Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatments usual care, smoking relapse prevention for cancer patients (srp-cap)
Phase phase 2
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborator National Cancer Institute (NCI)
Start date January 2012
End date March 2017
Trial size 441 participants
Trial identifier NCT01630161, 5R01CA154596-02, MCC-16458

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Participants randomized to the Usual Care condition will receive standard care following recruitment.
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)
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.
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).

Primary Outcomes

Measure
Number of Participants with Relapse at 6 Months
time frame: 6 Months
Number of Participants with Relapse at 12 Months
time frame: 12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Smoking Relapse-Prevention Intervention for Cancer Patients
Principal investigator Vani Simmons, Ph.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.