Cigarette SmokerNCT01967082
APPSPIRE App in Preventing Students From Smoking
A study testing APPSPIRE, Focus Group and Survey Administration in people with Cigarette Smoker and Current Every Day Smoker, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
This trial studies how well APPSPIRE, a smartphone app, works in preventing students from smoking. Technology-driven intervention programs, such as the APPSPIRE app, have the potential to increase access to health behavior treatments and therapies, such as tobacco cessation support, and provide effective prevention… Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Cigarette Smoker, Current Every Day Smoker, Student
- What is being tested?
- APPSPIRE, Focus Group and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2013to 8 Jan 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 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Student at Houston Community College (HCC)
- Speak and read English
- Own an iPhone
- Be enrolled in at least one class at HCC
- Provide current contact information
- Smoke 1 or more cigarettes a day (cessation group)
- Have access to the internet (cessation and prevention/advocacy groups)
- Evidence of smoking susceptibility as defined by the Smoking Susceptibility Scale
Who cannot join
- Does not plan to continue as a student at their campus sometime during the year of the study (cessation and prevention/advocacy groups)
- Current tobacco use (prevention/advocacy group)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Community College
Houston, Texas, 77002
M D Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: APPSPIRE: Expanding the Reach of an Innovative Tobacco Control Program for Youth
This trial studies how well APPSPIRE, a smartphone app, works in preventing students from smoking. Technology-driven intervention programs, such as the APPSPIRE app, have the potential to increase access to health behavior treatments and therapies, such as tobacco cessation support, and provide effective prevention messaging.
Read the detailed description
PRIMARY OBJECTIVES:
- Develop a prototype of the APPSPIRE (phone application [app] of a smoking prevention interactive experience).
II. At post assessment, students enrolled in the study will qualitatively provide information about the usability and usefulness for the prevention and cessation sites.
III. Investigate frequency of use of and exposure to APPSPIRE modules via an objective measure of general use.
IV. Investigate how feasible the program will be. V. Obtain a maintained use of APPSPIRE with high completeness and extent of completion.
VI. Evaluate change in stage of change from baseline to about 1 and 4-month follow-ups among participants.
OUTLINE:
Participants attend an audio-taped focus group over 1 hour and are given the APPSPIRE app. After 1 and 4 months of using the app, participants complete a telephone survey over 1 hour to discuss how they liked the app and its usefulness.
- Conditions
- Cigarette Smoker, Current Every Day Smoker, Student
- Being tested
- APPSPIRE, Focus Group, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPSPIREBehavioural
Also called APPSPIRE Smartphone Application; APPSPIRE Smartphone App; APPSPIRE App; APPSPIRE Application
Given APPSPIRE app
Focus GroupBehavioural
Attend focus group
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Prevention (focus group, APPSPIRE app, survey) | Experimental | Participants attend an audio-taped focus group over 1 hour and are given the APPSPIRE app. After 1 and 4 months of using the app, participants complete a telephone survey over 1 hour to discuss how they liked the app and its usefulness. Receives: Behavioral: APPSPIRE; Behavioral: Focus Group; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of APPSPIRE application (app) use
Will be measured in minutes per day and with descriptive statistics. Will measure using mean, median and standard deviation for continuous variables.
Measured: Up to 4 months
The Feasibility of the tobacco control program.
Feasibly will be measured by multiplying the variable of two concepts: ease of use and ability to fit the program into routine schedules.
Measured: Up to 4 months
The Completeness with the Percentages of Participants surveyed.
Completeness will be measured as the percentage of participants who continue to use AppSPIRE until the 4 month follow up survey.
Measured: Up to 4 months
The extent of completion for the modules AppSPIRE.
The extent of completion includes the various modules of AppSPIRE. High extent of completion is obtained if 75% of the participants have completed all modules of AppSPIRE.
Measured: Up to 4 months
The Stages of the Change Scale
A validated measure, The Stages of Change Scale, will be used to clarify smokers into 3 categories: pre-contemplation, contemplation and preparation.
