Motivating a Spectrum of Cancer Patients to Quit Smoking

April 3, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute

Motivating a Spectrum of Cancer Patients to Quit Smoking: Intervention Development and Feasibility

This study will assess feasibility and acceptability of an intervention designed to increase smoking cessation motivation among patients with a cancer not widely known to be smoking related.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
Interventional

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.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center

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

Description

Inclusion Criteria:

  • Smoking at least 1 cigarette in previous 30 days
  • Diagnosis of breast, colorectal, gynecological, skin melanoma, or bladder cancer within the last 6 months
  • Able to read/write English
  • Able to give informed consent
  • Not currently enrolled in a smoking cessation program

Exclusion Criteria:

  • Having distant metastases
  • Male patients with breast cancer

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Self Help Materials
Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type.
Behavioral: Self-help Materials
Self-help booklet targeted by cancer type to increase smoking cessation motivation

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
Number of Participants Who Consent to Participate in the Study- Feasibility
Time Frame: Baseline
Number of participants who consent to participate in the study
Baseline
Number of Participants That Complete 1-week Follow-up Assessments - Feasibility
Time Frame: 1-week post-treatment
Number of participants who complete 1-week follow-up assessments
1-week post-treatment
Number of Participants That Complete 1 Month Follow-up Assessments - Feasibility
Time Frame: 1-month post-treatment
Number of participants who complete 1-month follow-up assessments
1-month post-treatment
Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment
Time Frame: 1-week post-treatment
Number of study participants who read the booklet
1-week post-treatment
Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment
Time Frame: 1-month post-treatment
Number of study participants who read the booklet
1-month post-treatment
Acceptability
Time Frame: 1-month post-treatment
Treatment satisfaction measured with 8 items adapted from the Client Satisfaction Questionnaire, values between 8 and 32, with higher scores mean a better outcome.
1-month post-treatment

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
Motivation to Quit Smoking Assessed With the Contemplation Ladder
Time Frame: Baseline, 1-week post-treatment, 1-month post-treatment
Changes in motivation to quit smoking will be assessed using the Contemplation Ladder. This is a validated measure for the assessment of readiness to quit smoking on a scale from 0 to 10. Higher scores indicate greater motivation to quit smoking.
Baseline, 1-week post-treatment, 1-month post-treatment
Motivation to Quit Smoking Assessed With the Short Form of the Smoking Abstinence-related Motivational Engagement (ARME).
Time Frame: Baseline, 1-week post-treatment, 1-month post-treatment
Changes in motivation to quit smoking will be assessed using the short form of the smoking abstinence-related motivational engagement (ARME), which is a valid and reliable measure of cessation motivation that includes 5 items related to the smokers' daily experience with scores ranging from 5 to 35. Higher scores indicate greater motivation to quit smoking.
Baseline, 1-week post-treatment, 1-month post-treatment
Participants Change in Motivation - Action Stage
Time Frame: Baseline, at 1 week and 1 month post treatment
Changes in motivation to quit smoking will be assessed using the Stages of Change algorithm (SOC). This is a widely used measure for the assessment of readiness to quit smoking.
Baseline, at 1 week and 1 month post treatment
Motivation to Quit Smoking Assessed With the Number of Visits to the Study Website
Time Frame: 1-month post-treatment
A personal code will be able to track the number of participants who visited the study website where participants will find existing smoking cessation resources. This will be considered a behavioral indicator of motivation to quit smoking.
1-month post-treatment
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week
Time Frame: At 1 Week Post Treatment
Participants will be asked if they have contacted the tobacco treatment specialist or if they would like us to make a referral for them. This will be considered a behavioral indicator of motivation to quit smoking.
At 1 Week Post Treatment
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Month
Time Frame: At 1 Month Post Treatment
Participants will be asked if they have contacted the tobacco treatment specialist or if they would like us to make a referral for them. This will be considered a behavioral indicator of motivation to quit smoking.
At 1 Month Post Treatment
Participants That Had a Quit Attempt - 1 Week
Time Frame: At 1 Week Post Treatment
Number of participants that had a quit attempt that lasted at least 24 hours (at the 1-week assessment)
At 1 Week Post Treatment
Participants That Had a Quit Attempt - 1 Month
Time Frame: At 1 Month Post Treatment
Number of participants that had a quit attempt that lasted at least 24 hours
At 1 Month Post Treatment
Motivation to Quit Smoking Assessed With the Number of Quit Attempts - 1 Month
Time Frame: At 1 Month Post Treatment
Number of times participants quit smoking in the last 30 days (at the 1-month assessment).
At 1 Month Post Treatment
Number of Participants Reporting 7-day Point Prevalence Abstinence
Time Frame: 1-week post-treatment
Smoking abstinence will be determined by a self-report of not smoking in the last 7 days
1-week post-treatment
Number of Participants Reporting 30-day Point Prevalence Abstinence
Time Frame: 1-month post-treatment
Smoking abstinence will be determined by a self-report of not smoking in the last 30 days
1-month post-treatment

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.
H. Lee Moffitt Cancer Center and Research Institute

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 Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ursula Martinez, Ph.D., Moffitt Cancer Center

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.
June 14, 2021

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.
April 13, 2022

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.
June 2, 2022

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).
April 12, 2019

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.
June 3, 2021

First Posted (Actual)

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.
June 4, 2021

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.
April 25, 2023

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.
April 3, 2023

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.
February 1, 2023

More Information

Terms related to this study

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.
  • MCC-19733
  • 1R03CA227044-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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