RecruitingNot ApplicableNCT06432985

Smoking Cessation CM for Veterans With or at Risk for Cancer

Contingency Management for Veteran Smokers With or at Risk for Cancer


Sponsor

VA Office of Research and Development

Enrollment

108 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and testing a smoking cessation program specifically designed for veterans who are undergoing lung cancer screening or cancer treatment at the San Francisco VA Health Care System. **You may be eligible if...** - You are a veteran receiving care at the San Francisco VA - You are currently undergoing lung cancer screening or cancer treatment - You are a current smoker interested in quitting - (In early phases) VA clinical staff may also be invited to participate in focus groups **You may NOT be eligible if...** - You are not affiliated with the VA health system for this study - You do not smoke or are not interested in smoking cessation support - You do not meet the specific criteria for each phase of the study (focus groups, pilot, or full trial) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALFocus Group

In 60-minute focus groups, participants will be categorized based on their survey responses and engaged in semi-structured discussions using open-ended questions and probes to gather detailed information. The moderators will follow best practices in qualitative research, introducing the topic of smoking cessation in the context of cancer screening and treatment and guiding the discussions from broader issues to participant-generated examples.

BEHAVIORALContingency Management

Participants will provide baseline data on their recent substance use and smoking habits and severity. They will receive a CO monitor and iCO app and will upload videos verifying smoking abstinence a minimum of once per day, 5 times per week. Financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through Remote (mobile) CO monitoring. They will receive clinician feedback at the time of each CO reading, following established VA protocols for CM.

BEHAVIORALBehavioral Counseling (Cognitive Behavioral Therapy, CBT)

Participants will receive a 5-session smoking cessation behavioral counseling for approximately 15-20 minutes weekly. Sessions may be held by secure video conference or by telephone, per participant preference. Sessions will use CBT principles with MI incorporated for resolving reluctance to quit.

BEHAVIORALTUD Treatment as Usual (TAU)

Participants assigned to TAU will receive referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline. The VA Tobacco Cessation Clinic is modeled after VA Tobacco Cessation Clinics across all VA facilities and involves delivery of brief counseling and pharmacotherapy for TUD if desired. VA Telequit is a national toll-free number available to Veterans that allows them to speak with a smoking cessation counselor for a recommended minimum of five sessions to develop a quit plan and receive counseling, strategies to prevent relapse, and weekly proactive follow-up calls based on National Cancer Institute guidelines.


Locations(1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

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NCT06432985


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