SmokingNCT03038542
Quit4hlth: Enhancing Tobacco and Cancer Control Through Framed Text Messages
A study testing Gain-framed text messages in people with Smoking, run by Medical University of South Carolina.
Trial summary
This study evaluates a text messaging intervention through a smokers' quitline. Smokers will either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored, standard care text messages, both combined with standard quitline treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Gain-framed text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Oct 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) call the Quitline requesting assistance with quitting smoking, 2) be 18+ years old, 3) speak English, 4) have a verified New York address, and 5) opt into the standard Quitline texting protocol.
Who cannot join
- -
About this study
This study evaluates a text messaging intervention through a smokers' quitline. Smokers will either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored, standard care text messages, both combined with standard quitline treatment. We hypothesize that the gain-framed text message intervention will increase cessation rates at 30 weeks as compared to standard care text messages.
- Conditions
- Smoking
- Being tested
- Gain-framed text messages, Standard care text messages
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gain-framed text messagesBehavioural
Standard care text messagesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment Text Arm | Experimental | Not described Receives: Behavioral: Gain-framed text messages |
| Standard Text Arm | Active comparator | Not described Receives: Behavioral: Standard care text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
survey of smoking status
smoking or abstinent
Measured: Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Roswell Park Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Benjamin Toll, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038542
- Sponsor's protocol ID
- Pro00044521
- Status last verified
- Jul 2018
- First submitted
- 30 Jan 2017
- Last updated
- 17 Jul 2018
- 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 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quit4hlth: Enhancing Tobacco and Cancer Control Through Framed Text Messages
- ClinicalTrials.gov ID
- NCT03038542
- Acronym / sponsor ID
- Pro00044521
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Roswell Park Cancer Institute
- Study start
- May 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 31 Jan 2017 (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 study evaluates a text messaging intervention through a smokers' quitline. Smokers will either receive 30 weeks of tailored, gain-framed text messages or 30 weeks of tailored, standard care text messages, both combined with standard quitline treatment. We hypothesize that the gain-framed text message intervention will increase cessation rates at 30 weeks as compared to standard care text messages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Text Arm | Experimental | Behavioral: Gain-framed text messages |
| Standard Text Arm | Active comparator | Behavioral: Standard care text messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) call the Quitline requesting assistance with quitting smoking, 2) be 18+ years old, 3) speak English, 4) have a verified New York address, and 5) opt into the standard Quitline texting protocol.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Gain-framed text messages | Behavioural | Treatment Text Arm |
| Standard care text messages | Behavioural | Standard Text Arm |
Primary outcome
survey of smoking status
Time frame: Week 30
smoking or abstinent
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 17 Jul 2018.
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, 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.
Benjamin Toll, PhD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing Gain-framed text messages in people with Smoking, run by Medical University of South Carolina.
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 1 inclusion and 1 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 17 Jul 2018. 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 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?
survey of smoking status (time frame: Week 30). 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 17 Jul 2018.