Smoking Relapse-Prevention Intervention for Cancer Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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Smoking Relapse-Prevention Intervention for Cancer Patients

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Usual Care
* Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Participants randomized to the Usual Care condition will receive standard care following recruitment. | Behavioral: Usual Care<br>* 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).<br>|
| Active Comparator: Relapse-Prevention Intervention<br>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)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Relapse at 6 Months | Number of participants with smoking relapse at 6 months follow-up for each treatment arm. | 6 Months | 
| Number of Participants with Relapse at 12 Months | Number of participants with smoking relapse at 12 months for each treatment arm. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relapse, prevention, smoking, habit, Forever Free