Contingency Management to Promote Smoking Abstinence in Cancer Patients

This is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Combination product: Contingency Management; Combination product: Standard Care

• Study Type: Interventional
• Enrollment (Estimated): 282
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maddie Foster; Phone Number: 8437371516; Email: fostemad@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Rachel Christian; Phone Number: 843-737-1516

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 or older
2. smoking 1 or more combustible tobacco products per day
3. diagnosed with or suspicion of any type of operable cancer

Exclusion Criteria:

1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia
2. non-English speaking
3. use of alternative nicotine delivery systems (e.g., e-cigarettes, snus, etc)
4. pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency Management	Combination product: Contingency Management; Participants will receive 3-6 counseling sessions, nicotine patches & lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
Active Comparator: Standard Care	Combination product: Standard Care; Participants will receive 3-6 counseling sessions, nicotine patches & lozenges, and CO breath test monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing	Abstinence will be defined by 7 days by self-report of no tobacco products, confirmed by CO breath test less than or equal to 4ppm and/or urine anabasine levels less than or equal to 2 ng/ml	Changes between the study intake appointment to day of surgery, up to five weeks apart

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing	Abstinence will be defined by 7 days by self-report of no tobacco products, confirmed by CO breath test less than or equal to 4ppm and/or urine anabasine levels less than or equal to 2 ng/ml	Three and Six months after surgery date

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Benjamin Toll, Medical University of South Carolina

Publications and helpful links

General Publications

• Rojewski AM, Fucito LM, Baker NL, Palmer AM, Foster MG, Warren GW, Bernstein SL, Toll BA. Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial. BMJ Open. 2021 Jun 29;11(6):e051226. doi: 10.1136/bmjopen-2021-051226.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 00099446; R01CA251158-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No