Smoking CessationNCT05038852
Acceptability of Mobile Applications (Apps) to Enhance Smoking Cessation in a Clinical Tobacco Treatment Program - A Pilot Study
A study testing smartphone applications in people with Smoking Cessation and Tobacco, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
We will conduct a small-scale randomized controlled trial (RCT) with 24 adult smokers enrolled in the TTP. Participants will receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Tobacco
- What is being tested?
- smartphone applications
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2019to 2 Feb 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MD Anderson patient between the ages of 18 to 65
- current smoker (i.e., at least 1 cigarette or e-cig per day)
- smoking for at least one year,
- willing to set a quit date in the next 30 days,
- not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program
- English speaking and ability to read and comprehend English, and 7) currently own an iOS mobile phone (iPhone) using iOS 9.0 or later and reports regular use (at least weekly) of at least 1 iOS app.
Who cannot join
- endorsing current suicidal ideation or intent,
- meeting criteria for a current Major Depressive Episode measured by the PHQ-9,
- any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator,
- subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study.
- Pregnant women will not be excluded from participating in the study and any decisions about potential pharmacotherapy will be done as standard of care in the Tobacco Treatment Program, including a consultation with the medical team and a joint decision-making process with the patient to determine the best course of treatment given all co-morbid medical conditions.
Trial locations and contacts
1 site in 1 country.
About this study
We will conduct a small-scale randomized controlled trial (RCT) with 24 adult smokers enrolled in the TTP. Participants will receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax). All participants will be receiving tobacco cessation treatment in the Tobacco Treatment Program at MD Anderson as standard of care.
Read the detailed description
The aims of this pilot protocol are to test the adherence, acceptability, user satisfaction, and preliminary efficacy of a smartphone mobile health app, Free4Good, which incorporates skills training in positive psychology vs. a relaxation app, Breathe2Relax (control condition), in a small randomized controlled trial of smokers (N = 24). Adherence will be measured directly through app usage data. Acceptability and user satisfaction will be measured via specific items included on a User Satisfaction Questionnaire. Efficacy outcomes include evidence of increased engagement in positive psychology-related quitting strategies (measured by the Quitting Strategies Questionnaire) and smoking abstinence.
Exploratory analyses including covariates such as nicotine dependence, mood, and depressive symptoms may be examined as appropriate, as these measures have been shown to predict abstinence outcomes in a variety of studies.1-4 Changes in mood and/or depressive symptoms may also be characterized
- Conditions
- Smoking Cessation, Tobacco
- Being tested
- smartphone applications
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone applicationsDevice
app is designed to help you learn relaxation skills.
smartphone applicationsDevice
app is designed to help you increase your positive feelings, behaviors, and thoughts.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 smartphone applications | Other | app is designed to help you learn relaxation skills Receives: Device: smartphone applications |
| Group 2 smartphone applications | Other | app is designed to help you increase your positive feelings, behaviors, and thoughts. Receives: Device: smartphone applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the adherence of a smartphone mobile health app.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start12 Apr 2019
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
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 M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Minnix, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038852
- Sponsor's protocol ID
- 2018-0984
- Other IDs
- NCI-2021-09413
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability of Mobile Applications (Apps) to Enhance Smoking Cessation in a Clinical Tobacco Treatment Program - A Pilot Study
- ClinicalTrials.gov ID
- NCT05038852
- Acronym / sponsor ID
- 2018-0984
- Conditions
- Smoking Cessation, Tobacco
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 9 Sep 2021 (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.
We will conduct a small-scale randomized controlled trial (RCT) with 24 adult smokers enrolled in the TTP. Participants will receive either the Free4Good mobile app for positive psychology skills training or a breathing relaxation mobile app control (Breathe2Relax). All participants will be receiving tobacco cessation treatment in the Tobacco Treatment Program at MD Anderson as standard of care.
Detailed description
The aims of this pilot protocol are to test the adherence, acceptability, user satisfaction, and preliminary efficacy of a smartphone mobile health app, Free4Good, which incorporates skills training in positive psychology vs. a relaxation app, Breathe2Relax (control condition), in a small randomized controlled trial of smokers (N = 24). Adherence will be measured directly through app usage data. Acceptability and user satisfaction will be measured via specific items included on a User Satisfaction Questionnaire. Efficacy outcomes include evidence of increased engagement in positive psychology-related quitting strategies (measured by the Quitting Strategies Questionnaire) and smoking abstinence.
Exploratory analyses including covariates such as nicotine dependence, mood, and depressive symptoms may be examined as appropriate, as these measures have been shown to predict abstinence outcomes in a variety of studies.1-4 Changes in mood and/or depressive symptoms may also be characterized
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 smartphone applications | Other | Device: smartphone applicationsapp is designed to help you learn relaxation skills |
| Group 2 smartphone applications | Other | Device: smartphone applicationsapp is designed to help you increase your positive feelings, behaviors, and thoughts. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- MD Anderson patient between the ages of 18 to 65
- current smoker (i.e., at least 1 cigarette or e-cig per day)
- smoking for at least one year,
- willing to set a quit date in the next 30 days,
- not engaged in smoking cessation treatment other than the MDACC Tobacco Treatment Program
Key exclusion criteria (5 listed)
- endorsing current suicidal ideation or intent,
- meeting criteria for a current Major Depressive Episode measured by the PHQ-9,
- any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator or Collaborator,
- subject considered by the investigator an unsuitable candidate for receipt of a smoking cessation treatment or unstable to be followed up throughout the entire duration of the study.
- Pregnant women will not be excluded from participating in the study and any decisions about potential pharmacotherapy will be done as standard of care in the Tobacco Treatment Program, including a consultation with the medical team and a joint decision-making process with the patient to determine the best course of treatment given all co-morbid medical conditions.
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 |
|---|---|---|
| smartphone applicationsapp is designed to help you learn relaxation skills. | Device | Group 1 smartphone applications, Group 2 smartphone applications |
| smartphone applicationsapp is designed to help you increase your positive feelings, behaviors, and thoughts. | Device | Group 1 smartphone applications, Group 2 smartphone applications |
Primary outcome
To assess the adherence of a smartphone mobile health app.
Time frame: through study completion, an average of 1 year
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 16 Jul 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
Jennifer Minnix principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smartphone applications in people with Smoking Cessation and Tobacco, run by M.D. Anderson Cancer Center 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 6 inclusion and 5 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 16 Jul 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.
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?
To assess the adherence of a smartphone mobile health app. (time frame: through study completion, an average of 1 year). 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 Jul 2026.