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Completed

NCT Number: NCT04914000

Motivating a Spectrum of Cancer Patients to Quit Smoking

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.

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Key information

Conditions

Cancer Behavior Neoplasms Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-help materials

Behavioral

Self-help booklet targeted by cancer type to increase smoking cessation motivation

Primary outcomes

  1. Number of Participants Who Consent to Participate in the Study- Feasibility

    Time frame: Baseline

    Number of participants who consent to participate in the study

  2. Number of Participants That Complete 1-week Follow-up Assessments - Feasibility

    Time frame: 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

    Time frame: 1-month post-treatment

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

  4. Number of Participants Who Read the Booklet - Demand - 1 Week Post Treatment

    Time frame: 1-week post-treatment

    Number of study participants who read the booklet

  5. Number of Participants Who Read the Booklet - Demand - 1 Month Post Treatment

    Time frame: 1-month post-treatment

    Number of study participants who read the booklet

  6. Acceptability

    Time frame: 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 outcomes

  1. Motivation to Quit Smoking Assessed With the Contemplation Ladder

    Time frame: 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).

    Time frame: 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.

  3. Participants Change in Motivation - Action Stage

    Time frame: 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.

  4. Motivation to Quit Smoking Assessed With the Number of Visits to the Study Website

    Time frame: 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

    Time frame: 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.

  6. Motivation to Quit Smoking Assessed by Contact With the Tobacco Treatment Specialist - 1 Month

    Time frame: 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.

  7. Participants That Had a Quit Attempt - 1 Week

    Time frame: At 1 Week Post Treatment

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

  8. Participants That Had a Quit Attempt - 1 Month

    Time frame: At 1 Month Post Treatment

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

  9. Motivation to Quit Smoking Assessed With the Number of Quit Attempts - 1 Month

    Time frame: At 1 Month Post Treatment

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

  10. Number of Participants Reporting 7-day Point Prevalence Abstinence

    Time frame: 1-week post-treatment

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

  11. Number of Participants Reporting 30-day Point Prevalence Abstinence

    Time frame: 1-month post-treatment

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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2021
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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