CancerNCT04914000
Motivating a Spectrum of Cancer Patients to Quit Smoking
A study testing Self-help Materials in people with Cancer and Smoking, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Self-help Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having distant metastases
- Male patients with breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Self-help Materials
- Medical subject headings
- Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help MaterialsBehavioural
Self-help booklet targeted by cancer type to increase smoking cessation motivation
| Study group | Role | What they receive |
|---|---|---|
| Self Help Materials | Experimental | Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type. Receives: Behavioral: Self-help Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Consent to Participate in the Study- Feasibility
Number of participants who consent to participate in the study
Measured: Baseline
Number of Participants That Complete 1-week Follow-up Assessments - Feasibility
Number of participants who complete 1-week follow-up assessments
Measured: 1-week post-treatment
Number of Participants That Complete 1 Month Follow-up Assessments - Feasibility
Number of participants who complete 1-month follow-up assessments
Measured: 1-month post-treatment
Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment
Number of study participants who read the booklet
Measured: 1-week post-treatment
Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment
Number of study participants who read the booklet
Measured: 1-month post-treatment
Acceptability
Treatment satisfaction measured with 8 items adapted from the Client Satisfaction Questionnaire, values between 8 and 32, with higher scores mean a better outcome.
Measured: 1-month post-treatment
Secondary outcomes (11)
Motivation to Quit Smoking Assessed With the Contemplation Ladder
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.
Measured: 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).
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.
Measured: Baseline, 1-week post-treatment, 1-month post-treatment
Participants Change in Motivation - Action Stage
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.
Measured: Baseline, at 1 week and 1 month post treatment
Motivation to Quit Smoking Assessed With the Number of Visits to the Study Website
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.
Measured: 1-month post-treatment
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week
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.
Measured: At 1 Week Post Treatment
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Month
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.
Measured: At 1 Month Post Treatment
Participants That Had a Quit Attempt - 1 Week
Number of participants that had a quit attempt that lasted at least 24 hours (at the 1-week assessment)
Measured: At 1 Week Post Treatment
Participants That Had a Quit Attempt - 1 Month
Number of participants that had a quit attempt that lasted at least 24 hours
Measured: At 1 Month Post Treatment
Motivation to Quit Smoking Assessed With the Number of Quit Attempts - 1 Month
Number of times participants quit smoking in the last 30 days (at the 1-month assessment).
Measured: At 1 Month Post Treatment
Number of Participants Reporting 7-day Point Prevalence Abstinence
Smoking abstinence will be determined by a self-report of not smoking in the last 7 days
Measured: 1-week post-treatment
Number of Participants Reporting 30-day Point Prevalence Abstinence
Smoking abstinence will be determined by a self-report of not smoking in the last 30 days
Measured: 1-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start14 Jun 2021
- Primary completion13 Apr 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ursula Martinez, Ph.D., Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914000
- Sponsor's protocol ID
- MCC-19733
- Other IDs
- 1R03CA227044-01A1
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2019
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating a Spectrum of Cancer Patients to Quit Smoking: Intervention Development and Feasibility
- ClinicalTrials.gov ID
- NCT04914000
- Acronym / sponsor ID
- MCC-19733
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Posted 25 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self Help Materials | Experimental | Behavioral: Self-help MaterialsParticipants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Having distant metastases
- Male patients with breast cancer
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 MaterialsSelf-help booklet targeted by cancer type to increase smoking cessation motivation | Behavioural | Self Help Materials |
Primary outcome
Number of Participants Who Consent to Participate in the Study- Feasibility
Time frame: Baseline
Number of participants who consent to participate in the study
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
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
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
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
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.
11 secondary outcomes
Motivation to Quit Smoking Assessed With the Contemplation Ladder
Time frame: 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
Participants Change in Motivation - Action Stage
Time frame: 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
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week
Time frame: 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 That Had a Quit Attempt - 1 Week
Time frame: At 1 Week Post Treatment
Participants That Had a Quit Attempt - 1 Month
Time frame: 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 Participants Reporting 7-day Point Prevalence Abstinence
Time frame: 1-week post-treatment
Number of Participants Reporting 30-day Point Prevalence Abstinence
Time frame: 1-month post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ursula Martinez, Ph.D. principal investigator
Moffitt Cancer Center
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 Materials in people with Cancer and Smoking, 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 5 inclusion and 2 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 25 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Consent to Participate in the Study- Feasibility (time frame: Baseline). The study lists 6 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 25 Apr 2023.