Smoking Cessation CM for Veterans With or at Risk for Cancer

NCT06432985 | Recruiting DMC

• 2 other identifiers: NURA-006-23F24-40951
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use Disorder; Substance Use Disorder

Keywords

Tobacco; Contingency Management; Lung Cancer

Outcome Measures

Primary Outcomes (15)

• 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.

  Baseline

• 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.

  Phase 1, Baseline

• 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.

  Phase 1, Baseline

• 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).

  Phases 2 & 3, Week 0

• Session Attendance

  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.

  Phases 2 & 3, Up to 5 Weeks

• Remote (mobile) CO monitoring

  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.

  Phases 2 & 3, Weeks 2-5

• Recruitment yield number of participants enrolled

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

  Phases 2 & 3, Up to 5 Weeks

• Study Retention

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

  Phases 2 & 3, 5 weeks

• 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 quantity and frequency of use.

  Phase 3, Weeks 0, 5, 12, 24

• Change in Score on the Contemplation Ladder

  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.

  Phase 3, Weeks 0, 5, 12, 24

• Changes in Nicotine and Tobacco Use Survey

  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

  Phase 3, Weeks 0, 5, 12, 24

• Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)

  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.

  Phase 3, Weeks 0, 5, 12, 24

• Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief)

  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.

  Phase 3, Weeks 0, 5, 12, 24

• Change in Timeline Followback (TLFB): Tobacco

  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.

  Phase 2 Weeks 0-6; Phase 3, Weeks 0-24

• Change in carbon monoxide (CO) levels

  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.

  Phases 2- 3, Weeks 2-5

Secondary Outcomes (6)

• Timeline Follow-Back (TLFB): Other substances

  Phase 2 Weeks 0-6; Phase 3, Weeks 0-24

• Change in Timeline Follow-Back (TLFB): TUD medication

  Phase 2 Weeks 0-6

• Change in Timeline Follow-Back (TLFB): E-cigarettes

  Phase 2 Weeks 0-6; Phase 3, Weeks 0-24

• Change in Timeline Follow-Back (TLFB): Other tobacco products

  Phase 2 Weeks 0-6; Phase 3, Weeks 0-24

• Change in Percentage of Participants with Point Prevalent Abstinence

  Phase 2, Week 5; Phase 3, Weeks 5-24

Study Arms (3)

Focus Group

OTHER

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.

Behavioral: Focus Group

Contingency Management

EXPERIMENTAL

Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks.

Behavioral: Contingency Management; Behavioral: Behavioral Counseling (Cognitive Behavioral Therapy, CBT)

TUD Treatment as Usual

ACTIVE COMPARATOR

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: Behavioral Counseling (Cognitive Behavioral Therapy, CBT); Behavioral: TUD Treatment as Usual (TAU)

Interventions

Focus Group BEHAVIORAL

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.

Focus Group

Contingency Management BEHAVIORAL

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.

Contingency Management

Behavioral Counseling (Cognitive Behavioral Therapy, CBT) BEHAVIORAL

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.

Contingency Management; TUD Treatment as Usual

TUD Treatment as Usual (TAU) BEHAVIORAL

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.

TUD Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following 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

You may not qualify if:

• Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of California, San Francisco: collaborator

Study Sites (1)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

RECRUITING

Related Links

• Provides Link to CM\_TUD\_Cancer Study

MeSH Terms

Conditions

Tobacco Use Disorder; Substance-Related Disorders; Lung Neoplasms

Interventions

Focus Groups; Behavior Therapy; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ellen Herbst, MD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Herbst, MD

CONTACT

(415) 221-4810; Ellen.Herbst@va.gov

Madeline Martinez Rivas, PhD

CONTACT

(415) 221-4810; madeline.martinezrivas@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 29, 2024
• Study Start: January 29, 2025
• Primary Completion (Estimated): August 15, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)