Smoking Relapse-Prevention Intervention for Cancer Patients

• ClinicalTrials.gov Identifier: NCT01630161
• Recruitment Status: Active, not recruiting
• First Posted: June 28, 2012
• Last Update Posted: May 12, 2020
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: Usual Care; Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP)	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 441 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Smoking Relapse-Prevention Intervention for Cancer Patients
• Actual Study Start Date: January 4, 2012
• Actual Primary Completion Date: May 15, 2015
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual Care; Participants randomized to the Usual Care condition will receive standard care following recruitment.	Behavioral: Usual Care; 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).
Active Comparator: Relapse-Prevention Intervention; 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.	Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP); 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).

Outcome Measures

Primary Outcome Measures :

1. Number of Participants with Relapse at 6 Months [ Time Frame: 6 Months ]
   Number of participants with smoking relapse at 6 months follow-up for each treatment arm.
2. Number of Participants with Relapse at 12 Months [ Time Frame: 12 Months ]
   Number of participants with smoking relapse at 12 months for each treatment arm.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Florida

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Vani Simmons, Ph.D.; H. Lee Moffitt Cancer Center and Research Institute

More Information

Additional Information:

Moffitt Cancer Center Clinical Trials website 

• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• ClinicalTrials.gov Identifier: NCT01630161
• Other Study ID Numbers: MCC-16458; 5R01CA154596-02 ( U.S. NIH Grant/Contract )
• First Posted: June 28, 2012
• Last Update Posted: May 12, 2020
• Last Verified: May 2020

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:

relapse; prevention; smoking; habit; Forever Free

Additional relevant MeSH terms:

Recurrence; Disease Attributes; Pathologic Processes