Contingency Management for Veteran Smokers With or at Risk for Cancer

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
United States
California
San Francisco VA Medical Center, San Francisco, CA
RECRUITING
San Francisco
Contact Information
Primary
Ellen Herbst, MD
Ellen.Herbst@va.gov
(415) 221-4810
Backup
Madeline Martinez Rivas, PhD
madeline.martinezrivas@va.gov
(415) 221-4810
Time Frame
Start Date: 2025-01-29
Estimated Completion Date: 2031-09-30
Participants
Target number of participants: 108
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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