Smoking Relapse-Prevention Intervention for Cancer Patients

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Usual Care; Behavioral: Smoking Relapse Prevention for Cancer Patients (SRP-CaP)

• Registration Number: NCT01630161
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

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 Timeline

• Study Start: 2012-01-04
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Primary Completion: 2015-05-15
• Study Completion: 2020-11-18
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Participants randomized to the Usual Care condition will receive standard care following recruitment.
Relapse-Prevention Intervention	Smoking Relapse Prevention for Cancer Patients (SRP-CaP)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Relapse at 6 Months	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	12 Months	Number of participants with smoking relapse at 12 months for each treatment arm.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States