Cigarette SmokerNCT03668769
Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking
A study testing Internet Mobile Technology, Interview and Questionnaire Administration in people with Cigarette Smoker and Current Every Day Smoker, run by M.D. Anderson Cancer Center.
Trial summary
This trial studies how well a mobile smartphone application called Quitting Schedule works in helping participants to quit smoking. Quitting Schedule is based on WebCASSI, a computer-based initiative that offered state of-the-art smoking cessation treatment and counseling to MD Anderson Cancer Center (MDACC) patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoker, Current Every Day Smoker, Current Smoker
- What is being tested?
- Internet Mobile Technology, Interview and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2017to 4 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smokers (those who smoke at least 5 cigarettes a day; confirmed with carbon monoxide (CO) levels equal or above 7 parts per million ) newly enrolled in the Tobacco Treatment Program at MDACC (Aim 2 )
- Male or female (Aim 2)
- Adult cancer patients - 18 years or older (Aim 2)
- Current smokers seeking care at the Tobacco Treatment Program at MD Anderson and at Houston area community services who have smoked at least 100 cigarettes in lifetime
- Willing to download and use the app Quitting Schedule (Aim 2)
- Willing to set a quit smoking date within 5 weeks of the enrollment (Aim 2)
- Ownership of an iPhone or Android smartphone (Aim 2)
Who cannot join
- Unwillingness to participate in the study (Aim 2)
- Enrolled in another cessation program (Aim 2)
- Current use of NRT or other smoking cessation medications,e.g. Varenicline or Bupropion outside of the MD Anderson Institution (Aim 2)
- Expired CO levels below 7ppm (Aim 2)
About this study
Official title: Project Quitting Schedule
This trial studies how well a mobile smartphone application called Quitting Schedule works in helping participants to quit smoking. Quitting Schedule is based on WebCASSI, a computer-based initiative that offered state of-the-art smoking cessation treatment and counseling to MD Anderson Cancer Center (MDACC) patients and served as a portal for non-patients to find information regarding smoking cessation advice and treatments. Quitting Schedule may help participants to quit smoking.
Read the detailed description
PRIMARY OBJECTIVES:
- To adapt the internal algorithms of the scheduled reduced smoking approach in Computer Assisted Stop Smoking Intervention for the World Wide Web (WebCASSI) into a smartphone application (app): Quitting Schedule.
II. Once the smartphone app is developed, a pretesting phase with smoker seeking care at MDACC Tobacco Treatment Program or another community service such as Equality Texas, Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ) Advisory Board of the City of Houston, Montrose Center, Avenue 360 and Lesbian Health Initiative will follow.
III. To culturally and linguistically adapt Quitting Schedule app into Spanish language.
IV. To implement a feasibility trial in IDC (Colombia), INCan (Mexico), and INEN (Peru).
OUTLINE:
AIM I: Participants follow an individually tailored gradual reduction of smoking schedule for 5 weeks while MDACC eHealth adapts WebCASSI into a smartphone app: Quitting Schedule.
AIM II: Participants pre-test the Quitting Schedule mobile smartphone app for 5 weeks.
- Being tested
- Internet Mobile Technology, Interview, Questionnaire Administration, Smoking Cessation Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Mobile TechnologyOther
Also called www-mobile
Use Quitting Schedule mobile smartphone app
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Participate in individual smoking cessation program
| Study group | Role | What they receive |
|---|---|---|
| Prevention (smoking reduction, Quitting Schedule mobile app) | Experimental | AIM I: Participants follow an individually tailored gradual reduction of smoking schedule for 5 weeks while MDACC eHealth adapts WebCASSI into a smartphone app: Quitting Schedule.
AIM II: Participants pre-test the Quitting Schedule mobile smartphone app for 5 weeks. Receives: Other: Internet Mobile Technology; Other: Interview; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation of the programmatic infrastructure of WebCASSI (Computer Assisted Stop Smoking Intervention for the World Wide Web) into a more-portable table and smartphone application (app) that will be available both in English and Spanish
Measured: Up to 5 weeks
Pre-testing of the app
A focus group will be used in order to provide feedback on the features of the app in relation to usability for smoking cessation and future app development.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start27 Mar 2017
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Why it stopped: 0 participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokerStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Paul Cinciripini, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668769
- Sponsor's protocol ID
- 2016-0516
- Other IDs
- NCI-2018-01820, 2016-0516, P30CA016672
- Status last verified
- Feb 2024
- First submitted
- 11 Sep 2018
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Quitting Schedule
- ClinicalTrials.gov ID
- NCT03668769
- Acronym / sponsor ID
- 2016-0516
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 participant accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 13 Sep 2018 (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 trial studies how well a mobile smartphone application called Quitting Schedule works in helping participants to quit smoking. Quitting Schedule is based on WebCASSI, a computer-based initiative that offered state of-the-art smoking cessation treatment and counseling to MD Anderson Cancer Center (MDACC) patients and served as a portal for non-patients to find information regarding smoking cessation advice and treatments. Quitting Schedule may help participants to quit smoking.
