Any Cancer TypePhase 1NCT06476548
Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors
A Phase 1 study testing EMI in people with Any Cancer Type, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to obtain feedback on a new quit-smoking treatment among individuals with a cancer diagnosis using a prototype app we developed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Cancer Type
- What is being tested?
- EMI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 26 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Having smoked at least one cigarette (even one or two puffs) within the past 30 days.
- Having been diagnosed with cancer.
- Willing to give quitting a try as part of the study.
- Having a smartphone that allows installation of the app.
- Willingness to download and use the app daily.
- Valid home address and functioning phone number.
- Being able to read, write, and speak English.
Who cannot join
- Being enrolled in a smoking cessation program.
- Current use of smoking cessation medications.
- Evidence of current psychosis.
- Current/planning pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to obtain feedback on a new quit-smoking treatment among individuals with a cancer diagnosis using a prototype app we developed.
Read the detailed description
The study aims to test the usability of the prototype app in conjunction with face-to-face brief cessation counseling and nicotine replacement therapy in a single-arm trial.
- Conditions
- Any Cancer Type
- Being tested
- EMI
- Keywords
- Smoking Cessation, Cancer Survivor
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMIDevice
Participants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches.
| Study group | Role | What they receive |
|---|---|---|
| Usability Testing | Experimental | Participants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app. Receives: Device: EMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Percentage of participants who downloaded the study's smartphone application and attended the first counseling session.
Measured: At 4 weeks
Likability of Mindfulness Practices
Participants will rate the likability of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely dislike) to 6 (Extremely like).
Measured: At 4 weeks
Utility of Mindfulness Practices
Participants will rate their perceived helpfulness of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely unhelpful) to 6 (Extremely helpful).
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start12 Jun 2024
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Any Cancer TypeStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research 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 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christine Vinci, PhD, Principal investigator, Moffitt Cancer CenterMin-Jeong Yang, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476548
- Sponsor's protocol ID
- MCC-22266
- Other IDs
- K99CA271040
- Status last verified
- Mar 2026
- First submitted
- 21 Jun 2024
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang MJ, Sutton SK, Cottrell-Daniels C, Ritterband LM, Blackwell R, Maconi ML, Poudel R, Pabbathi S, Simmons VN, Vinci C. Mindfulness-based ecological momentary intervention for smoking cessation to address cancer-related relapse risk factors: Intervention development and usability findings. Mindfulness (N Y). 2026 Mar 9;17(4):1101-19. doi: 10.1007/s12671-026-02775-0. Online ahead of print.
PubMed 41809575
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Ecological Momentary Intervention For Smoking Cessation Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT06476548
- Acronym / sponsor ID
- MCC-22266
- Conditions
- Any Cancer Type
- Keywords
- Smoking Cessation, Cancer Survivor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 26 Jun 2024 (actual)
- Results
- Posted 15 Jul 2025
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 the study is to obtain feedback on a new quit-smoking treatment among individuals with a cancer diagnosis using a prototype app we developed.
Detailed description
The study aims to test the usability of the prototype app in conjunction with face-to-face brief cessation counseling and nicotine replacement therapy in a single-arm trial.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usability Testing | Experimental | Device: EMIParticipants will receive brief counseling, nicotine replacement therapy, and intervention content delivered via the app. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having smoked at least one cigarette (even one or two puffs) within the past 30 days.
- Having been diagnosed with cancer.
- Willing to give quitting a try as part of the study.
- Having a smartphone that allows installation of the app.
- Willingness to download and use the app daily.
Key exclusion criteria (4 listed)
- Being enrolled in a smoking cessation program.
- Current use of smoking cessation medications.
- Evidence of current psychosis.
- Current/planning pregnancy or lactation.
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 |
|---|---|---|
| EMIParticipants will complete 3 counseling sessions (30 minutes), download and use a smartphone app for 4 weeks, complete 2 online surveys, and a brief phone call at the end of the study to provide feedback. In the first 3 weeks, participants will use the prototype app every day to complete ecological momentary assessments (EMAs), receive brief mindful skills, and practice formal mindfulness meditations (5-20 minutes). In the final week, participants will continue completing EMAs. Participants will also be provided with nicotine patches. | Device | Usability Testing |
Primary outcome
Retention Rate
Time frame: At 4 weeks
Percentage of participants who downloaded the study's smartphone application and attended the first counseling session.
Likability of Mindfulness Practices
Time frame: At 4 weeks
Participants will rate the likability of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely dislike) to 6 (Extremely like).
Utility of Mindfulness Practices
Time frame: At 4 weeks
Participants will rate their perceived helpfulness of mindfulness practices delivered through the study app on a 6-point Likert scale from 1 (Extremely unhelpful) to 6 (Extremely helpful).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41809575Yang MJ, Sutton SK, Cottrell-Daniels C, Ritterband LM, Blackwell R, Maconi ML, Poudel R, Pabbathi S, Simmons VN, Vinci C. Mindfulness-based ecological momentary intervention for smoking cessation to address cancer-related relapse risk factors: Intervention development and usability findings. Mindfulness (N Y). 2026 Mar 9;17(4):1101-19. doi: 10.1007/s12671-026-02775-0. Online ahead of print.
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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.
Christine Vinci, PhD principal investigator
Moffitt Cancer Center
Min-Jeong Yang, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMI in people with Any Cancer Type, run by H. Lee Moffitt Cancer Center and Research Institute 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 7 inclusion and 4 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 2 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention Rate (time frame: At 4 weeks). The study lists 3 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 NCT06476548, 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 2 Apr 2026.