Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery

NCT ID: NCT02402023

Last Updated: 2020-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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The investigators are proposing a developmental interdisciplinary pilot study to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery. This study (a follow up to smaller pilot studies) will serve as a means to further develop a treatment protocol and to generate an accurate effect size for a full scale trial. The present study will constitute a development clinical trial with a primary aim of developing an effect size for smoking cessation at the time of surgery (7-day point prevalence abstinence), and a secondary aim of creating an effect size for long-term abstinence at 3 months post-surgery.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard Care (SC)

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

Group Type ACTIVE_COMPARATOR

Standard of Care (SC)

Intervention Type BEHAVIORAL

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

Contingency Management (CM)

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

Group Type EXPERIMENTAL

Contingency Management (CM)

Intervention Type BEHAVIORAL

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

Standard of Care (SC)

Intervention Type BEHAVIORAL

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

Interventions

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Contingency Management (CM)

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

Intervention Type BEHAVIORAL

Standard of Care (SC)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. age 18 or older
2. smoking ≥ 1 cigarettes per day
3. CO \> 6 ppm
4. diagnosed with or suspicion of any type of operable thoracic, head and neck, breast, or gynecologic cancer
5. 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.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Toll, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R21CA181569

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1407014258

Identifier Type: -

Identifier Source: org_study_id

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