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

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

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..

Study Overview

• Status: Terminated
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Digital-based support; Behavioral: Traditional-based support + Nicotine replacement therapy (NRT)

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin & Bren Simon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed lung cancers will be identified from the daily patient lists at the thoracic oncology clinics at IUSCC, Roudebush VAMC, and Eskenazi. The study coordinator will screen for newly diagnosed lung cancer patients to identify potential family member/caregiver study participants.

Patients will be approached and asked whether they have any family members/caregivers who smoke, and if they would be willing to allow the study team to contact those people (or person) with information about the study. For patients who agree and have family members/caregivers present at the clinic visit that day, the study coordinator (or other designated member of the study team) will discuss the purpose of the study and utilize the 5A strategy (Ask, Advice, Assess willingness to quit, Assist, Arrange follow-up) to ascertain interest in participation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
7-day point prevalence of self -reported smoking cessation		4 weeks
7-day point prevalence of self -reported smoking cessation		8 weeks
7-day point prevalence of self -reported smoking cessation		12 weeks
7-day point prevalence of self -reported smoking cessation		24 weeks
Willingness to quit		4 weeks
Willingness to quit		8 weeks
Willingness to quit		12 weeks
Willingness to quit		24 weeks
Preference for type of cessation intervention modality	digital versus traditional support with nicotine replacement therapy [NRT]	4 weeks
Preference for type of cessation intervention modality	digital versus traditional support with nicotine replacement therapy [NRT]	8 weeks
Preference for type of cessation intervention modality	digital versus traditional support with nicotine replacement therapy [NRT]	12 weeks
Preference for type of cessation intervention modality	digital versus traditional support with nicotine replacement therapy [NRT]	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	Baseline
Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	4 weeks
Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	8 weeks
Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	12 weeks
Mean change in readiness to quit	Measured via the Readiness to Quit Ladder	24 weeks
Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	Baseline
Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	4 weeks
Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	8 weeks
Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	12 weeks
Mean change in nicotine dependence	Measured via the Heaviness of Smoking Index	24 weeks
Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	Baseline
Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	4 weeks
Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	8 weeks
Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	12 weeks
Mean change in cigarette use	Measured by by the self-reported number of cigarettes smoked per day	24 weeks

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Shadia Jalal, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): March 29, 2022
• Study Completion (Actual): March 29, 2022

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: lung cancer; caregiver
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: IUSCC-0670

Drug and device information, study documents

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