Detailed description
PRIMARY OBJECTIVES:
- To adapt the internal algorithms of the scheduled reduced smoking approach in Computer Assisted Stop Smoking Intervention for the World Wide Web (WebCASSI) into a smartphone application (app): Quitting Schedule.
II. Once the smartphone app is developed, a pretesting phase with smoker seeking care at MDACC Tobacco Treatment Program or another community service such as Equality Texas, Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ) Advisory Board of the City of Houston, Montrose Center, Avenue 360 and Lesbian Health Initiative will follow.
III. To culturally and linguistically adapt Quitting Schedule app into Spanish language.
IV. To implement a feasibility trial in IDC (Colombia), INCan (Mexico), and INEN (Peru).
OUTLINE:
AIM I: Participants follow an individually tailored gradual reduction of smoking schedule for 5 weeks while MDACC eHealth adapts WebCASSI into a smartphone app: Quitting Schedule.
AIM II: Participants pre-test the Quitting Schedule mobile smartphone app for 5 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (smoking reduction, Quitting Schedule mobile app) | Experimental | Other: Internet Mobile Technology, Other: Interview, Other: Questionnaire Administration, Behavioral: Smoking Cessation InterventionAIM I: Participants follow an individually tailored gradual reduction of smoking schedule for 5 weeks while MDACC eHealth adapts WebCASSI into a smartphone app: Quitting Schedule. AIM II: Participants pre-test the Quitting Schedule mobile smartphone app for 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current smokers (those who smoke at least 5 cigarettes a day; confirmed with carbon monoxide (CO) levels equal or above 7 parts per million ) newly enrolled in the Tobacco Treatment Program at MDACC (Aim 2 )
- Male or female (Aim 2)
- Adult cancer patients - 18 years or older (Aim 2)
- Current smokers seeking care at the Tobacco Treatment Program at MD Anderson and at Houston area community services who have smoked at least 100 cigarettes in lifetime
- Willing to download and use the app Quitting Schedule (Aim 2)
Key exclusion criteria (4 listed)
- Unwillingness to participate in the study (Aim 2)
- Enrolled in another cessation program (Aim 2)
- Current use of NRT or other smoking cessation medications,e.g. Varenicline or Bupropion outside of the MD Anderson Institution (Aim 2)
- Expired CO levels below 7ppm (Aim 2)
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 |
|---|---|---|
| Internet Mobile TechnologyAlso: www-mobileUse Quitting Schedule mobile smartphone app | Other | Prevention (smoking reduction, Quitting Schedule mobile app) |
| InterviewAncillary studies | Other | Prevention (smoking reduction, Quitting Schedule mobile app) |
| Questionnaire AdministrationAncillary studies | Other | Prevention (smoking reduction, Quitting Schedule mobile app) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsParticipate in individual smoking cessation program | Behavioural | Prevention (smoking reduction, Quitting Schedule mobile app) |
Primary outcome
Adaptation of the programmatic infrastructure of WebCASSI (Computer Assisted Stop Smoking Intervention for the World Wide Web) into a more-portable table and smartphone application (app) that will be available both in English and Spanish
Time frame: Up to 5 weeks
Pre-testing of the app
Time frame: Up to 5 weeks
A focus group will be used in order to provide feedback on the features of the app in relation to usability for smoking cessation and future app development.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Paul Cinciripini principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Internet Mobile Technology, Interview and Questionnaire Administration in people with Cigarette Smoker and Current Every Day Smoker, run by M.D. Anderson Cancer Center.
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: withdrawn, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Adaptation of the programmatic infrastructure of WebCASSI (Computer Assisted Stop Smoking Intervention for the World Wide Web) into a more-portable table and smartphone application (app) that will be available both in English and Spanish (time frame: Up to 5 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?
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 23 Feb 2024.