Contingency Management for Veteran Smokers With or at Risk for Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tobacco Use Disorder
- Sponsor
- VA Office of Research and Development
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Focus Groups
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Detailed Description
Smoking at the time of lung cancer screening (LCS) or cancer diagnosis is associated with treatment failure, shortened lifespan, and diminished quality of life. Beyond the increased morbidity and mortality, smoking after a cancer diagnosis is associated with an estimated $3.4 billion in healthcare costs. Despite these risks, the VA does not routinely integrate smoking cessation treatment into LCS screening or cancer care, and quit rates are low. 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.
Investigators
Eligibility Criteria
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.
- •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:
Exclusion Criteria
- •Focus Groups: For Focus Groups (Year 1), the investigators will recruit both Veterans and VA clinical staff at SFVAHCS.
- •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:
Outcomes
Primary Outcomes
Focus Groups
Time Frame: Baseline
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 Questionnaire
Time Frame: Phase 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)
Time Frame: 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 Questionnaire
Time Frame: Phases 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 Attendance
Time Frame: Phases 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 monitoring
Time Frame: Phases 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 enrolled
Time Frame: Phases 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 Retention
Time Frame: Phases 2 & 3, 5 weeks
Study retention as assessed by the number of participants that completed the study.
Change in Score on the Contemplation Ladder
Time Frame: Phase 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 Survey
Time Frame: Phase 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)
Time Frame: 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.
Timeline Follow-Back (TLFB): TUD medication
Time Frame: Phase 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 Scores on the Questionnaire on Smoking Urges (QSU-Brief)
Time Frame: 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): Tobacco
Time Frame: Phase 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) levels
Time Frame: Phases 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.
Secondary Outcomes
- 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)
- Mean Salivary Cotinine Levels(Phase 2 Weeks 2-6; Phase 3 Weeks 2-6, 12, and 24)