Clinical trial NCT06432985: Smoking Cessation CM for Veterans With or at Risk for Cancer
Official title: Contingency Management for Veteran Smokers With or at Risk for Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Substance Use Disorder
Keywords: Tobacco
Contingency Management
Lung Cancer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, San Francisco
First posted: 2024-05-29
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Focus Groups
timeFrame: Baseline
measure: Veteran Nicotine and Tobacco Use Questionnaire
timeFrame: Phase 1, Baseline
measure: Smoking Knowledge, Attitudes and Practices Scale (S-KAP)
timeFrame: Phase 1, Baseline
measure: Participant Demographic Questionnaire
timeFrame: Phase 2, week 0
measure: Session Attendance
timeFrame: Up to 5 Weeks
measure: Remote (mobile) CO monitoring
timeFrame: Phase 2, Weeks 2-5
measure: Recruitment yield number of participants enrolled
timeFrame: Phase 2, Up to 5 Weeks
measure: Study Retention
timeFrame: Phase 2, 5 weeks
measure: Participant Demographic Questionnaire
timeFrame: Phase 3, week 0
measure: Timeline Follow-Back (TLFB): TUD medication
timeFrame: Phase 3, Weeks 0, 5, 12, 24
measure: Change in Score on the Contemplation Ladder
timeFrame: Phase 3, Weeks 0, 5, 12, 24
measure: Changes in Nicotine and Tobacco Use Survey
timeFrame: Phase 3, Weeks 0, 5, 12, 24
measure: Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)
timeFrame: Phase 3, Weeks 0, 5, 12, 24
measure: Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief)
timeFrame: Phase 3, Weeks 0, 5, 12, 24
measure: Change in Timeline Followback (TLFB): Tobacco
timeFrame: Phase 3, Weeks 2-5
measure: Change in Timeline Followback (TLFB): Tobacco
timeFrame: Phase 3, Weeks 12, 24
measure: Change in carbon monoxide (CO) levels
timeFrame: Phase 3, Weeks 2-5
measure: Mean Salivary Cotinine Levels
timeFrame: Phase 3, Weeks 5, 12, 24
Secondary outcomes:
measure: Timeline Follow-Back (TLFB): Other substances
timeFrame: Phase 2, Weeks 0, 5
measure: Change in Timeline Follow-Back (TLFB): TUD medication
timeFrame: Phase 2, Weeks 0, 5
measure: Change in Timeline Follow-Back (TLFB): E-cigarettes
timeFrame: Phase 2, Weeks 0, 5
measure: Change in Timeline Follow-Back (TLFB): Other tobacco products
timeFrame: Phase 2, Weeks 0, 5
measure: Change in Percentage of Participants with Point Prevalent Abstinence
timeFrame: Phase 3, Weeks 5, 12, 24
measure: Timeline Follow-Back (TLFB): Other substances
timeFrame: Phase 2, Weeks 0, 5
measure: Change in Timeline Follow-Back (TLFB): TUD medication
timeFrame: Phase 2, Weeks 0, 5
measure: Change in Timeline Follow-Back (TLFB): E-cigarettes
timeFrame: Phase 2, Weeks 0, 5
measure: Change in Timeline Follow-Back (TLFB): Other tobacco products
timeFrame: Phase 2, Weeks 0, 5
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
Study officials:
affiliation: San Francisco VA Medical Center, San Francisco, CA
name: Ellen Herbst, MD
role: PRINCIPAL_INVESTIGATOR
References: