Motivating a Spectrum of Cancer Patients to Quit Smoking

Not Applicable

Completed

• Conditions: Cancer; Smoking
• Interventions: Behavioral: Self-help Materials

• Registration Number: NCT04914000
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-04
• Study Start: 2021-06-14
• Primary Completion: 2022-04-13
• Study Completion: 2022-06-02
• Status Verified: 2023-02
• Results First Submitted: 2023-02-27
• Results First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Results First Posted: 2023-04-25
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Self Help Materials	Self-help Materials	Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type.

Primary Outcome Measures

Name	Time	Method
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
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 Consent to Participate in the Study- Feasibility	Baseline	Number of participants who consent to participate in the study
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 Outcome Measures

Name	Time	Method
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.
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 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.
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.
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 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.
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 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 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.
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)

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States