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

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03966807
Collaborator
(none)
60
2
48.4
30
0.6

Study Details

Study Description

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 Phase
  • Behavioral: Digital-based support
  • Behavioral: Traditional-based support + Nicotine replacement therapy (NRT)

Study Design

Study Type:
Observational
Anticipated 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
Actual Study Start Date :
Dec 19, 2019
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 7-day point prevalence of self -reported smoking cessation [4 weeks]

  2. 7-day point prevalence of self -reported smoking cessation [8 weeks]

  3. 7-day point prevalence of self -reported smoking cessation [12 weeks]

  4. 7-day point prevalence of self -reported smoking cessation [24 weeks]

  5. Willingness to quit [4 weeks]

  6. Willingness to quit [8 weeks]

  7. Willingness to quit [12 weeks]

  8. Willingness to quit [24 weeks]

  9. Preference for type of cessation intervention modality [4 weeks]

    digital versus traditional support with nicotine replacement therapy [NRT]

  10. Preference for type of cessation intervention modality [8 weeks]

    digital versus traditional support with nicotine replacement therapy [NRT]

  11. Preference for type of cessation intervention modality [12 weeks]

    digital versus traditional support with nicotine replacement therapy [NRT]

  12. Preference for type of cessation intervention modality [24 weeks]

    digital versus traditional support with nicotine replacement therapy [NRT]

Secondary Outcome Measures

  1. Mean change in readiness to quit [Baseline]

    Measured via the Readiness to Quit Ladder

  2. Mean change in readiness to quit [4 weeks]

    Measured via the Readiness to Quit Ladder

  3. Mean change in readiness to quit [8 weeks]

    Measured via the Readiness to Quit Ladder

  4. Mean change in readiness to quit [12 weeks]

    Measured via the Readiness to Quit Ladder

  5. Mean change in readiness to quit [24 weeks]

    Measured via the Readiness to Quit Ladder

  6. Mean change in nicotine dependence [Baseline]

    Measured via the Heaviness of Smoking Index

  7. Mean change in nicotine dependence [4 weeks]

    Measured via the Heaviness of Smoking Index

  8. Mean change in nicotine dependence [8 weeks]

    Measured via the Heaviness of Smoking Index

  9. Mean change in nicotine dependence [12 weeks]

    Measured via the Heaviness of Smoking Index

  10. Mean change in nicotine dependence [24 weeks]

    Measured via the Heaviness of Smoking Index

  11. Mean change in cigarette use [Baseline]

    Measured by by the self-reported number of cigarettes smoked per day

  12. Mean change in cigarette use [4 weeks]

    Measured by by the self-reported number of cigarettes smoked per day

  13. Mean change in cigarette use [8 weeks]

    Measured by by the self-reported number of cigarettes smoked per day

  14. Mean change in cigarette use [12 weeks]

    Measured by by the self-reported number of cigarettes smoked per day

  15. Mean change in cigarette use [24 weeks]

    Measured by by the self-reported number of cigarettes smoked per day

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IU Health Joe and Shelly Schwarz Cancer Center Carmel Indiana United States 46032
2 Indiana University Melvin & Bren Simon Cancer Center Indianapolis Indiana United States 46202

Sponsors and Collaborators

  • Indiana University

Investigators

  • Principal Investigator: Shadia Jalal, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shadia Jalal, Assistant Professor of Clinical Medicine, Indiana University
ClinicalTrials.gov Identifier:
NCT03966807
Other Study ID Numbers:
  • IUSCC-0670
First Posted:
May 29, 2019
Last Update Posted:
Oct 25, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shadia Jalal, Assistant Professor of Clinical Medicine, Indiana University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2021