Back to search results

Smoking Cessation for Veterans with or at Risk for Cancer

This study is for Veterans who use tobacco and are either undergoing lung cancer screening or receiving cancer care. It aims to see how effective a program called Contingency Management (CM) is in helping Veterans quit smoking. CM is a behavioral treatment that uses rewards to encourage quitting, verified through biological testing. The study will also include behavioral counseling (Cognitive Behavioral Therapy, or CBT) and may involve focus groups to gather feedback. You could be eligible if you are an adult Veteran (18 years or older) who uses tobacco. The study will measure how well the program works by looking at things like your smoking habits and knowledge about quitting. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 108 participants. It involves different behavioral interventions, including focus groups, contingency management, and behavioral counseling.
What's involved
Participants will provide baseline data on substance use and smoking, upload videos verifying smoking abstinence daily, and receive weekly 15-20 minute counseling sessions for approximately five weeks. Some participants may also attend 60-minute focus groups.
Compensation
Not stated in the trial record.
Follow-up
Primary endpoints, such as focus groups and questionnaires, are measured at Baseline and Phase 1. The duration of follow-up after these initial measurements is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06432985

Smoking Cessation CM for Veterans With or at Risk for Cancer

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~108 participants
Updated 2025-09-30 on ClinicalTrials.gov
What's tested:Focus GroupContingency ManagementBehavioral Counseling (Cognitive Behavioral Therapy, CBT)TUD Treatment as Usual (TAU)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Focus Groups
Measured over Baseline
+14 more outcomes measured

Conditions

Tobacco Use Disorder
Substance Use Disorder

Explore related trials

Lung CarcinomaSolid NeoplasmTobacco Use Disorder

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Ellen Herbst, MD · PRINCIPAL_INVESTIGATOR · San Francisco VA Medical Center, San Francisco, CA

Who to contact

Ellen Herbst, MD
[email protected]
(415) 221-4810 · ext. 24926
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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.
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
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
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

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 1.5 hours (60 min focus group and self-report questionnaires)
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

What this trial measures

  • Focus GroupsBaseline

    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.

  • Veteran Nicotine and Tobacco Use QuestionnairePhase 1, Baseline

    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.

  • Smoking Knowledge, Attitudes and Practices Scale (S-KAP)Phase 1, Baseline

    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.

  • Participant Demographic QuestionnairePhases 2 & 3, Week 0

    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).

  • Session AttendancePhases 2 & 3, Up to 5 Weeks

    Study engagement will be assessed by tracking the number of participants attend each intervention session over the course of the 5-week intervention period. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models.

  • Remote (mobile) CO monitoringPhases 2 & 3, Weeks 2-5

    Study engagement will be assessed by the proportion of videos uploaded. Videos will be uploaded from Monday to Friday. It will be analyzed through bivariate associations with participant demographics. Differences over time in measurements will be examined using generalized mixed models.

  • Recruitment yield number of participants enrolledPhases 2 & 3, Up to 5 Weeks

    Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment.

  • Study RetentionPhases 2 & 3, 5 weeks

    Study retention as assessed by the number of participants that completed the study.

  • Timeline Follow-Back (TLFB): TUD medicationPhase 3, Weeks 0, 5, 12, 24

    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 quantity and frequency of use.

  • Change in Score on the Contemplation LadderPhase 3, Weeks 0, 5, 12, 24

    The Contemplation Ladder is a visual analog comprised of 11 rungs and 5 anchor statements, representing stages of change. The response options (0) to (3) corresponded with the stage of precontemplation, (4) to (6) represented the stage of contemplation, (7) and (8) referred to the stage of preparation, (9) and (10) represented the stage of action and stage of maintenance respectively. It is a brief measure of motivation or readiness to change, where (0) is the least motivated and (10) is the most motivated. This measure has been validated for cigarette and other substance use.

  • Changes in Nicotine and Tobacco Use SurveyPhase 3, Weeks 0, 5, 12, 24

    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, and presence of other tobacco users in the home and will be completed in Week 0. At Follow Ups (Weeks 5, 12 and 24), the survey will inquire about frequency and duration of quit attempts

  • Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)Phase 3, Weeks 0, 5, 12, 24

    The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.

  • Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief)Phase 3, Weeks 0, 5, 12, 24

    The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and scores are calculated by summing the item scores. The higher the total QSU score, the more intense are the participant's smoking urges.

  • Change in Timeline Followback (TLFB): TobaccoPhase 2 Weeks 0-6; Phase 3, Weeks 0-24

    Weekly self-reported use of cigarettes will be assessed with TLFB which uses a calendar with specific anchor dates to identify the quantity and frequency of use.

  • Change in carbon monoxide (CO) levelsPhases 2- 3, Weeks 2-5

    An iCO CO monitor will be used for the bio-verification of cigarette abstinence. Exhaled CO will be obtained using a study-issued iPad equipped with the iCO CO monitor and compatible app and the results will be shared through videos uploaded using VA-provided apps. Participants that report not smoking in the past 7 days and have CO levels \<6 parts per million (ppm) will be considered abstinent. For individuals with CO levels\> 6 ppm that report smoking cannabis who are not receiving NRT, salivary cotinine \<10 nanograms/ milliliter (ng/ml) will be used.