Smoking Cessation CM for Veterans With or at Risk for Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Human Subjects Involvement and Characteristics: This Proof of Concept and Clinical Trial has three stages. The Proof-of-Concept Phase (Years 1-2) includes a Focus Group phase (Year 1) in which the investigators will recruit both Veterans and non-Veterans (VA clinical staff); and a Pilot Study (Year 2) in which the investigators will recruit Veterans in LCS or cancer treatment at San Francisco VA Healthcare System (SFVAHCS). If the Pilot Study is successful, the investigators will recruit Veterans in lung cancer screening (LCS) or cancer treatment for the RCT (Years 3-6).
Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
Veteran eligible for VA healthcare
English-speaking
Disqualifiers
Current severe, untreated mental illness (i.e., psychosis, bipolar disorder, and/or substance use disorder (SUD) and/or
Current (past 30 days) active suicidal/homicidal ideation or severe behavioral instability that would prevent participation
Never smokers or quit smoking for longer than 36 months prior to consent (4) no access to Wi-Fi or devices that support audio and video communication
Unable to commit approximately 45-60 minutes (approx. 30-60 mins focus group/interview and self-report questionnaires)
Trial design
Design model
Parallel
Treatments tested in this trial
Focus Group
BehavioralIn 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.
Contingency Management (CM)
BehavioralParticipants 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. Participants will also 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.
TUD Treatment as Usual (TAU)
BehavioralParticipants 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.
Treatment groups
108 Participants
are divided into 3 treatment groupsGroup A: Focus GroupOther 1 intervention
Group B: Contingency Management (CM)Experimental treatment 1 intervention
Group C: TUD Treatment as Usual (TAU)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Focus Groups
Audio recordings will be analyzed by the research team using a template-based rapid analysis technique developed for health services research. A structured summary will be prepared, organized by topical areas drawn from the interview/focus group guide, to identify and describe themes within each topical domain.
Time frame
Baseline2
Veteran Nicotine and Tobacco Use Questionnaire
Assesses age at first use, duration of use, use of all forms of nicotine and tobacco, prior quit attempts (defined as a period of intentionally not smoking for 24 hours), duration of cessation (if any), and presence of other tobacco users in the home. It will be used in the analytic process to correlate findings/themes with characteristics.
Time frame
Phase 1, Baseline3
Smoking Knowledge, Attitudes and Practices Scale (S-KAP)
It is a validated 46 item instrument that evaluates smoking-related knowledge, beliefs, self-efficacy, cessation treatment practices, and barriers to cessation treatment delivery among healthcare providers. The scores are from the summed items. Higher scores equal more tobacco treatment and the range of scores is 0-26.
Time frame
Phase 1, Baseline4
Participant Demographic Questionnaire
Assesses age, gender identity, sexual orientation, ethnicity, race, relationship status, income, education level, military history, service-connected disability status, housing status, and employment status. It will be analyzed through bivariate associations with outcomes (attendance, rate of video uploads).
Time frame
Phases 2 & 3, Week 0Secondary outcomes
1
Timeline Follow-Back (TLFB): Other substances
Self-reported use of other substances will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the quantity of use.
Time frame
Phase 2 Weeks 0-6; Phase 3, Weeks 0-242
Change in Timeline Follow-Back (TLFB): TUD medication
Self-reported use of medication for tobacco use disorder will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the frequency of use.
Time frame
Phase 2 Weeks 0-63
Change in Timeline Follow-Back (TLFB): E-cigarettes
Self-reported use of e-cigarettes will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the quantity of use.
Time frame
Phase 2 Weeks 0-6; Phase 3, Weeks 0-244
Change in Timeline Follow-Back (TLFB): Other tobacco products
Self-reported use of any other tobacco products will be assessed with TLFB, which uses a calendar with specific anchor dates to identify the quantity of use.
Time frame
Phase 2 Weeks 0-6; Phase 3, Weeks 0-24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov