SmokingNCT04691297
Digitally Enhanced Smoking Cessation for High Risk Smokers
A study testing Escape in people with Smoking and Smoking Cessation, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care. Read more about this study
- Who is it for?
- Ages 55 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation, Lung Cancer Screening
- What is being tested?
- Escape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2021to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55 to 77 years of age
- No previous history of lung cancer
- ECOG performance status < 2
- ≥ 30 pack year smoking history
- Smoke ≥ 5 cigarettes/day
- Own a mobile phone with access to a video call application
Show all 12Show fewer
- Has a primary care provider (PCP)
- Provide contact information for the PCP
- Active health insurance
- Has not had LDCT screening
- English speaking
- Can complete an interview
Who cannot join
- Hospitalization for severe mental illness within the last year.
- The following special populations will not be included
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
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: A Digitally-enhanced Smoking Cessation Intervention for High-risk Smokers: Phase II
This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening.
In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care.
The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening.
.
Read the detailed description
- This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. The research study procedures include: screening for eligibility and study interventions including participation in counseling and completion of questionnaires by e-mail, phone or in-person.
- This research study involves participating in either the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program or the usual care. Participants will be randomized into one of two groups:
- ESCAPE: The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening
- Usual Care: The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks
- Participants will be in this research study for up to 6-months.
- It is expected that about 250 people will take part in this research study.
- Being tested
- Escape, Standard Care
- Keywords
- Smoking, Smoking Cessation, Lung Cancer Screening, Smoking, Tobacco, Smoking Behaviors
- Medical subject headings
- Smoking, Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscapeOther
The ESCAPE intervention consists of five components:1) behavioral counseling, 2) the use of NRT, 3) digital SNC 4) decision aid about LDCT screening, and 5) a letter and educational materials sent to the primary care provider.
Standard CareOther
Participants in the standard care arm (brief advice and referral to quit line), will be referred to the MA Quitline which provides free NRT by the study team and will receive an educational brochure related to lung cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Escape | Experimental | The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening Receives: Other: Escape |
| Standard Care | Experimental | The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks and an educational brochure about lung cancer screening Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence smoking cessation rate
biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,
Measured: 3 months
7-day point prevalence smoking cessation rate
biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,
Measured: 6 months
number of cigarettes smoked/day
self-report number of cigarettes will be compared with exact Poisson test.
Measured: 3 months
number of cigarettes smoked/day
self-report number of cigarettes will be compared with exact Poisson test.
Measured: 6 months
Lung cancer screening behavior measure
(stage of low-dose computed tomography [LDCT] screening adoption) Lung Cancer Screening Behaviors[20] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,
Measured: 3 Months
Lung cancer screening behavior measure
(stage of low-dose computed tomography [LDCT] screening adoption) Lung Cancer Screening Behaviors[20] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,
Measured: 6 months
Secondary outcomes (8)
Completion rate
The evaluation of the storytelling narrative communication at 1 and 3 months will be defined as follows:1) > 80% receipt and completion rate of watching the SNC digitalized videos.
Descriptive statistics (estimate and 95% CI) will be used to report completion rate.
Measured: 1 month
Completion rate
The evaluation of the storytelling narrative communication at 1 and 3 months will be defined as follows:1) > 80% receipt and completion rate of watching the SNC digitalized videos.
Descriptive statistics (estimate and 95% CI) will be used to report completion rate.
Measured: 3 months
Percentage of the group perceive the film as just right in length
defined as > 80% of the group perceive the film as just right in length in addition to favorable comments, the Narrative Engagement Scale scores are ≥ to the established means ). Descriptive statistics (estimate and 95% CI) will be used to report percentage and one-sample t-test will be used to compare Narrative Engagement Scale scores to the established means.
Measured: 1 month
Percentage of the group indicate that the film would have value to others
> 80% of the group comments indicate that the film would have value to others and the Narrative Engagement Scale scores are ≥ to the established means. Descriptive statistics (estimate and 95% CI) will be used to report percentage and one-sample t-test will be used to compare Narrative Engagement Scale scores to the established means.
Measured: 3 months
Narrative Engagement Scale scores
The ratings of SNC videos will be evaluated using the Narrative Engagement Scale that will be administered at 1 and 3 months [37] The scale is a paper and pencil questionnaire developed to measure the extent to which the viewer of narratives in a variety of forms (film, TV etc.) becomes engaged, transported, or immersed in the narrative and the potential of the narrative to affect change in story-related attitudes and beliefs. The scale scores range from 1-7 with 7 indicating greater engagement.
Measured: 1 month
Narrative Engagement Scale scores
The ratings of SNC videos will be evaluated using the Narrative Engagement Scale that will be administered at 1 and 3 months [37] The scale is a paper and pencil questionnaire developed to measure the extent to which the viewer of narratives in a variety of forms (film, TV etc.) becomes engaged, transported, or immersed in the narrative and the potential of the narrative to affect change in story-related attitudes and beliefs. The scale scores range from 1-7 with higher scores indicating greater engagement.
