Motivating a Spectrum of Cancer Patients to Quit Smoking

Cancer Clinical Trial

Official title:

Motivating a Spectrum of Cancer Patients to Quit Smoking: Intervention Development and Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914000
• Other study ID #: MCC-19733
• Secondary ID: 1R03CA227044-01A
• Status: Completed
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: June 2, 2022

Study information

• Verified date: February 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Smoking

Intervention

Behavioral:
• Self-help Materials
Self-help booklet targeted by cancer type to increase smoking cessation motivation

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Consent to Participate in the Study- Feasibility	Number of participants who consent to participate in the study	Baseline
Primary	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
Primary	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
Primary	Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment	Number of study participants who read the booklet	1-week post-treatment
Primary	Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment	Number of study participants who read the booklet	1-month post-treatment
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.	1-month post-treatment
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.	Baseline, 1-week post-treatment, 1-month post-treatment
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.	Baseline, 1-week post-treatment, 1-month post-treatment
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.	Baseline, at 1 week and 1 month post treatment
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.	1-month post-treatment
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.	At 1 Week Post Treatment
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.	At 1 Month Post Treatment
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)	At 1 Week Post Treatment
Secondary	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
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).	At 1 Month Post Treatment
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	1-week post-treatment
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	1-month post-treatment