Smoking Relapse-Prevention Intervention for Cancer Patients
Primary Purpose
Smoking Cessation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
Smoking Relapse Prevention for Cancer Patients (SRP-CaP)
Sponsored by
About this trial
This is an interventional prevention trial for Smoking Cessation focused on measuring relapse, prevention, smoking, habit, Forever Free
Eligibility Criteria
Inclusion Criteria:
- Have smoked at least 10 cigarettes per day for at least one year prior to cancer diagnosis
- Able to read and write English
- Able to give informed consent
- Have quit smoking after receiving their cancer diagnosis
- Have not quit greater than 3 months prior
Exclusion Criteria:
- Individuals who have been abstinent for greater than 3 months are not included because they are less likely to relapse. A quit will be defined as self-reported no smoking for 24 hours. Individuals with metastatic disease will be excluded because participation in the study might be burdensome.
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual Care
Relapse-Prevention Intervention
Arm Description
Participants randomized to the Usual Care condition will receive standard care following recruitment.
Participants randomized to the Smoking Relapse Prevention for Cancer Patients (SRP-CaP) intervention will receive standard care plus our self-help smoking-relapse prevention materials.
Outcomes
Primary Outcome Measures
Number of Participants with Relapse at 6 Months
Number of participants with smoking relapse at 6 months follow-up for each treatment arm.
Number of Participants with Relapse at 12 Months
Number of participants with smoking relapse at 12 months for each treatment arm.
Secondary Outcome Measures
Full Information
NCT ID
NCT01630161
First Posted
June 26, 2012
Last Updated
August 16, 2021
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01630161
Brief Title
Smoking Relapse-Prevention Intervention for Cancer Patients
Official Title
Smoking Relapse-Prevention Intervention for Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2012 (Actual)
Primary Completion Date
May 15, 2015 (Actual)
Study Completion Date
November 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test different ways to help cancer patients maintain their smoking abstinence. Participants may receive educational materials as part of the study.
Detailed Description
This study involves participation at four distinct time points over a one-year period.
Baseline assessment
2-month follow-up telephone call
6-month follow-up telephone call
12-month follow-up telephone call
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
relapse, prevention, smoking, habit, Forever Free
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
441 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Participants randomized to the Usual Care condition will receive standard care following recruitment.
Arm Title
Relapse-Prevention Intervention
Arm Type
Active Comparator
Arm Description
Participants randomized to the Smoking Relapse Prevention for Cancer Patients (SRP-CaP) intervention will receive standard care plus our self-help smoking-relapse prevention materials.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Standard care includes routine assessment of smoking behavior and brief clinical intervention. Smoking counseling for all participants in the current study will be completed by a Certified Tobacco Treatment Specialist consisting consists of brief counseling (<15 minutes) based on the 5 A's Clinical Practice Guidelines; Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, Arrange for follow-up (Fiore et al., 2008). Patients receive information for local and state smoking resources (e.g., Quitline), pharmacotherapy options, and if interested, assistance with obtaining a prescription for pharmacotherapy. Follow-up with patients occurs at 2-weeks, only among those who are prescribed smoking medications (i.e., Varenicline, Bupropion).
Intervention Type
Behavioral
Intervention Name(s)
Smoking Relapse Prevention for Cancer Patients (SRP-CaP)
Intervention Description
The proposed multimodal intervention consists of a series of easy-to-read relapse prevention booklets (Forever Free) that have shown to be efficacious with a general smoking population (Brandon et al., 2000; 2004), and digital video disk (DVD) customized to the needs of cancer patients (to be developed in Year One).
Primary Outcome Measure Information:
Title
Number of Participants with Relapse at 6 Months
Description
Number of participants with smoking relapse at 6 months follow-up for each treatment arm.
Time Frame
6 Months
Title
Number of Participants with Relapse at 12 Months
Description
Number of participants with smoking relapse at 12 months for each treatment arm.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have smoked at least 10 cigarettes per day for at least one year prior to cancer diagnosis
Able to read and write English
Able to give informed consent
Have quit smoking after receiving their cancer diagnosis
Have not quit greater than 3 months prior
Exclusion Criteria:
Individuals who have been abstinent for greater than 3 months are not included because they are less likely to relapse. A quit will be defined as self-reported no smoking for 24 hours. Individuals with metastatic disease will be excluded because participation in the study might be burdensome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vani Simmons, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Smoking Relapse-Prevention Intervention for Cancer Patients
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