Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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: 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".
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.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants who meet inclusion criteria [Baseline]
Percentage of participants who meet inclusion criteria
- Percentage of participants who agree to participate in the study [Baseline]
Percentage of participants who agree to participate in the study
- Percentage of participants completing baseline assessment [Baseline]
Percentage of participants completing baseline assessment
- Percentage of participants completing the 3 month follow-up assessments [at 3 months]
Percentage of participants completing the 3 month follow-up assessments
- Percentage of participants completing the 6 month follow-up assessments [at 6 months]
Percentage of participants completing the 6 month follow-up assessments
- Treatment satisfaction - Acceptability [at 6 months]
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 [at 6 months]
Percentage of MAPS calls completed for UC+MAPS+RP participants
- Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand [at 3 months]
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 [at 6 months]
Percentage of UC+MAPS+RP participants who viewed the web based video
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moffitt Cancer Center | Tampa | Florida | United States | 33617 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-21108