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Smoking Relapse-Prevention Intervention for Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01630161
First Posted: June 28, 2012
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
  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
Smoking Cessation Behavioral: Usual Care Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    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 ]
    Number of participants with smoking relapse at 12 months for each treatment arm.


Enrollment: 441
Actual Study Start Date: January 4, 2012
Estimated Study Completion Date: December 2018
Primary Completion Date: June 8, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630161


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:
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 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2012
First Posted: June 28, 2012
Last Update Posted: July 2, 2017
Last Verified: June 2017

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