Measured: 3 months
Polygenic risk score (PRS)
We will construct three PRS. The first will be based on the lead single nucleotide polymorphisms (SNPs) from 183 independent genetic loci associated at genome-wide significance (p<5x10-8) with ever smoking status in adults from the UK Biobank and the Tobacco and Alcohol Genetic Consortium. The risk will be calculated as the weighted sum of each genetic variant, under an additive genetic model, counting the number of copies of the risk increasing allele. The weights will be proportional to the estimated effect size of each SNP. The second risk score will be constructed from a larger set of SNPs (~1 million) from the same GWAS using LDPred that allows for the construction of more powerful PRSs for specific racial groups using linkage disequilibrium information from large genetic reference panels. Finally, we will also construct a PRS based on the GWAS results for the largest available study specifically for nicotine dependence using the LDPred approach.
Measured: 6 months
Qualitative interviews
A semi-structured interview will be conducted with participants. Topics for the interview guide include; 1) perceptions of genomic evaluation, 2) experiences for providing risk information, 3) preferences for receiving risk information, 4) experiences with the study interventions, 5) suggestions for program improvements.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Feb 2023
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for Cancer Research
- Responsible party
- Principal investigator, Mary E. Cooley, Phd, Dana-Farber Cancer Institute
- Investigators
- Mary E. Cooley, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691297
- Sponsor's protocol ID
- 20-457
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2020
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digitally-enhanced Smoking Cessation Intervention for High-risk Smokers: Phase II
- ClinicalTrials.gov ID
- NCT04691297
- Acronym / sponsor ID
- 20-457
- Keywords
- Smoking, Smoking Cessation, Lung Cancer Screening, Smoking, Tobacco, Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Association for Cancer Research
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Dec 2020 (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.
This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening.
In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care.
The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening.
.
Detailed description
- This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. The research study procedures include: screening for eligibility and study interventions including participation in counseling and completion of questionnaires by e-mail, phone or in-person.
- This research study involves participating in either the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program or the usual care. Participants will be randomized into one of two groups:
- ESCAPE: The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening
- Usual Care: The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks
- Participants will be in this research study for up to 6-months.
- It is expected that about 250 people will take part in this research study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escape | Experimental | Other: EscapeThe ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening |
| Standard Care | Experimental | Other: Standard CareThe usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks and an educational brochure about lung cancer screening |
Who may qualify
- Ages
- 55 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 55 to 77 years of age
- No previous history of lung cancer
- ECOG performance status < 2
- ≥ 30 pack year smoking history
- Smoke ≥ 5 cigarettes/day
Key exclusion criteria (6 listed)
- Hospitalization for severe mental illness within the last year.
- The following special populations will not be included
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 |
|---|---|---|
| EscapeThe ESCAPE intervention consists of five components:1) behavioral counseling, 2) the use of NRT, 3) digital SNC 4) decision aid about LDCT screening, and 5) a letter and educational materials sent to the primary care provider. | Other | Escape |
| Standard CareParticipants in the standard care arm (brief advice and referral to quit line), will be referred to the MA Quitline which provides free NRT by the study team and will receive an educational brochure related to lung cancer screening. | Other | Standard Care |
Primary outcome
7-day point prevalence smoking cessation rate
Time frame: 3 months
biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,
7-day point prevalence smoking cessation rate
Time frame: 6 months
biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,
number of cigarettes smoked/day
Time frame: 3 months
self-report number of cigarettes will be compared with exact Poisson test.
number of cigarettes smoked/day
Time frame: 6 months
self-report number of cigarettes will be compared with exact Poisson test.
Lung cancer screening behavior measure
Time frame: 3 Months
(stage of low-dose computed tomography [LDCT] screening adoption) Lung Cancer Screening Behaviors[20] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,
Lung cancer screening behavior measure
Time frame: 6 months
(stage of low-dose computed tomography [LDCT] screening adoption) Lung Cancer Screening Behaviors[20] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,
8 secondary outcomes
Completion rate
Time frame: 1 month
Completion rate
Time frame: 3 months
Percentage of the group perceive the film as just right in length
Time frame: 1 month
Percentage of the group indicate that the film would have value to others
Time frame: 3 months
Narrative Engagement Scale scores
Time frame: 1 month
Narrative Engagement Scale scores
Time frame: 3 months
Polygenic risk score (PRS)
Time frame: 6 months
Qualitative interviews
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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 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 Escape in people with Smoking and Smoking Cessation, 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 12 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 smoking cessation rate (time frame: 3 months). The study lists 6 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 19 Dec 2025.