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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03CA227044-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self Help Materials | Experimental | Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-help Materials | Behavioral | Self-help booklet targeted by cancer type to increase smoking cessation motivation |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Consent to Participate in the Study- Feasibility | Number of participants who consent to participate in the study | Baseline |
| Number of Participants That Complete 1-week Follow-up Assessments - Feasibility | 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 | 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 | Number of study participants who read the booklet | 1-week post-treatment |
| Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment | Number of study participants who read the booklet | 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. | 1-month post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1-week post-treatment, 1-month post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ursula Martinez, Ph.D. | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Self Help Materials | Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type. Self-help Materials: Self-help booklet targeted by cancer type to increase smoking cessation motivation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Self Help Materials | Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type. Self-help Materials: Self-help booklet targeted by cancer type to increase smoking cessation motivation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Consent to Participate in the Study- Feasibility | Number of participants who consent to participate in the study | Posted | Count of Participants | Participants | Baseline |
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Adverse Events were not collected
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Self Help Materials | Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type. Self-help Materials: Self-help booklet targeted by cancer type to increase smoking cessation motivation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ursula Martinez | Moffitt Cancer Center | 813-745-1754 | Ursula.Martinez@moffitt.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2021 | Feb 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2021 | Feb 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| 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. | 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. | 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. | 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. | 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. | 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) | 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 | 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). | 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 | 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 | 1-month post-treatment |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Number of Participants That Complete 1-week Follow-up Assessments - Feasibility | Number of participants who complete 1-week follow-up assessments | Posted | Count of Participants | Participants | 1-week post-treatment |
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| Primary | Number of Participants That Complete 1 Month Follow-up Assessments - Feasibility | Number of participants who complete 1-month follow-up assessments | Posted | Count of Participants | Participants | 1-month post-treatment |
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| Primary | Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment | Number of study participants who read the booklet | Posted | Count of Participants | Participants | 1-week post-treatment |
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| Primary | Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment | Number of study participants who read the booklet | Posted | Count of Participants | Participants | 1-month post-treatment |
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| Primary | 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. | Posted | Mean | Full Range | score on a scale | 1-month post-treatment |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1-week post-treatment, 1-month post-treatment |
|
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|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1-week post-treatment, 1-month post-treatment |
|
|
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| Secondary | 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. | Posted | Count of Participants | Participants | Baseline, at 1 week and 1 month post treatment |
|
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| Secondary | 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. | Posted | Count of Participants | Participants | 1-month post-treatment |
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| Secondary | 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. | Posted | Count of Participants | Participants | At 1 Week Post Treatment |
|
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| Secondary | 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. | Posted | Count of Participants | Participants | At 1 Month Post Treatment |
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| Secondary | 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) | Posted | Count of Participants | Participants | At 1 Week Post Treatment |
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| Secondary | Participants That Had a Quit Attempt - 1 Month | Number of participants that had a quit attempt that lasted at least 24 hours | Posted | Count of Participants | Participants | At 1 Month Post Treatment |
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| Secondary | 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). | Posted | Mean | Standard Deviation | Times participants quit smoking | At 1 Month Post Treatment |
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| Secondary | 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 | Posted | Count of Participants | Participants | 1-week post-treatment |
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| Secondary | 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 | Posted | Count of Participants | Participants | 1-month post-treatment |
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