SmokingPhase 2NCT01885052
Evaluation of National Cancer Institute Young Adult Stop-Smoking Program
A Phase 2 study testing QuitTXT Study and Low Contact in people with Smoking and Smoking Cessation, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Researchers want to see how well the QuitTXT text-message program helps smokers ages 18 29 stop smoking. This is part of a larger online stop-smoking program by the National Cancer Institute. The QuitTXT program is a 2-week countdown to the smoker s quit date with 6 weeks of follow-up messages. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation, Cigarette Smoking
- What is being tested?
- QuitTXT Study and Low Contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,432 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2013to 28 May 2015
- Phase
- Phase 2
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
- For this study, we will recruit smokers aged 18 to 29 who have smoked on at least 5 of the last 30 days and who are interested in stopping smoking in the next 30 days. To be eligible, a young adult must meet the following criteria:
Ages 18-29 years
Reside in the US
Smoke cigarettes at least 5 days/month
Be interested in quitting cigarette use
Not be involved in a cessation program
Have an active email account
Be able to receive text messages on their cell phone
Be the only member of your household participating in this study
Be willing to share contact information with the study team in order to share information about the study on a timely basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: NCI Young Adult Smoking Cessation Evaluation
Background:
- Researchers want to see how well the QuitTXT text-message program helps smokers ages 18 29 stop smoking. This is part of a larger online stop-smoking program by the National Cancer Institute. The QuitTXT program is a 2-week countdown to the smoker s quit date with 6 weeks of follow-up messages. Program participants will receive texts on their cell phones, including tips, information, and motivational messages, and then fill out surveys.
Read more
Objectives:
- To study how well the QuitTXT program helps smokers ages 18 29 stop smoking.
Eligibility:
- Adults ages 18 29 who have smoked on at least 5 of the past 30 days and who want to stop smoking in the next 30 days.
Design:
- Participants will receive a certain number of text messages during the 8-week study. They will receive between 0 to 5 messages per day (or up to a total of 130 messages).
- Participants will first fill out a survey about their smoking and quitting experiences. Then they will choose a date to quit smoking (a quit date ) between 2 and 3 weeks after this survey.
- Participants will take four other surveys online, one during the program and three more after they ve completed the program. Each survey will take about 10 20 minutes and asks about their smoking habits and views on smoking and quitting. Each survey will be sent by email, with reminders sent by email or telephone.
- Participants will receive an iTunes or Amazon gift card for completing each survey honestly.
Read the detailed description
This study seeks to assess the effectiveness of the QuitTXT program, a text message cessation intervention designed for young adult smokers ages 18-29. The QuitTXT program is a component of a larger web-based tobacco cessation intervention resource provided by the National Cancer Institute. The program focuses on providing actionable strategies and fact based information, serving as an engagement tool delivering two-way communication, and delivering intra- and extra-treatment support. The structure of the QuitTXT program is designed as a 14-day countdown to quit date with subsequent six weeks of messages. Throughout the program, users will receive texts that cover a variety of content areas including tips, informational content, motivational messaging, and keyword responses.
The study seeks to recruit a large sample of young adult smokers ages 18-29 to examine how exposure to the QuitTXT program affects participants.
There will be 3-arms to the study:
Participants in Arm 1, the control group of the study, will only receive the weekly assessments asking them of their smoking status.
Participants in Arm 2 will receive a texting program that consists of up to two weeks of countdown to quit messaging plus assessments messages that all groups receive for a total of 8 weeks.
Participants in Arm 3 will receive the full text messaging program.
All groups will be able to select a quit date within a 7-day window (between 2 and 3 weeks after they complete the baseline survey). Participants in Arm 3 will receive motivational/informational messages while participants in group 1 will receive only assessment messages. Participants in Arm 2 will receive the countdown messages to their quit date, but not the motivational messaging after their quit date. Like Arm 1, they will only receive assessment messages after their quit date.
This study will add unique value to the existing literature by teasing out the effect of some messages vs. frequent, motivational/informational messaging on quit rates and intent to quit among young adults.
- Conditions
- Smoking, Smoking Cessation, Cigarette Smoking, Tobacco, Smoking
- Being tested
- QuitTXT Study, Low Contact
- Keywords
- Smoking Cessation Clinical Trial, Text Messaging Program, Smoking Cessation Aid
- Medical subject headings
- Smoking, Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuitTXT StudyBehavioural
Assess the efficacy of a 6-8 week text message program to help young adults quit smoking.
Low ContactBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Receives weekly assessment messages ONLY Receives: Behavioral: Low Contact |
| 2 | Active comparator | Receives two week countdown messaging to quit date, and weekly assessment messages post quit date Receives: Behavioral: QuitTXT Study |
| 3 | Active comparator | Receives two week countdown messages to quit date, receives mulitiple messages per day post quit date with tips, encouragement and supportive messaging Receives: Behavioral: QuitTXT Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit smoking status
Measured: 1, 3, and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study start12 Jun 2013
- Primary completion12 Oct 2014
- Study completion28 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,432 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Erik M Augustson, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885052
- Sponsor's protocol ID
- 999913156
- Other IDs
- 13-C-N156
- Status last verified
- 27 Apr 2016
- First submitted
- 20 Jun 2013
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.
PubMed 19917951Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
PubMed 10842426Baer JS, Lichtenstein E. Classification and prediction of smoking relapse episodes: an exploration of individual differences. J Consult Clin Psychol. 1988 Feb;56(1):104-10. doi: 10.1037//0022-006x.56.1.104. No abstract available.
