Baseline
Title
Percentage of participants who agree to participate in the study
Description
Percentage of participants who agree to participate in the study
Time Frame
Baseline
Title
Percentage of participants completing baseline assessment
Description
Percentage of participants completing baseline assessment
Time Frame
Baseline
Title
Percentage of participants completing the 3 month follow-up assessments
Description
Percentage of participants completing the 3 month follow-up assessments
Time Frame
at 3 months
Title
Percentage of participants completing the 6 month follow-up assessments
Description
Percentage of participants completing the 6 month follow-up assessments
Time Frame
at 6 months
Title
Treatment satisfaction - Acceptability
Description
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.
Time Frame
at 6 months
Title
Completion rate of MAPS calls for UC+MAPS+RP participants - Demand
Description
Percentage of MAPS calls completed for UC+MAPS+RP participants
Time Frame
at 6 months
Title
Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand
Description
Percentage of UC+MAPS+RP participants who viewed the web based video
Time Frame
at 3 months
Title
Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand
Description
Percentage of UC+MAPS+RP participants who viewed the web based video
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vani N Simmons, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer I Vidrine, PhD
Organizational Affiliation
Moffitt Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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