RecruitingNot ApplicableNCT06432985

Smoking Cessation CM for Veterans With or at Risk for Cancer

Contingency Management for Veteran Smokers With or at Risk for Cancer

Sponsor

VA Office of Research and Development

Enrollment

108 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Tobacco Use Disorder Substance Use Disorder

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria20

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
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 Criteria17

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)
A suicide attempt or suicidal ideation with intent in the 30 days prior to enrollment
Concurrent enrollment in a tobacco cessation clinical trial

Interventions

BEHAVIORALFocus Group

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.

BEHAVIORALContingency Management

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.

BEHAVIORALBehavioral Counseling (Cognitive Behavioral Therapy, CBT)

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.

BEHAVIORALTUD Treatment as Usual (TAU)

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.