Smoking Cessation CM for Veterans With or at Risk for Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06432985
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Focus Group — BEHAVIORAL
    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.
  • Contingency Management — BEHAVIORAL
    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.
  • Behavioral Counseling (Cognitive Behavioral Therapy, CBT) — BEHAVIORAL
    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.
  • TUD Treatment as Usual (TAU) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 29, 2025
Status verified
Sep 2025
Primary completion
Aug 15, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Focus Group
    The investigators will 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.
  • Experimental: Contingency Management
    Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks.
  • Active Comparator: TUD Treatment as Usual
    Participants assigned to TAU will receive time-matched Medication Management plus usual care (referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline).

Primary Outcome Measure

Focus Groups [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Ellen Herbst, MD
[email protected]
415-221-4810
Madeline Martinez Rivas, PhD
[email protected]
(415) 221-4810
Ellen Herbst, MD (PRINCIPAL_INVESTIGATOR)

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