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Completed

NCT Number: NCT01630161

Smoking Relapse-Prevention Intervention for Cancer Patients

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.

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Key information

Conditions

Smoking Cessation Behavior Disease Attributes Habits Health Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual Care

Behavioral

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)

Behavioral

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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2020
First posted
Jun 28, 2012
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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