Smoking CessationNCT02276664
Capitalizing on a Teachable Moment to Promote Smoking Cessation
A study testing Self-Help (SHI) in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Self-Help (SHI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2014to 21 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study 1
- Participants for Study I will be drawn from a list of patients who have received a CT scan at the Moffitt Cancer Center
- Smoked at least one cigarette per week prior to undergoing the CT scan
- Able to speak and read English
- Study 2
- Smoked at least one cigarette over the past week
- Able to read English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan.
Read the detailed description
Conduct Formative Research (Months 1 - 4): Identification of emergent themes and responses to existing booklets.
Adapt and Refine Booklets (Months 5 - 8): Advanced drafts of booklets.
Final Reactions to Draft Booklets (Months 9 - 12): Series of smoking cessation booklets for spiral computed tomography (CT) patients.
- Conditions
- Smoking Cessation
- Being tested
- Self-Help (SHI), Usual Care (UC)
- Keywords
- lung cancer prevention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Help (SHI)Behavioural
The newly revised Stop Smoking for Good booklets.
Usual Care (UC)Behavioural
The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).
| Study group | Role | What they receive |
|---|---|---|
| Study 1 - Focus Groups | No intervention | Using focus group methodology, investigators will identify and explore new content topics for inclusion in smoking cessation booklets and gather feedback about the existing Stop Smoking for Good booklets regarding tone and message design. Results will be used to modify and adapt the existing cessation intervention. |
| Study 2 - Self-Help Intervention (SHI) | Experimental | The SHI arm will receive the intervention developed in Study I. Receives: Behavioral: Self-Help (SHI) |
| Study 2 - Usual Care (UC) | Active comparator | The UC arm will receive the existing Clearing the Air smoking-cessation manual. Receives: Behavioral: Usual Care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1 - Completion of Formative Evaluation
Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.
Measured: Up to 12 months
Study 2 - Rate of Seven-Day Abstinence
Up to 9 months
Measured: Seven-day abstinence will be assessed at each follow-up, allowing for calculation of point-prevalence abstinence rates. For this pilot, we will not bioverify self-reported abstinence.
Secondary outcomes (2)
Rate of Intervention Demand
Demand will be estimated by noting accrual rates into the study.
Measured: Up to 9 months
Degree of Practicality
Practicality encompasses the degree to which investigators are able to carry out all the piloted elements of the planned randomized control trial (RCT) successfully and efficiently (i.e., recruitment, screening, randomization, and follow-up).
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study start20 Oct 2014
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Responsible party
- Sponsor
- Investigators
- Thomas Brandon, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276664
- Sponsor's protocol ID
- MCC-17952
- Other IDs
- 4KB05
- Status last verified
- Aug 2020
- First submitted
- 21 Oct 2014
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capitalizing on a Teachable Moment to Promote Smoking Cessation
- ClinicalTrials.gov ID
- NCT02276664
- Acronym / sponsor ID
- MCC-17952
- Conditions
- Smoking Cessation
- Keywords
- lung cancer prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- James and Esther King Biomedical Research Program
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan.
Detailed description
Conduct Formative Research (Months 1 - 4): Identification of emergent themes and responses to existing booklets.
Adapt and Refine Booklets (Months 5 - 8): Advanced drafts of booklets.
Final Reactions to Draft Booklets (Months 9 - 12): Series of smoking cessation booklets for spiral computed tomography (CT) patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study 1 - Focus Groups | No intervention | –Using focus group methodology, investigators will identify and explore new content topics for inclusion in smoking cessation booklets and gather feedback about the existing Stop Smoking for Good booklets regarding tone and message design. Results will be used to modify and adapt the existing cessation intervention. |
| Study 2 - Self-Help Intervention (SHI) | Experimental | Behavioral: Self-Help (SHI)The SHI arm will receive the intervention developed in Study I. |
| Study 2 - Usual Care (UC) | Active comparator | Behavioral: Usual Care (UC)The UC arm will receive the existing Clearing the Air smoking-cessation manual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Study 1
- Participants for Study I will be drawn from a list of patients who have received a CT scan at the Moffitt Cancer Center
- Smoked at least one cigarette per week prior to undergoing the CT scan
- Able to speak and read English
- Study 2
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Help (SHI)The newly revised Stop Smoking for Good booklets. | Behavioural | Study 2 - Self-Help Intervention (SHI) |
| Usual Care (UC)The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI). | Behavioural | Study 2 - Usual Care (UC) |
Primary outcome
Study 1 - Completion of Formative Evaluation
Time frame: Up to 12 months
Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.
Study 2 - Rate of Seven-Day Abstinence
Time frame: Seven-day abstinence will be assessed at each follow-up, allowing for calculation of point-prevalence abstinence rates. For this pilot, we will not bioverify self-reported abstinence.
Up to 9 months
2 secondary outcomes
Rate of Intervention Demand
Time frame: Up to 9 months
Degree of Practicality
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Brandon, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Help (SHI) in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1 - Completion of Formative Evaluation (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.