Motivating a Spectrum of Cancer Patients to Quit Smoking

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Cancer
• Intervention / Treatment: Behavioral: Self-help Materials

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self Help Materials; Participants will receive a smoking cessation booklet/pamphlet corresponding to their cancer type.	Behavioral: Self-help Materials; Self-help booklet targeted by cancer type to increase smoking cessation motivation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ursula Martinez, Ph.D., Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): April 13, 2022
• Study Completion (Actual): June 2, 2022

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MCC-19733; 1R03CA227044-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No