Smoking Cessation CM for Veterans With or at Risk for Cancer — CM_TUD_Cancer  

Tobacco Use Disorder Clinical Trial

Official title: Contingency Management for Veteran Smokers With or at Risk for Cancer

Status Not yet recruiting

Clinical Trial Summary

Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing. In the first year, the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. In the second year, they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period. The success of the pilot study will determine whether to proceed with a larger randomized controlled trial (RCT) in years three to six, comparing the efficacy of mobile CM with standard treatment. The project will take place at SFVA.

Clinical Trial Description

Smoking at the time of lung cancer screening (LCS) or cancer diagnosis is associated with treatment failure, shortened lifespan, and diminished quality of life. Beyond the increased morbidity and mortality, smoking after a cancer diagnosis is associated with an estimated $3.4 billion in healthcare costs. Despite these risks, the VA does not routinely integrate smoking cessation treatment into LCS screening or cancer care, and quit rates are low.

Contingency Management (C) is a behavioral therapy approach that reinforces desired behaviors, such as smoking cessation, through the provision of tangible rewards or incentives. The goal of this Proof of Concept and Clinical Trial project is to evaluate the acceptability, feasibility, and efficacy of Contingency Management (CM) for smoking cessation among Veterans in lung cancer screening (LCS) or cancer care in Veterans Affairs (VA) clinics.

Research indicates that CM must be tailored to the clinical population and context. This staged investigation will occur in three phases. First, the investigators will conduct Focus Groups, to iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff. Afterward, the investigators will conduct a Pilot Study to examine the feasibility of mobile smoking cessation CM with for VA patients in LCS or in cancer care. In a single arm study, Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. If successful, the investigators will conduct a Randomized Controlled Trial (RCT) to assess efficacy of mobile CM compared with treatment as usual (TAU). Veterans diagnosed with cancer or in LCS will be randomized to receive a 5-week CM condition (CM plus behavioral counseling) or TAU (referral to VA Tobacco Cessation Clinic and VA quitline). Both groups will receive pharmacotherapy.

The primary aims of this study are to develop an acceptable mobile CM protocol through qualitative feedback from Veterans and VA staff, to examine the feasibility of mobile smoking cessation CM among Veterans in LCS or cancer care through a pilot study, and to assess the efficacy of mobile CM compared to treatment as usual through a randomized controlled trial among Veterans diagnosed with cancer or in LCS. ;

Related Conditions & MeSH terms

• Substance Use Disorder
• Substance-Related Disorders
• Tobacco Use Disorder

• NCT number: NCT06432985
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Ellen Herbst, MD
• Phone: (415) 221-4810
• Email: Ellen.Herbst@va.gov
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 30, 2024
• Completion date: March 30, 2030