Smoking CessationNCT02816697
Implementation of a System-level Tobacco Treatment Intervention
A study testing CEASE in people with Smoking Cessation and Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The proposed study plans to adapt and study the implementation and effectiveness of integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the thoracic oncology setting using mixed methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Lung Cancer
- What is being tested?
- CEASE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2016to Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Have an actual or potential diagnosis of thoracic malignancy
- Able to read and write in English.
- Current or recent former smoker (defined as having smoked within past 6 months)
- Must have an active telephone number.
Who cannot join
- Former smoker greater than 6 months.
- Have any of the below conditions needing immediate medical intervention
- Hypercalcemia causing lethargy and confusion,
- Acute respiratory distress
- Dehydration
- Hypotension
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Implementation of a System-level Tobacco Treatment Intervention in Thoracic Oncology
The proposed study plans to adapt and study the implementation and effectiveness of integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the thoracic oncology setting using mixed methods.
Read the detailed description
In particular the study aims to see if participants are asked about their smoking status and what services are offered if someone indicates being a former or current smoker. Findings from this study will help improve a standard of care at this clinic and allow us to understand what type of tobacco treatment services are preferred by patients.
- Adaption of CEASE will entail exit interviews with patients and individual interviews with clinical staff to identify and address facilitators and barriers to the implementation process.
- Effectiveness of CEASE will be measured through questionnaires \& biochemical verification of smoking status using a pre-test/post-test study design before (usual care)and after implementation (CEASE)
- Conditions
- Smoking Cessation, Lung Cancer
- Being tested
- CEASE, Usual Care Tobacco Treatment Services
- Keywords
- Smoking Habits
- Medical subject headings
- Smoking Cessation, Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEASEOther
- Clinical and Community Effort Against Secondhand Smoke Exposure (CEASE)
- CEASE is a system-level intervention that integrates tobacco-use screening, cessation assistance, and referral to outside services into routine visits
Usual Care Tobacco Treatment ServicesOther
| Study group | Role | What they receive |
|---|---|---|
| Cease-Aim 1 | Active comparator | * Cease Implementation
* 100 Patients after CEASE Implementation
* Exit Interview and Tobacco Use Survey Receives: Other: CEASE |
| Pre Cease Implementation Aim 2 | Active comparator | 50 Current or former smokers (3 months +/-2 month) patients in usual care (before CEASE implementation)
* Tobacco Use Survey (Baseline,1- 6 Months)
* Biochemical verification Receives: Other: Usual Care Tobacco Treatment Services |
| After Cease Implementation Aim 2 | Experimental | 50 Current or former smokers (3 months +/-2 month)
* Tobacco Use Survey (Baseline,1- 6 Months)
* Biochemical verification Receives: Other: CEASE |
| Usual Care-Aim 1 | Active comparator | Usual Care Tobacco Treatment Services
* 100 patients in usual care
* Exit Interview and Tobacco Use Survey Receives: Other: Usual Care Tobacco Treatment Services |
| Clinician and Staff Survey | No intervention | - Interview clinicians and support staff (40) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation Rate
Biochemical verification of smoking cessation
Measured: 6 Months
Secondary outcomes (1)
Documentation of tobacco treatment
Assess documentation of smoking assessment and provision of treatment ( medication and referral for behavioral counseling)
Measured: 2 months after CEASE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion1 Dec 2022
- Study completionApr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Responsible party
- Principal investigator, Mary E. Cooley, Phd, Dana-Farber Cancer Institute
- Investigators
- Mary E Cooley, PhD, RN, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816697
- Sponsor's protocol ID
- 16-208
- Status last verified
- Apr 2026
- First submitted
- 23 Jun 2016
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a System-level Tobacco Treatment Intervention in Thoracic Oncology
- ClinicalTrials.gov ID
- NCT02816697
- Acronym / sponsor ID
- 16-208
- Conditions
- Smoking Cessation, Lung Cancer
- Keywords
- Smoking Habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital
- Study start
- Jun 2016 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- Apr 2026 (actual)
- First posted
- 28 Jun 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 proposed study plans to adapt and study the implementation and effectiveness of integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the thoracic oncology setting using mixed methods.
Detailed description
In particular the study aims to see if participants are asked about their smoking status and what services are offered if someone indicates being a former or current smoker. Findings from this study will help improve a standard of care at this clinic and allow us to understand what type of tobacco treatment services are preferred by patients.
- Adaption of CEASE will entail exit interviews with patients and individual interviews with clinical staff to identify and address facilitators and barriers to the implementation process.
- Effectiveness of CEASE will be measured through questionnaires \& biochemical verification of smoking status using a pre-test/post-test study design before (usual care)and after implementation (CEASE)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cease-Aim 1 | Active comparator | Other: CEASE* Cease Implementation * 100 Patients after CEASE Implementation * Exit Interview and Tobacco Use Survey |
| Pre Cease Implementation Aim 2 | Active comparator | Other: Usual Care Tobacco Treatment Services50 Current or former smokers (3 months +/-2 month) patients in usual care (before CEASE implementation) * Tobacco Use Survey (Baseline,1- 6 Months) * Biochemical verification |
| After Cease Implementation Aim 2 | Experimental | Other: CEASE50 Current or former smokers (3 months +/-2 month) * Tobacco Use Survey (Baseline,1- 6 Months) * Biochemical verification |
| Usual Care-Aim 1 | Active comparator | Other: Usual Care Tobacco Treatment ServicesUsual Care Tobacco Treatment Services * 100 patients in usual care * Exit Interview and Tobacco Use Survey |
| Clinician and Staff Survey | No intervention | –- Interview clinicians and support staff (40) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Have an actual or potential diagnosis of thoracic malignancy
- Able to read and write in English.
- Current or recent former smoker (defined as having smoked within past 6 months)
- Must have an active telephone number.
Key exclusion criteria (6 listed)
- Former smoker greater than 6 months.
- Have any of the below conditions needing immediate medical intervention
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 |
|---|---|---|
| CEASE* Clinical and Community Effort Against Secondhand Smoke Exposure (CEASE) * CEASE is a system-level intervention that integrates tobacco-use screening, cessation assistance, and referral to outside services into routine visits | Other | After Cease Implementation Aim 2, Cease-Aim 1 |
| Usual Care Tobacco Treatment Services | Other | Pre Cease Implementation Aim 2, Usual Care-Aim 1 |
Primary outcome
Smoking cessation Rate
Time frame: 6 Months
Biochemical verification of smoking cessation
1 secondary outcome
Documentation of tobacco treatment
Time frame: 2 months after CEASE
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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Mary E Cooley, PhD, RN principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEASE in people with Smoking Cessation and Lung Cancer, run by Dana-Farber Cancer Institute 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 5 inclusion and 6 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 16 Apr 2026. 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 Rate (time frame: 6 Months). 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 16 Apr 2026.