Trial Title:
Smoking Cessation CM for Veterans With or at Risk for Cancer
NCT ID:
NCT06432985
Condition:
Tobacco Use Disorder
Substance Use Disorder
Conditions: Official terms:
Substance-Related Disorders
Tobacco Use Disorder
Conditions: Keywords:
Tobacco
Contingency Management
Lung Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
Double-blind Masking
Intervention:
Intervention type:
Behavioral
Intervention name:
Focus Group
Description:
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.
Arm group label:
Focus Group
Intervention type:
Behavioral
Intervention name:
Contingency Management
Description:
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.
Arm group label:
Contingency Management
Intervention type:
Behavioral
Intervention name:
Behavioral Counseling (Cognitive Behavioral Therapy, CBT)
Description:
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.
Arm group label:
Contingency Management
Arm group label:
TUD Treatment as Usual
Intervention type:
Behavioral
Intervention name:
TUD Treatment as Usual (TAU)
Description:
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.
Arm group label:
TUD Treatment as Usual
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
San Francisco VA Medical Center, San Francisco, CA
Address:
City:
San Francisco
Zip:
94121-1563
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ellen Herbst, MD
Phone:
415-221-4810
Phone ext:
24926
Email:
Ellen.Herbst@va.gov
Contact backup:
Last name:
Madeline Martinez Rivas, PhD
Phone:
(415) 221-4810
Phone ext:
24926
Email:
madeline.martinezrivas@va.gov
Investigator:
Last name:
Ellen Herbst, MD
Email:
Principal Investigator
Start date:
October 1, 2024
Completion date:
March 30, 2030
Lead sponsor:
Agency:
VA Office of Research and Development
Agency class:
U.S. Fed
Collaborator:
Agency:
University of California, San Francisco
Agency class:
Other
Source:
VA Office of Research and Development
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06432985
https://addictionresearch.ucsf.edu/
