Motivating a Spectrum of Cancer Patients to Quit Smoking

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04914000
Collaborator
National Cancer Institute (NCI) (NIH)
50
Enrollment
1
Location
1
Arm
12.6
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Self-help Materials
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Motivating a Spectrum of Cancer Patients to Quit Smoking: Intervention Development and Feasibility
Actual Study Start Date :
Jun 14, 2021
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Number of participants who consent to participate in the study- Feasibility [Baseline]

    Number of participants who consent to participate in the study

  2. 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

  3. 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

  4. Demand - 1 Week Post Treatment [1-week post-treatment]

    Number of study participants who read the booklet

  5. Demand - 1 Month Post Treatment [1-month post-treatment]

    Number of study participants who read the booklet

  6. Acceptability [1-month post-treatment]

    Treatment satisfaction measured with 8 items adapted from the Client Satisfaction Questionnaire

Secondary Outcome Measures

  1. 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.

  2. 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 ranging from 1 (completely disagree) to 7 (completely agree). Higher scores indicate greater motivation to quit smoking.

  3. Motivation to quit smoking assessed with the Stages of Change Algorithm (SOC) [Baseline, 1-week post-treatment, 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.

  4. 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.

  5. Motivation to quit smoking assessed by contact with the tobacco treatment specialist [1-week post-treatment, 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.

  6. Motivation to quit smoking assessed with the number of quit attempts [1-week post-treatment, 1-month post-treatment]

    One item will assessed if participants had a quit attempt that lasted at least 24 hours (at the 1-week assessment) and how many times participants quit smoking in the last 30 days (at the 1-month assessment).

  7. Motivation to quit smoking assessed with the number of quit attempts at 1 week [1-week post-treatment]

    Number of participants that had a quit attempt that lasted at least 24 hours at the 1-week assessment and how many times participants quit smoking in the last 30 days (at the 1-month assessment).

  8. Motivation to quit smoking assessed with the number times participants quit smoking [1-month post-treatment]

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

  9. Biochemically confirmed 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 and by a result of ≤5ppm in carbon monoxide breath testing.

  10. Biochemically confirmed 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 and by a result of ≤5ppm in carbon monoxide breath testing.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Moffitt Cancer CenterTampaFloridaUnited States33612

Sponsors and Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ursula Martinez, Ph.D., Moffitt Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT04914000
Other Study ID Numbers:
  • MCC-19733
  • 1R03CA227044-01A1
First Posted:
Jun 4, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 16, 2021