- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03668769
Quitting Schedule Mobile Smartphone Application in Helping Participants to Quit Smoking
Project Quitting Schedule
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Prevention (smoking reduction, Quitting Schedule mobile app)
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. |
Ancillary studies
Ancillary studies
Use Quitting Schedule mobile smartphone app
Other Names:
Participate in individual smoking cessation program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Up to 5 weeks
|
|
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Pre-testing of the app
Time Frame: Up to 5 weeks
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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.
|
Up to 5 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Cinciripini, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-0516 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2018-01820 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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