Smoking Relapse-Prevention Intervention for Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01630161
First received: June 26, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Smoking Cessation
Behavioral: Usual Care
Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Smoking Relapse-Prevention Intervention for Cancer Patients

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Number of Participants with Relapse at 6 Months [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Number of participants with smoking relapse at 6 months follow-up for each treatment arm.

  • Number of Participants with Relapse at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Number of participants with smoking relapse at 12 months for each treatment arm.


Estimated Enrollment: 444
Study Start Date: January 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630161

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Vani Simmons, Ph.D.    813-745-5498    vani.simmons@moffitt.org   
Principal Investigator: Vani Simmons, Ph.D.         
Sub-Investigator: Thomas Brandon, Ph.D.         
Sub-Investigator: Eric Haura, M.D., Ph.D.         
Sub-Investigator: Paul Jacobsen, Ph.D.         
Sub-Investigator: Judith McCaffrey, M.D.         
Sub-Investigator: Cathy Meade, R.N., Ph.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Vani Simmons, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01630161     History of Changes
Other Study ID Numbers: MCC-16458, 5R01CA154596-02
Study First Received: June 26, 2012
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
relapse
prevention
smoking
habit
Forever Free

ClinicalTrials.gov processed this record on August 28, 2014