Smoking Cessation CM for Veterans With or at Risk for Cancer
NCT ID: NCT06432985
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2025-01-29
2031-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Focus Group
The investigators will 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.
Focus 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.
Contingency Management
Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks.
Contingency 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.
Behavioral 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.
TUD Treatment as Usual
Participants assigned to TAU will receive time-matched Medication Management plus usual care (referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline).
Behavioral 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.
TUD 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.
Interventions
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Focus 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.
Contingency 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.
Behavioral 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.
TUD 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
Veterans:
* Age 18 years or older
* Veteran eligible for VA healthcare
* English-speaking
* Received SFVAHCS cancer monitoring or treatment or LCS within the past 24 months
* Active cigarette smoking within the past 24 months
* Have access to Wi-Fi and a device that supports audio and video communication
VA Clinical Staff:
* Current member of clinical staff at the SFVAHCS
* Have participated in the care of at least 5 VA cancer or LCS patients in the past 6 months
Pilot Feasibility Study (Year 2) and Randomized Controlled Trial
* Age 18 years or older
* Veteran currently receiving medical care at SFVAHCS (at least one clinical visit same calendar year for cancer)
* English-speaking
* Current, active (same calendar year) enrollment in VA LCS, or current (same calendar year) diagnosis of cancer documented in the VA medical record, confirmed through medical record review
* Current (past 30 days) cigarette smoking a minimum of 1 cigarette per day (average), assessed by Timeline Followback (TLFB)92, 99-101
* Open to receiving smoking cessation interventions
Exclusion Criteria
Veterans:
* 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
VA Clinical Staff:
* Unable to commit 1.5 hours (60 min focus group and self-report questionnaires)
Pilot Feasibility Study (Year 2) and Randomized Controlled Trial
* An individual who meets any of the following criteria will be excluded from participation in this study:
* Evaluated by investigative team medical record review and clinical assessment:
* Psychotic disorders, bipolar disorder, neurocognitive disorder, substance use disorders, or other psychiatric or medical conditions judged by the PI to be unstable in the past 30 days, based on screening results and/or medical record review, including conditions for which large sums of money would be potentially destabilizing
* Untreated, current, active problem gambling, assessed by medical record diagnosis and/ or Problem Gambling Severity Index (PGSI) score 8
* Metastatic cancer or enrollment in end of life/ palliative care
* Unable to commit to time commitment required for participation
* Currently pregnant or planning to become pregnant during the study (people of childbearing potential ages 18-55 who are pregnant or state that they plan to become pregnant during the study)
* A suicide attempt or suicidal ideation with intent in the 30 days prior to enrollment
* Concurrent enrollment in a tobacco cessation clinical trial
18 Years
ALL
Yes
Sponsors
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University of California, San Francisco
OTHER
VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Ellen Herbst, MD
Role: PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA
Locations
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San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Provides Link to CM\_TUD\_Cancer Study
Other Identifiers
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24-40951
Identifier Type: OTHER
Identifier Source: secondary_id
NURA-006-23F
Identifier Type: -
Identifier Source: org_study_id
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