Trial Outcomes & Findings for Motivating a Spectrum of Cancer Patients to Quit Smoking (NCT NCT04914000)

NCT ID: NCT04914000

Last Updated: 2023-04-25

Results Overview

Number of participants who consent to participate in the study

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-04-25

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	53
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	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
Overall Study Lost to Follow-up	8
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Motivating a Spectrum of Cancer Patients to Quit Smoking

Baseline characteristics by cohort

Measure	Self Help Materials n=53 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Number of participants who consent to participate in the study

Outcome measures

Measure	Self Help Materials n=53 Participants 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
Number of Participants Who Consent to Participate in the Study- Feasibility	53 Participants

PRIMARY outcome

Timeframe: 1-week post-treatment

Number of participants who complete 1-week follow-up assessments

Outcome measures

Measure	Self Help Materials n=48 Participants 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
Number of Participants That Complete 1-week Follow-up Assessments - Feasibility	46 Participants

PRIMARY outcome

Timeframe: 1-month post-treatment

Number of participants who complete 1-month follow-up assessments

Outcome measures

Measure	Self Help Materials n=48 Participants 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
Number of Participants That Complete 1 Month Follow-up Assessments - Feasibility	44 Participants

PRIMARY outcome

Timeframe: 1-week post-treatment

Number of study participants who read the booklet

Outcome measures

Measure	Self Help Materials n=46 Participants 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
Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment	38 Participants

PRIMARY outcome

Timeframe: 1-month post-treatment

Number of study participants who read the booklet

Outcome measures

Measure	Self Help Materials n=44 Participants 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
Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment	42 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Self Help Materials n=40 Participants 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
Acceptability	24.43 score on a scale Interval 8.0 to 32.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Self Help Materials n=48 Participants 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
Motivation to Quit Smoking Assessed With the Contemplation Ladder Basline	7.35 units on a scale Standard Deviation 2.22
Motivation to Quit Smoking Assessed With the Contemplation Ladder 1 week post treatment	7.58 units on a scale Standard Deviation 2.58
Motivation to Quit Smoking Assessed With the Contemplation Ladder 1 month post treatment	7.79 units on a scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Self Help Materials n=48 Participants 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
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
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
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 outcome

Timeframe: 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.

Outcome measures

Measure	Self Help Materials n=47 Participants 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
Participants Change in Motivation - Action Stage Baseline	4 Participants
Participants Change in Motivation - Action Stage 1 week post treatment	6 Participants
Participants Change in Motivation - Action Stage 1 month post treatment	12 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Self Help Materials n=48 Participants 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
Motivation to Quit Smoking Assessed With the Number of Visits to the Study Website	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Self Help Materials n=46 Participants 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
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week Contacted Smoking Cessation Program	2 Participants
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Week Requested a Referral	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Self Help Materials n=43 Participants 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
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Month Contacted Smoking Cessation Program	3 Participants
Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Month Requested a Referral	10 Participants

SECONDARY outcome

Timeframe: At 1 Week Post Treatment

Number of participants that had a quit attempt that lasted at least 24 hours (at the 1-week assessment)

Outcome measures

Measure	Self Help Materials n=46 Participants 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
Participants That Had a Quit Attempt - 1 Week	15 Participants

SECONDARY outcome

Timeframe: At 1 Month Post Treatment

Number of participants that had a quit attempt that lasted at least 24 hours

Outcome measures

Measure	Self Help Materials n=44 Participants 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
Participants That Had a Quit Attempt - 1 Month	25 Participants

SECONDARY outcome

Timeframe: At 1 Month Post Treatment

Number of times participants quit smoking in the last 30 days (at the 1-month assessment).

Outcome measures

Measure	Self Help Materials n=44 Participants 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
Motivation to Quit Smoking Assessed With the Number of Quit Attempts - 1 Month	6.74 Times participants quit smoking Standard Deviation 10.70

SECONDARY outcome

Timeframe: 1-week post-treatment

Smoking abstinence will be determined by a self-report of not smoking in the last 7 days

Outcome measures

Measure	Self Help Materials n=46 Participants 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
Number of Participants Reporting 7-day Point Prevalence Abstinence	6 Participants

SECONDARY outcome

Timeframe: 1-month post-treatment

Smoking abstinence will be determined by a self-report of not smoking in the last 30 days

Outcome measures

Measure	Self Help Materials n=44 Participants 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
Number of Participants Reporting 30-day Point Prevalence Abstinence	12 Participants

Adverse Events

Self Help Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ursula Martinez

Moffitt Cancer Center

Phone: 813-745-1754

Email: Ursula.Martinez@moffitt.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place