Smoking CessationNCT02658032
Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
A study testing personalized cessation care and bio feedback in people with Smoking Cessation and Biofeedback, run by Yale University at 2 sites in United States.
Trial summary
The purpose of this study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction in patients who are screened for lung cancer or are eligible for lung cancer screening. Each intervention will be compared to standard of care. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Smoking Cessation, Biofeedback
- What is being tested?
- personalized cessation care and bio feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Oct 2020
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current Smoker.
- 20 pack per year smoking history.
- Eligible for the Smilow treatment program.
- Willing to enroll in smoking cessation program.
- Willing to be randomized in smoking cessation study.
- English speaking.
Who cannot join
- Dementia or current serious psychiatric or unstable medical illness.
- Pregnancy or breast feeding.
- Known fat malabsorption diseases that may affect skin carotenoid status.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina: Hollings Cancer Center
Charleston, South Carolina, 29425
Yale University
New Haven, Connecticut, 06511
About this study
The purpose of this study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction in patients who are screened for lung cancer or are eligible for lung cancer screening. Each intervention will be compared to standard of care. The first intervention will be a personalized message intervention, the second intervention will consist of a biofeedback-based intervention.
Read the detailed description
The primary aims of this study are to test the efficacy two types of smoking cessation methods (compared to standard care).
The aim of the first intervention is to evaluate the efficacy of a personalized message intervention in improving tobacco quit rates above and beyond standard care smoking cessation treatment in patients at risk for lung cancer. Messages will be designed specifically for patients at risk for lung cancer, personalized and presented in a gain-framed manner, taking into account demographics and smoking history.
The aim of the second intervention is to evaluate the efficacy of a novel, biofeedback-based intervention that provides personalized individual-level feedback on biomarkers of lung cancer risk and how they improve in response to cessation, delivered in a gain-framed way. The biomarkers include skin carotenoid status, spirometry, and plasma bilirubin, all of which improve with cessation. The study team will examine whether the biofeedback prevents relapse in those who quit and leads to reductions in smoking in lung nodule patients who failed to quit.
Additionally, this study will attempt to evaluate the impact of smoking cessation on miRNA profiles in human serum, especially miRNAs in the let-7 family, which are known to have tumor suppressor function, and which we hypothesize increase in response to cessation.
- Conditions
- Smoking Cessation, Biofeedback
- Being tested
- personalized cessation care, bio feedback, standard care
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized cessation careBehavioural
Individuals randomized to this condition will receive standard care (i.e., 5 counseling sessions and nicotine patch(NRT)) and 4 personalized videos with 5 packages of personalized print materials
bio feedbackBehavioural
Individuals randomized to this group will be provided with a personalized graph of their biomarker data from baseline, 6 and 8 weeks at the 8-week and 3-month study visits.
standard careOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Care/No Bio Feedback | Other | This arm will consist of those first randomized to be enrolled in the standard care arm and then those enrolled in the non bio feedback arm. Receives: Other: standard care |
| Standard Care/ Bio Feedback | Other | This arm will consist of those first randomized to be enrolled in the standard care arm and then those enrolled in the bio feedback arm. Receives: Behavioral: bio feedback; Other: standard care |
| Personalized Care/ No Bio Feedback | Other | This arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the non bio feedback arm. Receives: Behavioral: personalized cessation care; Other: standard care |
| Personalized Care/ Bio Feedback | Experimental | This arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the bio feedback arm. Receives: Behavioral: personalized cessation care; Behavioral: bio feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
Measured: 8 weeks
Number of cigarettes smoked
Number of cigarettes smoked will be assessed by self report. Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
Measured: 6 months
Secondary outcomes (4)
Smoking Cessation
Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
Measured: Baseline, 4 Weeks, 3 Months
Expired Air
A hand held spirometer will be used to measure the volume of air expired by the lungs.
Measured: Screening (1 week prior to baseline), Baseline, 8 Weeks, 3 Months, 6 Months
Skin Carotenoids
Skin carotenoids are measured with a 30-second scan of the skin with visible light can be used to quantify skin carotenoids rapidly and non-invasively. This study's method sufficiently measures carotenoid status in skin as a biomarker of response to a smoking cessation intervention.
Measured: Screening (1 week prior to baseline), Baseline, 6 Weeks, 8 Weeks, 3 Months, 6 Months
Plasma Bilirubin
3 mls of blood will be drawn into heparinized tubes, centrifuged, and plasma transferred to opaque tubes and analyzed on the Roche DPP Modular automated chemistry analyzer at the clinical lab, using the method of Jendrassik and Grof. While indirect (unconjugated) bilirubin is likely more relevant for health effects, it is very highly correlated with total bilirubin, which is more common for physicians to test and thus more relevant for translational purposes. Thus, total bilirubin will be used for feedback.
