NCT02402023

Brief Summary

The purpose of this clinical trial is to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

2.9 years

First QC Date

November 17, 2014

Last Update Submit

March 4, 2020

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Pre Surgery Smoking Abstinence

    Participants will be classified as succeeded or failed in cessation based on a definition of 1 week of abstinence from cigarettes leading up to the day of their surgery based on self-report and confirmed with biochemical verification (CO≤6ppm). For participants who are classified as abstinent, a chi-square will be computed comparing whether treatment with CM is superior to SC in producing a higher probability of abstinence. These data will be used to compute an effect size, Cohen's w, for smoking cessation.

    Day of Surgery

Secondary Outcomes (1)

  • Post Surgery Smoking Abstinence

    3 months

Other Outcomes (2)

  • Continuous Smoking Abstinence

    3 months

  • Perioperative Complications

    3 months

Study Arms (2)

Standard Care (SC)

ACTIVE COMPARATOR

Patients in the SC arm will receive 4 counseling sessions and nicotine patches as part of typical cessation measures delivered to patients.

Behavioral: Standard of Care (SC)

Contingency Management (CM)

EXPERIMENTAL

Patients in the CM arm will receive monetary payment contingent on smoking abstinence (in addition to SC: 4 counseling sessions and nicotine patches).

Behavioral: Contingency Management (CM)Behavioral: Standard of Care (SC)

Interventions

Contingency Management (CM)BEHAVIORAL

CM is standard care plus monetary payment delivered contingent on abstinence.

Contingency Management (CM)
Standard of Care (SC)BEHAVIORAL

Standard of care consists of smoking cessation counseling sessions and nicotine patches.

Contingency Management (CM)Standard Care (SC)

Eligibility Criteria

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

You may qualify if:

  • age 18 or older
  • smoking ≥ 1 cigarettes per day
  • CO \> 6 ppm
  • diagnosed with or suspicion of any type of operable thoracic, head and neck, breast, or gynecologic cancer
  • agreement on a 2-5-week pre-surgical tobacco intervention by both patient and surgeon, and 6) residence within reasonable driving distance to New Haven.

You may not qualify if:

  • unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
  • unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days
  • pregnant or breastfeeding women
  • those with limited decision making capacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-8350, United States

Location

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, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

March 30, 2015

Study Start

October 1, 2014

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

US(2)