Tobacco Use Disorder Clinical Trial
— CM_TUD_CancerOfficial title:
Contingency Management for Veteran Smokers With or at Risk for Cancer
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.
Status | Not yet recruiting |
Enrollment | 95 |
Est. completion date | March 30, 2030 |
Est. primary completion date | March 30, 2030 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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 Inclusion criteria: - 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: Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS. Veterans: Exclusion criteria: Assessed by Co-PIs' medical record review: - 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: Exclusion Criteria: - Unable to commit 1.5 hours (60 min focus group and self-report questionnaires) Pilot Feasibility Study (Year 2) and Randomized Controlled Trial Exclusion Criteria: - 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 M.I.N.I. Neuropsychiatric Inventory (M.I.N.I.) 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 |
Country | Name | City | State |
---|---|---|---|
United States | San Francisco VA Medical Center, San Francisco, CA | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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). | Phase 2, week 0 | |
Primary | 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. | Up to 5 Weeks | |
Primary | 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. | Phase 2, Weeks 2-5 | |
Primary | Recruitment yield number of participants enrolled | Study feasibility will be assessed by recruitment yield, i.e., tracking the number of participants who initiated treatment. | Phase 2, Up to 5 Weeks | |
Primary | Study Retention | Study retention as assessed by the number of participants that completed the study. | Phase 2, 5 weeks | |
Primary | 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 outcome variables and primary independent variables. | Phase 3, week 0 | |
Primary | Timeline Follow-Back (TLFB): TUD medication | Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. | Phase 3, Weeks 0, 5, 12, 24 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 3, Weeks 2-5 | |
Primary | Change in Timeline Followback (TLFB): Tobacco | Self-reported use of tobacco will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity and frequency of use. | Phase 3, Weeks 12, 24 | |
Primary | 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. | Phase 3, Weeks 2-5 | |
Primary | Mean Salivary Cotinine Levels | Salivary Cotinine levels are an established method to biochemically verify a participant's smoking status. Participants will follow instructions provided to them in plain language describing procedures to test saliva for the presence or absence of cotinine to confirm abstinence. The cotinine test has several zones (0-6). Any result of with color in Zone 0 will be considered negative for tobacco use. | Phase 3, Weeks 5, 12, 24 | |
Secondary | Timeline Follow-Back (TLFB): Other substances | Self-reported use of other substances will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use. | Phase 2, Weeks 0, 5 | |
Secondary | Change in Timeline Follow-Back (TLFB): TUD medication | Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use. | Phase 2, Weeks 0, 5 | |
Secondary | Change in Timeline Follow-Back (TLFB): E-cigarettes | Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use. | Phase 2, Weeks 0, 5 | |
Secondary | Change in Timeline Follow-Back (TLFB): Other tobacco products | Self-reported use of any other tobacco products will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity of use. | Phase 2, Weeks 0, 5 | |
Secondary | Change in Percentage of Participants with Point Prevalent Abstinence | Seven-day point prevalence cigarette abstinence will be defined as the percentage of participants who have reported no smoking or nicotine use on the 7 consecutive days prior to the assessment with biochemically verified cotinine levels of < 10 nanograms/ milliliter. | Phase 3, Weeks 5, 12, 24 | |
Secondary | Timeline Follow-Back (TLFB): Other substances | Self-reported use of other substances will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use. | Phase 2, Weeks 0, 5 | |
Secondary | Change in Timeline Follow-Back (TLFB): TUD medication | Self-reported use of medication for tobacco use disorder will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the quantity use. | Phase 2, Weeks 0, 5 | |
Secondary | Change in Timeline Follow-Back (TLFB): E-cigarettes | Self-reported use of e-cigarettes will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use. | Phase 2, Weeks 0, 5 | |
Secondary | Change in Timeline Follow-Back (TLFB): Other tobacco products | Self-reported use of any other tobacco products will be assessed with TLFB (past 30 days), which uses a calendar with specific anchor dates to identify the frequency of use. | Phase 2, Weeks 0, 5 |
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