Smoking Cessation CM for Veterans With or at Risk for Cancer

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a program called Contingency Management (CM) to help Veterans quit smoking, especially during lung cancer screening or treatment. CM is a behavioral approach that uses rewards to motivate people to stop smoking, verified through biological tests. The first year will involve gathering feedback from Veterans and healthcare staff to create a mobile version of the CM program. In the second year, a small pilot study will test this program with 20 Veterans over five weeks. If successful, they will move on to a larger study comparing this mobile CM program with standard treatment over the next few years.

To participate, Veterans need to be 18 years or older, currently receiving care at the San Francisco VA Healthcare System, and actively smoking at least one cigarette a day. They should also have access to Wi-Fi and a device for video calls. Participants can expect to receive support through counseling and medications, along with the CM program. It's important to note that individuals with certain mental health conditions or those currently pregnant cannot take part in the study. This trial aims to find effective ways to help Veterans improve their health by quitting smoking.

Gender

ALL

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

Trial Officials