Lung CancerNCT03966807
Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting for Actively Smoking Family Members
An observational study of Lung Cancer, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Digital-based support and Traditional-based support + Nicotine replacement therapy (NRT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2021to 29 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Currently receiving formal tobacco dependence treatment- Nicotine replacement of any kind, varenicycline or Bupropion.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: 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..
- Conditions
- Lung Cancer
- Being tested
- Digital-based support, Traditional-based support + Nicotine replacement therapy (NRT)
- Keywords
- lung cancer, caregiver
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital-based supportBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital-based support | |
| 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. Receives: Behavioral: Traditional-based support + Nicotine replacement therapy (NRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence of self -reported smoking cessation
Measured: 4 weeks
7-day point prevalence of self -reported smoking cessation
Measured: 8 weeks
7-day point prevalence of self -reported smoking cessation
Measured: 12 weeks
7-day point prevalence of self -reported smoking cessation
Measured: 24 weeks
Willingness to quit
Measured: 4 weeks
Willingness to quit
Measured: 8 weeks
Willingness to quit
Measured: 12 weeks
Willingness to quit
Measured: 24 weeks
Preference for type of cessation intervention modality
digital versus traditional support with nicotine replacement therapy [NRT]
Measured: 4 weeks
Preference for type of cessation intervention modality
digital versus traditional support with nicotine replacement therapy [NRT]
Measured: 8 weeks
Preference for type of cessation intervention modality
digital versus traditional support with nicotine replacement therapy [NRT]
Measured: 12 weeks
Preference for type of cessation intervention modality
digital versus traditional support with nicotine replacement therapy [NRT]
Measured: 24 weeks
Secondary outcomes (15)
Mean change in readiness to quit
Measured via the Readiness to Quit Ladder
Measured: Baseline
Mean change in readiness to quit
Measured via the Readiness to Quit Ladder
Measured: 4 weeks
Mean change in readiness to quit
Measured via the Readiness to Quit Ladder
Measured: 8 weeks
Mean change in readiness to quit
Measured via the Readiness to Quit Ladder
Measured: 12 weeks
Mean change in readiness to quit
Measured via the Readiness to Quit Ladder
Measured: 24 weeks
Mean change in nicotine dependence
Measured via the Heaviness of Smoking Index
Measured: Baseline
Mean change in nicotine dependence
Measured via the Heaviness of Smoking Index
Measured: 4 weeks
Mean change in nicotine dependence
Measured via the Heaviness of Smoking Index
Measured: 8 weeks
Mean change in nicotine dependence
Measured via the Heaviness of Smoking Index
Measured: 12 weeks
Mean change in nicotine dependence
Measured via the Heaviness of Smoking Index
Measured: 24 weeks
Mean change in cigarette use
Measured by by the self-reported number of cigarettes smoked per day
Measured: Baseline
Mean change in cigarette use
Measured by by the self-reported number of cigarettes smoked per day
Measured: 4 weeks
Mean change in cigarette use
Measured by by the self-reported number of cigarettes smoked per day
Measured: 8 weeks
Mean change in cigarette use
Measured by by the self-reported number of cigarettes smoked per day
Measured: 12 weeks
Mean change in cigarette use
Measured by by the self-reported number of cigarettes smoked per day
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start13 Sep 2021
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Why it stopped: Per institutional and PI recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shadia Jalal, Indiana University
- Investigators
- Shadia Jalal, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966807
- Sponsor's protocol ID
- IUSCC-0670
- Status last verified
- Jan 2024
- First submitted
- 18 Mar 2019
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting as a Potential Teachable Moment for Actively Smoking Family Members
- ClinicalTrials.gov ID
- NCT03966807
- Acronym / sponsor ID
- IUSCC-0670
- Conditions
- Lung Cancer
- Keywords
- lung cancer, caregiver
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Per institutional and PI recommendation
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital-based support | – | Behavioral: Digital-based supportDigital 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) | – | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Currently receiving formal tobacco dependence treatment- Nicotine replacement of any kind, varenicycline or Bupropion.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital-based supportDigital 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. | Behavioural | Digital-based support |
| 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. | Behavioural | traditional-based support +nicotine replacement therapy(NRT) |
Primary outcome
7-day point prevalence of self -reported smoking cessation
Time frame: 4 weeks
7-day point prevalence of self -reported smoking cessation
Time frame: 8 weeks
7-day point prevalence of self -reported smoking cessation
Time frame: 12 weeks
7-day point prevalence of self -reported smoking cessation
Time frame: 24 weeks
Willingness to quit
Time frame: 4 weeks
Willingness to quit
Time frame: 8 weeks
Willingness to quit
Time frame: 12 weeks
Willingness to quit
Time frame: 24 weeks
Preference for type of cessation intervention modality
Time frame: 4 weeks
digital versus traditional support with nicotine replacement therapy [NRT]
Preference for type of cessation intervention modality
Time frame: 8 weeks
digital versus traditional support with nicotine replacement therapy [NRT]
Preference for type of cessation intervention modality
Time frame: 12 weeks
digital versus traditional support with nicotine replacement therapy [NRT]
Preference for type of cessation intervention modality
Time frame: 24 weeks
digital versus traditional support with nicotine replacement therapy [NRT]
15 secondary outcomes
Mean change in readiness to quit
Time frame: Baseline
Mean change in readiness to quit
Time frame: 4 weeks
Mean change in readiness to quit
Time frame: 8 weeks
Mean change in readiness to quit
Time frame: 12 weeks
Mean change in readiness to quit
Time frame: 24 weeks
Mean change in nicotine dependence
Time frame: Baseline
Mean change in nicotine dependence
Time frame: 4 weeks
Mean change in nicotine dependence
Time frame: 8 weeks
Mean change in nicotine dependence
Time frame: 12 weeks
Mean change in nicotine dependence
Time frame: 24 weeks
Mean change in cigarette use
Time frame: Baseline
Mean change in cigarette use
Time frame: 4 weeks
Mean change in cigarette use
Time frame: 8 weeks
Mean change in cigarette use
Time frame: 12 weeks
Mean change in cigarette use
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Per institutional and PI recommendation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shadia Jalal, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Per institutional and PI recommendation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence of self -reported smoking cessation (time frame: 4 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.