Measured: Screening (1 week prior to baseline), 6 Weeks, 8 Weeks, 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Yale 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brenda Cartmel, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658032
- Sponsor's protocol ID
- 1505015965
- Other IDs
- 1P50CA196530-01
- Status last verified
- Apr 2023
- First submitted
- 14 Jan 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cartmel B, Fucito LM, Bold KW, Neveu S, Li F, Rojewski AM, Gueorguieva R, O'Malley SS, Herbst RS, Toll BA. Effect of a Personalized Tobacco Treatment Intervention on Smoking Abstinence in Individuals Eligible for Lung Cancer Screening. J Thorac Oncol. 2024 Apr;19(4):643-649. doi: 10.1016/j.jtho.2023.11.012. Epub 2023 Nov 15.
PubMed 37977486
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
- ClinicalTrials.gov ID
- NCT02658032
- Acronym / sponsor ID
- 1505015965
- Conditions
- Smoking Cessation, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 18 Jan 2016 (estimated)
- 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 study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction in patients who are screened for lung cancer or are eligible for lung cancer screening. Each intervention will be compared to standard of care. The first intervention will be a personalized message intervention, the second intervention will consist of a biofeedback-based intervention.
Detailed description
The primary aims of this study are to test the efficacy two types of smoking cessation methods (compared to standard care).
The aim of the first intervention is to evaluate the efficacy of a personalized message intervention in improving tobacco quit rates above and beyond standard care smoking cessation treatment in patients at risk for lung cancer. Messages will be designed specifically for patients at risk for lung cancer, personalized and presented in a gain-framed manner, taking into account demographics and smoking history.
The aim of the second intervention is to evaluate the efficacy of a novel, biofeedback-based intervention that provides personalized individual-level feedback on biomarkers of lung cancer risk and how they improve in response to cessation, delivered in a gain-framed way. The biomarkers include skin carotenoid status, spirometry, and plasma bilirubin, all of which improve with cessation. The study team will examine whether the biofeedback prevents relapse in those who quit and leads to reductions in smoking in lung nodule patients who failed to quit.
Additionally, this study will attempt to evaluate the impact of smoking cessation on miRNA profiles in human serum, especially miRNAs in the let-7 family, which are known to have tumor suppressor function, and which we hypothesize increase in response to cessation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Care/No Bio Feedback | Other | Other: standard careThis arm will consist of those first randomized to be enrolled in the standard care arm and then those enrolled in the non bio feedback arm. |
| Standard Care/ Bio Feedback | Other | Behavioral: bio feedback, Other: standard careThis arm will consist of those first randomized to be enrolled in the standard care arm and then those enrolled in the bio feedback arm. |
| Personalized Care/ No Bio Feedback | Other | Behavioral: personalized cessation care, Other: standard careThis arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the non bio feedback arm. |
| Personalized Care/ Bio Feedback | Experimental | Behavioral: personalized cessation care, Behavioral: bio feedbackThis arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the bio feedback arm. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current Smoker.
- 20 pack per year smoking history.
- Eligible for the Smilow treatment program.
- Willing to enroll in smoking cessation program.
- Willing to be randomized in smoking cessation study.
Key exclusion criteria (3 listed)
- Dementia or current serious psychiatric or unstable medical illness.
- Pregnancy or breast feeding.
- Known fat malabsorption diseases that may affect skin carotenoid status.
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 |
|---|---|---|
| personalized cessation careIndividuals randomized to this condition will receive standard care (i.e., 5 counseling sessions and nicotine patch(NRT)) and 4 personalized videos with 5 packages of personalized print materials | Behavioural | Personalized Care/ Bio Feedback, Personalized Care/ No Bio Feedback |
| bio feedbackIndividuals randomized to this group will be provided with a personalized graph of their biomarker data from baseline, 6 and 8 weeks at the 8-week and 3-month study visits. | Behavioural | Personalized Care/ Bio Feedback, Standard Care/ Bio Feedback |
| standard care | Other | Personalized Care/ No Bio Feedback, Standard Care/ Bio Feedback, Standard Care/No Bio Feedback |
Primary outcome
Smoking Cessation
Time frame: 8 weeks
Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
Number of cigarettes smoked
Time frame: 6 months
Number of cigarettes smoked will be assessed by self report. Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
4 secondary outcomes
Smoking Cessation
Time frame: Baseline, 4 Weeks, 3 Months
Expired Air
Time frame: Screening (1 week prior to baseline), Baseline, 8 Weeks, 3 Months, 6 Months
Skin Carotenoids
Time frame: Screening (1 week prior to baseline), Baseline, 6 Weeks, 8 Weeks, 3 Months, 6 Months
Plasma Bilirubin
Time frame: Screening (1 week prior to baseline), 6 Weeks, 8 Weeks, 3 Months, 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 37977486Cartmel B, Fucito LM, Bold KW, Neveu S, Li F, Rojewski AM, Gueorguieva R, O'Malley SS, Herbst RS, Toll BA. Effect of a Personalized Tobacco Treatment Intervention on Smoking Abstinence in Individuals Eligible for Lung Cancer Screening. J Thorac Oncol. 2024 Apr;19(4):643-649. doi: 10.1016/j.jtho.2023.11.012. Epub 2023 Nov 15.
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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.
Brenda Cartmel, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized cessation care and bio feedback in people with Smoking Cessation and Biofeedback, run by Yale University at 2 sites 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Smoking Cessation (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658032, which also lists 1 linked publication.
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 21 Apr 2023.