Clinical trial NCT03966807: Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting for Actively Smoking Family Members
Official title: Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting as a Potential Teachable Moment for Actively Smoking Family Members
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: lung cancer
caregiver
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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..


Eligibility criteria: 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

Primary outcomes:
measure: 7-day point prevalence of self -reported smoking cessation
timeFrame: 4 weeks
measure: 7-day point prevalence of self -reported smoking cessation
timeFrame: 8 weeks
measure: 7-day point prevalence of self -reported smoking cessation
timeFrame: 12 weeks
measure: 7-day point prevalence of self -reported smoking cessation
timeFrame: 24 weeks
measure: Willingness to quit
timeFrame: 4 weeks
measure: Willingness to quit
timeFrame: 8 weeks
measure: Willingness to quit
timeFrame: 12 weeks
measure: Willingness to quit
timeFrame: 24 weeks
measure: Preference for type of cessation intervention modality
timeFrame: 4 weeks
measure: Preference for type of cessation intervention modality
timeFrame: 8 weeks
measure: Preference for type of cessation intervention modality
timeFrame: 12 weeks
measure: Preference for type of cessation intervention modality
timeFrame: 24 weeks
Secondary outcomes:
measure: Mean change in readiness to quit
timeFrame: Baseline
measure: Mean change in readiness to quit
timeFrame: 4 weeks
measure: Mean change in readiness to quit
timeFrame: 8 weeks
measure: Mean change in readiness to quit
timeFrame: 12 weeks
measure: Mean change in readiness to quit
timeFrame: 24 weeks
measure: Mean change in nicotine dependence
timeFrame: Baseline
measure: Mean change in nicotine dependence
timeFrame: 4 weeks
measure: Mean change in nicotine dependence
timeFrame: 8 weeks
measure: Mean change in nicotine dependence
timeFrame: 12 weeks
measure: Mean change in nicotine dependence
timeFrame: 24 weeks
measure: Mean change in cigarette use
timeFrame: Baseline
measure: Mean change in cigarette use
timeFrame: 4 weeks
measure: Mean change in cigarette use
timeFrame: 8 weeks
measure: Mean change in cigarette use
timeFrame: 12 weeks
measure: Mean change in cigarette use
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Shadia Jalal, MD
role: PRINCIPAL_INVESTIGATOR
References: