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

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ClinicalTrials.gov Identifier: NCT03966807
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Shadia Jalal, Indiana University

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..

Condition or disease Intervention/treatment
Lung Cancer Behavioral: Digital-based support Behavioral: Traditional-based support + Nicotine replacement therapy (NRT)

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting as a Potential Teachable Moment for Actively Smoking Family Members
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer Smoking

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.




Primary Outcome Measures :
  1. 7-day point prevalence of self -reported smoking cessation [ Time Frame: 4 weeks ]
  2. 7-day point prevalence of self -reported smoking cessation [ Time Frame: 8 weeks ]
  3. 7-day point prevalence of self -reported smoking cessation [ Time Frame: 12 weeks ]
  4. 7-day point prevalence of self -reported smoking cessation [ Time Frame: 24 weeks ]
  5. Willingness to quit [ Time Frame: 4 weeks ]
  6. Willingness to quit [ Time Frame: 8 weeks ]
  7. Willingness to quit [ Time Frame: 12 weeks ]
  8. Willingness to quit [ Time Frame: 24 weeks ]
  9. Preference for type of cessation intervention modality [ Time Frame: 4 weeks ]
    digital versus traditional support with nicotine replacement therapy [NRT]

  10. Preference for type of cessation intervention modality [ Time Frame: 8 weeks ]
    digital versus traditional support with nicotine replacement therapy [NRT]

  11. Preference for type of cessation intervention modality [ Time Frame: 12 weeks ]
    digital versus traditional support with nicotine replacement therapy [NRT]

  12. Preference for type of cessation intervention modality [ Time Frame: 24 weeks ]
    digital versus traditional support with nicotine replacement therapy [NRT]


Secondary Outcome Measures :
  1. Mean change in readiness to quit [ Time Frame: Baseline ]
    Measured via the Readiness to Quit Ladder

  2. Mean change in readiness to quit [ Time Frame: 4 weeks ]
    Measured via the Readiness to Quit Ladder

  3. Mean change in readiness to quit [ Time Frame: 8 weeks ]
    Measured via the Readiness to Quit Ladder

  4. Mean change in readiness to quit [ Time Frame: 12 weeks ]
    Measured via the Readiness to Quit Ladder

  5. Mean change in readiness to quit [ Time Frame: 24 weeks ]
    Measured via the Readiness to Quit Ladder

  6. Mean change in nicotine dependence [ Time Frame: Baseline ]
    Measured via the Heaviness of Smoking Index

  7. Mean change in nicotine dependence [ Time Frame: 4 weeks ]
    Measured via the Heaviness of Smoking Index

  8. Mean change in nicotine dependence [ Time Frame: 8 weeks ]
    Measured via the Heaviness of Smoking Index

  9. Mean change in nicotine dependence [ Time Frame: 12 weeks ]
    Measured via the Heaviness of Smoking Index

  10. Mean change in nicotine dependence [ Time Frame: 24 weeks ]
    Measured via the Heaviness of Smoking Index

  11. Mean change in cigarette use [ Time Frame: Baseline ]
    Measured by by the self-reported number of cigarettes smoked per day

  12. Mean change in cigarette use [ Time Frame: 4 weeks ]
    Measured by by the self-reported number of cigarettes smoked per day

  13. Mean change in cigarette use [ Time Frame: 8 weeks ]
    Measured by by the self-reported number of cigarettes smoked per day

  14. Mean change in cigarette use [ Time Frame: 12 weeks ]
    Measured by by the self-reported number of cigarettes smoked per day

  15. Mean change in cigarette use [ Time Frame: 24 weeks ]
    Measured by by the self-reported number of cigarettes smoked per day



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Criteria

Inclusion Criteria:

  1. Family member or caregiver (defined as first degree relative [parent, sibling, child] or person living in the same household) of patient with newly diagnosed lung cancer (within the last 3 months of initial diagnosis/confirmation of diagnosis at the study sites)
  2. Family member or caregiver must be a current, active smoker (defined as 10 cigarettes per day for 6 consecutive months).
  3. 18-65 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966807


Locations
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United States, Indiana
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Shadia Jalal, MD Indiana University

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Responsible Party: Shadia Jalal, Assistant Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT03966807     History of Changes
Other Study ID Numbers: IUSCC-0670
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shadia Jalal, Indiana University:
lung cancer
caregiver
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action