Helping Veterans quit smoking during cancer care

Contingency Management for Veteran Smokers With or at Risk for Cancer

This study is testing a new program to help Veterans quit smoking while they are being screened or treated for lung cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VA Office of Research and Development (Federal)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06432985 on ClinicalTrials.gov

What this trial studies

This project aims to evaluate the effectiveness of a Contingency Management (CM) program designed to assist Veterans in quitting smoking while undergoing lung cancer screening or treatment. The study will first develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. Following this, a pilot study will test the feasibility of the mobile CM program combined with counseling and medication for 20 Veterans over five weeks. If successful, the findings will inform a larger randomized controlled trial comparing mobile CM to standard treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are Veterans aged 18 and older who are eligible for VA healthcare and have received cancer monitoring or treatment within the past 24 months.

Not a fit: Patients who are not Veterans or those who do not speak English may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve smoking cessation rates among Veterans, leading to better health outcomes and quality of life.

How similar studies have performed: Other studies have shown promise with similar behavioral interventions, suggesting that this approach could be effective.

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 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

Where this trial is running

San Francisco, California

• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Ellen Herbst, MD — San Francisco VA Medical Center, San Francisco, CA
• Study coordinator: Ellen Herbst, MD

Conditions Tobacco Use Disorder; Substance Use Disorder; Tobacco; Contingency Management; Lung Cancer