NCT04605458

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

September 25, 2020

Last Update Submit

March 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Abstinence Rates as assessed by self-report for past 7 days, Carbon Monoxide Breath Monitoring and/or Anabasine testing

    Three and Six months after surgery date

Study Arms (2)

Contingency Management

EXPERIMENTAL
Combination Product: Contingency Management

Standard Care

ACTIVE COMPARATOR
Combination Product: Standard Care

Interventions

Contingency ManagementCOMBINATION_PRODUCT

Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.

Contingency Management
Standard CareCOMBINATION_PRODUCT

Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring.

Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Benjamin Toll

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 28, 2020

Study Start

November 25, 2020

Primary Completion

July 10, 2025

Study Completion

December 18, 2025

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations