Smoking Relapse-Prevention Intervention for Cancer Patients

Smoking Cessation Clinical Trial

Official title:

Smoking Relapse-Prevention Intervention for Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630161
• Other study ID #: MCC-16458
• Secondary ID: 5R01CA154596-02
• Status: Completed
• Phase: N/A
• Start date: January 4, 2012
• Est. completion date: November 18, 2020

Study information

• Verified date: August 2021
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: November 18, 2020
• Est. primary completion date: May 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Smoking Cessation

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants with Relapse at 12 Months	Number of participants with smoking relapse at 12 months for each treatment arm.	12 Months

External Links

•   Moffitt Cancer Center Clinical Trials website