Cancer, Smoking
Conditions
Brief 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.
Interventions
BEHAVIORALSelf-help Materials
Self-help booklet targeted by cancer type to increase smoking cessation motivation
Sponsors
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Consent to Participate in the Study- Feasibility | Baseline | Number of participants who consent to participate in the study |
| Number of Participants That Complete 1-week Follow-up Assessments - Feasibility | 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 | 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 | 1-week post-treatment | Number of study participants who read the booklet |
| Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment | 1-month post-treatment | Number of study participants who read the booklet |
| Acceptability | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants That Had a Quit Attempt - 1 Week | At 1 Week Post Treatment | Number of participants that had a quit attempt that lasted at least 24 hours (at the 1-week assessment) |
| Participants That Had a Quit Attempt - 1 Month | At 1 Month Post Treatment | Number of participants that had a quit attempt that lasted at least 24 hours |
| Motivation to Quit Smoking Assessed With the Contemplation Ladder | 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. |
| Number of Participants Reporting 7-day Point Prevalence Abstinence | 1-week post-treatment | Smoking abstinence will be determined by a self-report of not smoking in the last 7 days |
| Number of Participants Reporting 30-day Point Prevalence Abstinence | 1-month post-treatment | Smoking abstinence will be determined by a self-report of not smoking in the last 30 days |
| Motivation to Quit Smoking Assessed With the Number of Quit Attempts - 1 Month | At 1 Month Post Treatment | Number of times participants quit smoking in the last 30 days (at the 1-month assessment). |
| Motivation to Quit Smoking Assessed With the Short Form of the Smoking Abstinence-related Motivational Engagement (ARME). | 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. |
| Participants Change in Motivation - Action Stage | 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. |
| Motivation to Quit Smoking Assessed With the Number of Visits to the Study Website | 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. |
| Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week | 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. |
| Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Month | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Self Help Materials |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 53 Participants |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 1-month post-treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Self Help Materials | Acceptability | 24.43 score on a scale |
Primary
Number of Participants That Complete 1 Month Follow-up Assessments - Feasibility
Number of participants who complete 1-month follow-up assessments
Time frame: 1-month post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Number of Participants That Complete 1 Month Follow-up Assessments - Feasibility | 44 Participants |
Primary
Number of Participants That Complete 1-week Follow-up Assessments - Feasibility
Number of participants who complete 1-week follow-up assessments
Time frame: 1-week post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Number of Participants That Complete 1-week Follow-up Assessments - Feasibility | 46 Participants |
Primary
Number of Participants Who Consent to Participate in the Study- Feasibility
Number of participants who consent to participate in the study
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Number of Participants Who Consent to Participate in the Study- Feasibility | 53 Participants |
Primary
Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment
Number of study participants who read the booklet
Time frame: 1-month post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment | 42 Participants |
Primary
Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment
Number of study participants who read the booklet
Time frame: 1-week post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment | 38 Participants |
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.
Time frame: At 1 Month Post Treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self Help Materials | Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Month | Contacted Smoking Cessation Program | 3 Participants |
| Self Help Materials | Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Month | Requested a Referral | 10 Participants |
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.
Time frame: At 1 Week Post Treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self Help Materials | Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week | Contacted Smoking Cessation Program | 2 Participants |
| Self Help Materials | Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week | Requested a Referral | 10 Participants |
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.
Time frame: Baseline, 1-week post-treatment, 1-month post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self Help Materials | Motivation to Quit Smoking Assessed With the Contemplation Ladder | Basline | 7.35 units on a scale | Standard Deviation 2.22 |
| Self Help Materials | Motivation to Quit Smoking Assessed With the Contemplation Ladder | 1 week post treatment | 7.58 units on a scale | Standard Deviation 2.58 |
| Self Help Materials | Motivation to Quit Smoking Assessed With the Contemplation Ladder | 1 month post treatment | 7.79 units on a scale | Standard Deviation 2.41 |
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).
Time frame: At 1 Month Post Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Help Materials | Motivation to Quit Smoking Assessed With the Number of Quit Attempts - 1 Month | 6.74 Times participants quit smoking | Standard Deviation 10.7 |
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.
Time frame: 1-month post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Motivation to Quit Smoking Assessed With the Number of Visits to the Study Website | 1 Participants |
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.
Time frame: Baseline, 1-week post-treatment, 1-month post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self Help Materials | Motivation to Quit Smoking Assessed With the Short Form of the Smoking Abstinence-related Motivational Engagement (ARME). | Baseline | 23.41 score on a scale | Standard Deviation 7.77 |
| Self Help Materials | Motivation to Quit Smoking Assessed With the Short Form of the Smoking Abstinence-related Motivational Engagement (ARME). | 1 Week Post Treatment | 24.59 score on a scale | Standard Deviation 8.05 |
| Self Help Materials | Motivation to Quit Smoking Assessed With the Short Form of the Smoking Abstinence-related Motivational Engagement (ARME). | 1 Month Post Treatment | 24.11 score on a scale | Standard Deviation 7.96 |
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
Time frame: 1-month post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Number of Participants Reporting 30-day Point Prevalence Abstinence | 12 Participants |
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
Time frame: 1-week post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Number of Participants Reporting 7-day Point Prevalence Abstinence | 6 Participants |
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.
Time frame: Baseline, at 1 week and 1 month post treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self Help Materials | Participants Change in Motivation - Action Stage | Baseline | 4 Participants |
| Self Help Materials | Participants Change in Motivation - Action Stage | 1 week post treatment | 6 Participants |
| Self Help Materials | Participants Change in Motivation - Action Stage | 1 month post treatment | 12 Participants |
Secondary
Participants That Had a Quit Attempt - 1 Month
Number of participants that had a quit attempt that lasted at least 24 hours
Time frame: At 1 Month Post Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Participants That Had a Quit Attempt - 1 Month | 25 Participants |
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)
Time frame: At 1 Week Post Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Self Help Materials | Participants That Had a Quit Attempt - 1 Week | 15 Participants |