Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting for Actively Smoking Family Members

Lung Cancer Clinical Trial

Official title:

Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting as a Potential Teachable Moment for Actively Smoking Family Members

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03966807
• Other study ID #: IUSCC-0670
• Status: Terminated
• Start date: September 13, 2021
• Est. completion date: March 29, 2022

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this pilot study is to examine, in an innovative setting, the potential for a lung cancer diagnosis in a loved one to represent a teachable moment for smoking cessation in family members or caregivers who are current smokers. The researchers will identify the willingness and preferred modality for smoking cessation among family members/caregivers in this setting. The researchers will estimate abstinence rates at 4, 8, 12, and 24 weeks..

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 29, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria:

1. patient with newly diagnosed lung cancer within the last 6 months of initial diagnosis/confirmation of diagnosis at the study sites

2. Able to provide informed consent

3. Able to speak and read English

Family Member/Caregiver Participant Criteria:

1. Family member or caregiver (defined as first degree relative [parent, sibling, child] or person living in the same household)

2. Family member or caregiver must be a current, active smoker (defined as 10 cigarettes per day for 6 consecutive months).

3. At least 18 years of age at time of study consent

4. Able to provide informed consent

5. Able to speak and read English

Exclusion Criteria:

1. Currently receiving formal tobacco dependence treatment- Nicotine replacement of any kind, varenicycline or Bupropion.

2. Medical condition that precludes proposed pharmacotherapy for smoking cessation :

Recent (= 2 weeks) myocardial infarction , history of underlying arrhythmias , history of serious or worsening angina pectoris, pregnancy and breastfeeding

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Digital-based support
Digital support will consist of referral for the participant to visit https://smokefree.gov, a website which offers a menu of internet- and text-based support options.
• Traditional-based support + Nicotine replacement therapy (NRT)
Traditional support will consist of participant referral to the Indiana Tobacco Quitline (1-800-QUIT-NOW) which is a telephone hotline that connects participants to Indiana smoking cessation resources.

Locations

Country	Name	City	State
United States	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day point prevalence of self -reported smoking cessation		4 weeks
Primary	7-day point prevalence of self -reported smoking cessation		8 weeks
Primary	7-day point prevalence of self -reported smoking cessation		12 weeks
Primary	7-day point prevalence of self -reported smoking cessation		24 weeks
Primary	Willingness to quit		4 weeks
Primary	Willingness to quit		8 weeks
Primary	Willingness to quit		12 weeks
Primary	Willingness to quit		24 weeks
Primary	Preference for type of cessation intervention modality	digital versus traditional support with nicotine replacement therapy [NRT]	4 weeks
Primary	Preference for type of cessation intervention modality	digital versus traditional support with nicotine replacement therapy [NRT]	8 weeks
Primary	Preference for type of cessation intervention modality	digital versus traditional support with nicotine replacement therapy [NRT]	12 weeks
Primary	Preference for type of cessation intervention modality	digital versus traditional support with nicotine replacement therapy [NRT]	24 weeks
Secondary	Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	Baseline
Secondary	Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	4 weeks
Secondary	Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	8 weeks
Secondary	Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	12 weeks
Secondary	Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	24 weeks
Secondary	Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	Baseline
Secondary	Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	4 weeks
Secondary	Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	8 weeks
Secondary	Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	12 weeks
Secondary	Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	24 weeks
Secondary	Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	Baseline
Secondary	Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	4 weeks
Secondary	Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	8 weeks
Secondary	Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	12 weeks
Secondary	Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	24 weeks