Smoking Cessation CM for Veterans With or at Risk for Cancer
Contingency Management for Veteran Smokers With or at Risk for Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 5 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a mobile program that gives Veterans rewards for quitting smoking, with tests to confirm they have quit. The program includes counseling and medicine and is for Veterans getting lung cancer screening or cancer care at the San Francisco VA. Veterans and VA care staff will first share feedback to help build the program.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Veteran focus groups: Be eligible for VA health care and speak English.
- Veteran focus groups: Have had cancer monitoring, cancer treatment, or lung cancer screening at the San Francisco VA in the past 24 months.
- Veteran focus groups: Have smoked cigarettes within the past 24 months.
- Veteran focus groups: Have Wi-Fi and a device that supports sound and video calls.
- Staff focus groups: Work on the San Francisco VA care team and have cared for at least 5 VA cancer or lung cancer screening patients in the past 6 months.
- Treatment studies: Be an English-speaking Veteran getting care at the San Francisco VA, with at least one cancer care visit in the same calendar year.
- Treatment studies: Be enrolled in VA lung cancer screening or have a cancer diagnosis in VA records during the same calendar year.
- Treatment studies: Have smoked an average of at least 1 cigarette a day in the past 30 days and be open to help with quitting.
Who can't join
- Veteran focus groups: Have a severe, untreated mental illness; recent thoughts of suicide or harming others; or severe behavior problems that prevent taking part.
- Veteran focus groups: Have never smoked, quit more than 36 months before agreeing to join, or lack Wi-Fi or a device for sound and video calls.
- Staff focus groups: Cannot set aside about 45–60 minutes. Treatment studies: Cannot meet the study's time needs.
- Treatment studies: Have a mental or physical health condition that the study doctor judges unstable in the past 30 days, including one that large cash rewards could worsen.
- Treatment studies: Have a current, untreated gambling problem.
- Treatment studies: Have cancer that has spread to other parts of the body, or receive end-of-life or palliative care, which focuses on comfort and symptom relief.
- Treatment studies: Are pregnant or plan to become pregnant during the study.
- Treatment studies: Have attempted suicide or had suicidal thoughts with intent to act in the past 30 days, or are already in another quit-smoking clinical trial.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 lung cancer screening (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: * Veteran eligible for VA healthcare * English-speaking * Received SFVAHCS cancer monitoring or treatment or lung cancer screening (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: * 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 approximately 45-60 minutes (approx. 30-60 mins focus group/interview 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 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
Study sites (1)
CA
- San Francisco VA Medical Center, San Francisco, CA · San Francisco, CA 94121-1563Ellen Herbst, MD · Study contact · (415) 221-4810 ext. 24926 · Ellen.Herbst@va.govMadeline Martinez Rivas, PhD · Study contact · (415) 221-4810 ext. 24926 · madeline.martinezrivas@va.govEllen Herbst, MD · Principal investigatorMore trials in San Francisco