Measured: Baseline up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study start16 Oct 2013
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alexander V Prokhorov, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967082
- Sponsor's protocol ID
- 2013-0369
- Other IDs
- NCI-2018-03054, 2013-0369, P30CA016672, R41DA035012
- Status last verified
- Jan 2020
- First submitted
- 16 Oct 2013
- Last updated
- 14 Jan 2020
- 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 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APPSPIRE: Expanding the Reach of an Innovative Tobacco Control Program for Youth
- ClinicalTrials.gov ID
- NCT01967082
- Acronym / sponsor ID
- 2013-0369
- Conditions
- Cigarette Smoker, Current Every Day Smoker, Student
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)
- Study start
- 16 Oct 2013 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 22 Oct 2013 (estimated)
- 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 APPSPIRE, a smartphone app, works in preventing students from smoking. Technology-driven intervention programs, such as the APPSPIRE app, have the potential to increase access to health behavior treatments and therapies, such as tobacco cessation support, and provide effective prevention messaging.
Detailed description
PRIMARY OBJECTIVES:
- Develop a prototype of the APPSPIRE (phone application [app] of a smoking prevention interactive experience).
II. At post assessment, students enrolled in the study will qualitatively provide information about the usability and usefulness for the prevention and cessation sites.
III. Investigate frequency of use of and exposure to APPSPIRE modules via an objective measure of general use.
IV. Investigate how feasible the program will be. V. Obtain a maintained use of APPSPIRE with high completeness and extent of completion.
VI. Evaluate change in stage of change from baseline to about 1 and 4-month follow-ups among participants.
OUTLINE:
Participants attend an audio-taped focus group over 1 hour and are given the APPSPIRE app. After 1 and 4 months of using the app, participants complete a telephone survey over 1 hour to discuss how they liked the app and its usefulness.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (focus group, APPSPIRE app, survey) | Experimental | Behavioral: APPSPIRE, Behavioral: Focus Group, Other: Survey AdministrationParticipants attend an audio-taped focus group over 1 hour and are given the APPSPIRE app. After 1 and 4 months of using the app, participants complete a telephone survey over 1 hour to discuss how they liked the app and its usefulness. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Student at Houston Community College (HCC)
- Speak and read English
- Own an iPhone
- Be enrolled in at least one class at HCC
- Provide current contact information
Key exclusion criteria (2 listed)
- Does not plan to continue as a student at their campus sometime during the year of the study (cessation and prevention/advocacy groups)
- Current tobacco use (prevention/advocacy group)
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 |
|---|---|---|
| APPSPIREAlso: APPSPIRE Smartphone Application; APPSPIRE Smartphone App; APPSPIRE App; APPSPIRE ApplicationGiven APPSPIRE app | Behavioural | Prevention (focus group, APPSPIRE app, survey) |
| Focus GroupAttend focus group | Behavioural | Prevention (focus group, APPSPIRE app, survey) |
| Survey AdministrationComplete survey | Other | Prevention (focus group, APPSPIRE app, survey) |
Primary outcome
Frequency of APPSPIRE application (app) use
Time frame: Up to 4 months
Will be measured in minutes per day and with descriptive statistics. Will measure using mean, median and standard deviation for continuous variables.
The Feasibility of the tobacco control program.
Time frame: Up to 4 months
Feasibly will be measured by multiplying the variable of two concepts: ease of use and ability to fit the program into routine schedules.
The Completeness with the Percentages of Participants surveyed.
Time frame: Up to 4 months
Completeness will be measured as the percentage of participants who continue to use AppSPIRE until the 4 month follow up survey.
The extent of completion for the modules AppSPIRE.
Time frame: Up to 4 months
The extent of completion includes the various modules of AppSPIRE. High extent of completion is obtained if 75% of the participants have completed all modules of AppSPIRE.
The Stages of the Change Scale
Time frame: Baseline up to 4 months
A validated measure, The Stages of Change Scale, will be used to clarify smokers into 3 categories: pre-contemplation, contemplation and preparation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- 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.
Alexander V Prokhorov principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APPSPIRE, Focus Group and Survey Administration in people with Cigarette Smoker and Current Every Day Smoker, run by M.D. Anderson Cancer Center 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 8 inclusion and 2 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 14 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of APPSPIRE application (app) use (time frame: Up to 4 months). The study lists 5 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 14 Jan 2020.