Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program

September 12, 2019 updated by: Duke University

Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program

The purpose of this study is to conduct an observational assessment of natural outcomes within the Duke Smoking Cessation Program (DSCP), "Quit at Duke." This assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. Primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The purpose of this study is to conduct an observational assessment of natural outcomes within the DSCP, "Quit at Duke." This is an observational study (n=3000) on patients being treated at the DSCP. No interventions are conducted, and data analyzed is collected in the course of clinical care at clinic visits to the Duke Smoking Cessation Program (DSCP). Phone calls are also conducted to determine response to medications and abstinence status up to 12 months following a quit attempt. Outcomes of variables including: demographic variables, evaluation responses, feasibility data, and abstinence rates will be analyzed using general regression models using an ANOVA-based design. Because no intervention is being conducted, there are no safety concerns related to the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Smoking Cessation Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will recruit participants through Quit at Duke, also called the Duke Smoking Cessation Program (DSCP). The DSCP is a growing multi-clinic tobacco use treatment program. The initial clinic site is at Duke Cancer Center, but it is positioned to expand over the next several years to include several other clinic sites within the Duke University Health System (DUHS). There are no exclusion criteria for this study.

Description

Inclusion Criteria:

  • Age 18 or older
  • Being treated at the Duke Smoking Cessation Program
  • Fluent in written and spoken English.

Exclusion Criteria: N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Participants
All participants are patients within the Quit at Duke Smoking Cessation Program. This is an observational study with no interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biochemically confirmed continuous 30-day abstinence from smoking
Time Frame: 12 weeks post-Target Quit Day (TQD)
Biochemically confirmed 30-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 30 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
12 weeks post-Target Quit Day (TQD)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemically confirmed 7-day point prevalence abstinence from smoking
Time Frame: 2 weeks post-TQD
Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
2 weeks post-TQD
Biochemically confirmed 7-day point prevalence abstinence from smoking
Time Frame: 12 weeks post-TQD
Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent
12 weeks post-TQD
Self-report 7-day point prevalence abstinence from smoking
Time Frame: 1 day post-TQD
7-day point prevalence abstinence as measured by phone-based, single-item self-report
1 day post-TQD
Self-report 7-day point prevalence abstinence from smoking
Time Frame: 1 week post-TQD
7-day point prevalence abstinence as measured by phone-based, single-item self-report
1 week post-TQD
Self-report 7-day point prevalence abstinence from smoking
Time Frame: 6 month post-TQD
7-day point prevalence abstinence as measured by phone-based, single-item self-report
6 month post-TQD
Self-report 7-day point prevalence abstinence from smoking
Time Frame: 12 month post-TQD
7-day point prevalence abstinence as measured by phone-based, single-item self-report
12 month post-TQD
Smoking reduction
Time Frame: 1 day post-TQD
Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
1 day post-TQD
Smoking reduction
Time Frame: 1 week post-TQD
Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
1 week post-TQD
Smoking reduction
Time Frame: 6 months post-TQD
Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
6 months post-TQD
Smoking reduction
Time Frame: 12 months post-TQD
Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report
12 months post-TQD
Changes in stress
Time Frame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
Change in self-reported measures of stress, as measured by Perceived Stress Scale
Baseline (pre-quit) to 2 and 12 weeks post-TQD
Changes in anxiety
Time Frame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
Change in self-reported measures of anxiety, as measured by the GAD-7
Baseline (pre-quit) to 2 and 12 weeks post-TQD
Changes in depression
Time Frame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
Change in self-reported measures of depression, as measured by the PHQ-2
Baseline (pre-quit) to 2 and 12 weeks post-TQD
Changes in relapse predictors
Time Frame: Baseline (pre-quit) to 1 day post-TQD, 1 week post-TQD, 6 months post-TQD, and 12 months post-TQD
Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone
Baseline (pre-quit) to 1 day post-TQD, 1 week post-TQD, 6 months post-TQD, and 12 months post-TQD
Overall cost of treatment in dollars per participant
Time Frame: 12 weeks post-TQD
12 weeks post-TQD
cost of medical visits in dollars per abstinent participant
Time Frame: 12 weeks post-TQD
12 weeks post-TQD
cost of medications per abstinent smoker
Time Frame: 12 weeks post-TQD
12 weeks post-TQD
cost of behavioral intervention per abstinent smoker
Time Frame: 12 weeks post-TQD
12 weeks post-TQD
cost of prescribed medications in dollars
Time Frame: 12 weeks post-TQD
12 weeks post-TQD

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility: attendance records
Time Frame: up to 12 weeks post-TQD
Feasibility as measured by attendance and completion of HIT and MIT assessed by attendance records taken by instructors at individual classes or sessions
up to 12 weeks post-TQD
Feasibility: website usage
Time Frame: up to 12 weeks post-TQD
Feasibility as measured by website usage, as measured by electronically recorded login and site-based timer will record time accessing the site through each intervention
up to 12 weeks post-TQD
Feasibility: course evaluation
Time Frame: up to 12 weeks post-TQD
Feasibility as measured by course evaluation
up to 12 weeks post-TQD
Feasibility: demographics
Time Frame: Baseline
Feasibility as measured by demographics of patients at DSCP
Baseline
Feasibility: Medications Used
Time Frame: 12 weeks post-TQD
Feasibility as measured by medication use
12 weeks post-TQD
Feasibility: Behavioral intervention used
Time Frame: 12 weeks post-TQD
Feasibility as measured by behavioral intervention assignment
12 weeks post-TQD
Feasibility: Attendance at DSCP appointments
Time Frame: 12 weeks post-TQD
Feasibility as measured by attendance at DSCP appointments
12 weeks post-TQD
Feasibility: Referral routes to DSCP
Time Frame: Baseline
Feasibility as measured by referral routes to DSCP
Baseline
Feasibility: Side effects
Time Frame: 1 day post-TQD
Feasibility as measured by side effects, as measured by phone assessment
1 day post-TQD
Feasibility: Side effects
Time Frame: 1 week post-TQD
Feasibility as measured by side effects, as measured by phone assessment
1 week post-TQD
Feasibility: Side effects
Time Frame: 6 months post-TQD
Feasibility as measured by side effects, as measured by phone assessment
6 months post-TQD
Feasibility: Side effects
Time Frame: 12 months post-TQD
Feasibility as measured by side effects, as measured by phone assessment
12 months post-TQD
Feasibility: medication adherence
Time Frame: 1 day post-TQD
Feasibility as measured by medication adherence, as measured by phone assessment
1 day post-TQD
Feasibility: medication adherence
Time Frame: 1 week post-TQD
Feasibility as measured by medication adherence, as measured by phone assessment
1 week post-TQD
Feasibility: medication adherence
Time Frame: 6 months post-TQD
Feasibility as measured by medication adherence, as measured by phone assessment
6 months post-TQD
Feasibility: medication adherence
Time Frame: 12 months post-TQD
Feasibility as measured by medication adherence, as measured by phone assessment
12 months post-TQD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 16, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00073920
  • P50DA027840 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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