PubMed 3346434Squiers L, Brown D, Parvanta S, Dolina S, Kelly B, Dever J, Southwell BG, Sanders A, Augustson E. The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults. JMIR Res Protoc. 2016 Jun 27;5(2):e134. doi: 10.2196/resprot.5653.
PubMed 27349898
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NCI Young Adult Smoking Cessation Evaluation
- ClinicalTrials.gov ID
- NCT01885052
- Acronym / sponsor ID
- 999913156
- Conditions
- Smoking, Smoking Cessation, Cigarette Smoking, Tobacco, Smoking
- Keywords
- Smoking Cessation Clinical Trial, Text Messaging Program, Smoking Cessation Aid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,432 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Jun 2013
- Primary completion
- 12 Oct 2014 (actual)
- Study completion
- 28 May 2015 (actual)
- First posted
- 24 Jun 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.
Background:
- Researchers want to see how well the QuitTXT text-message program helps smokers ages 18 29 stop smoking. This is part of a larger online stop-smoking program by the National Cancer Institute. The QuitTXT program is a 2-week countdown to the smoker s quit date with 6 weeks of follow-up messages. Program participants will receive texts on their cell phones, including tips, information, and motivational messages, and then fill out surveys.
Objectives:
- To study how well the QuitTXT program helps smokers ages 18 29 stop smoking.
Eligibility:
- Adults ages 18 29 who have smoked on at least 5 of the past 30 days and who want to stop smoking in the next 30 days.
Design:
- Participants will receive a certain number of text messages during the 8-week study. They will receive between 0 to 5 messages per day (or up to a total of 130 messages).
- Participants will first fill out a survey about their smoking and quitting experiences. Then they will choose a date to quit smoking (a quit date ) between 2 and 3 weeks after this survey.
- Participants will take four other surveys online, one during the program and three more after they ve completed the program. Each survey will take about 10 20 minutes and asks about their smoking habits and views on smoking and quitting. Each survey will be sent by email, with reminders sent by email or telephone.
- Participants will receive an iTunes or Amazon gift card for completing each survey honestly.
Detailed description
This study seeks to assess the effectiveness of the QuitTXT program, a text message cessation intervention designed for young adult smokers ages 18-29. The QuitTXT program is a component of a larger web-based tobacco cessation intervention resource provided by the National Cancer Institute. The program focuses on providing actionable strategies and fact based information, serving as an engagement tool delivering two-way communication, and delivering intra- and extra-treatment support. The structure of the QuitTXT program is designed as a 14-day countdown to quit date with subsequent six weeks of messages. Throughout the program, users will receive texts that cover a variety of content areas including tips, informational content, motivational messaging, and keyword responses.
The study seeks to recruit a large sample of young adult smokers ages 18-29 to examine how exposure to the QuitTXT program affects participants.
There will be 3-arms to the study:
Participants in Arm 1, the control group of the study, will only receive the weekly assessments asking them of their smoking status.
Participants in Arm 2 will receive a texting program that consists of up to two weeks of countdown to quit messaging plus assessments messages that all groups receive for a total of 8 weeks.
Participants in Arm 3 will receive the full text messaging program.
All groups will be able to select a quit date within a 7-day window (between 2 and 3 weeks after they complete the baseline survey). Participants in Arm 3 will receive motivational/informational messages while participants in group 1 will receive only assessment messages. Participants in Arm 2 will receive the countdown messages to their quit date, but not the motivational messaging after their quit date. Like Arm 1, they will only receive assessment messages after their quit date.
This study will add unique value to the existing literature by teasing out the effect of some messages vs. frequent, motivational/informational messaging on quit rates and intent to quit among young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Behavioral: Low ContactReceives weekly assessment messages ONLY |
| 2 | Active comparator | Behavioral: QuitTXT StudyReceives two week countdown messaging to quit date, and weekly assessment messages post quit date |
| 3 | Active comparator | Behavioral: QuitTXT StudyReceives two week countdown messages to quit date, receives mulitiple messages per day post quit date with tips, encouragement and supportive messaging |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| QuitTXT StudyAssess the efficacy of a 6-8 week text message program to help young adults quit smoking. | Behavioural | 2, 3 |
| Low Contact | Behavioural | 1 |
Primary outcome
Quit smoking status
Time frame: 1, 3, and 6 month follow up
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 9 Dec 2019.
- Background: PubMed 19917951Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.
- Background: PubMed 10842426Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
- Background: PubMed 3346434Baer JS, Lichtenstein E. Classification and prediction of smoking relapse episodes: an exploration of individual differences. J Consult Clin Psychol. 1988 Feb;56(1):104-10. doi: 10.1037//0022-006x.56.1.104. No abstract available.
- Derived from this study: PubMed 27349898Squiers L, Brown D, Parvanta S, Dolina S, Kelly B, Dever J, Southwell BG, Sanders A, Augustson E. The SmokefreeTXT (SFTXT) Study: Web and Mobile Data Collection to Evaluate Smoking Cessation for Young Adults. JMIR Res Protoc. 2016 Jun 27;5(2):e134. doi: 10.2196/resprot.5653.
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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.
Erik M Augustson, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QuitTXT Study and Low Contact in people with Smoking and Smoking Cessation, run by National Cancer Institute (NCI) 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?
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 9 Dec 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quit smoking status (time frame: 1, 3, and 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01885052, which also lists 4 linked publications.
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 9 Dec 2019.