Smoking CessationNCT03524482
Path2Quit Tobacco Intervention For African Americans
A study testing SmokeFreeText and Path2Quit in people with Smoking Cessation and Smoking, Tobacco, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program. The study includes completing surveys and receiving text messages to help participants become tobacco free. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking, Tobacco
- What is being tested?
- SmokeFreeText and Path2Quit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 20 Aug 2018
- 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
- Self-identify as African American
- Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm
- Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days.
- Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines
Who cannot join
- Does not meet all of the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans
The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.
The study includes completing surveys and receiving text messages to help participants become tobacco free.
Read the detailed description
OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format.
Specific Aim 2: Conduct a pilot study of the video-text intervention.
Study Design:
2-arm semi-pragmatic randomized design among current tobacco users
Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.
- Conditions
- Smoking Cessation, Smoking, Tobacco
- Being tested
- SmokeFreeText, Path2Quit
- Keywords
- culturally specific
- Medical subject headings
- Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokeFreeTextBehavioural
Also called SmokefreeTXT
SmokefreeTXT is a 6-8 week fully automated text-based cessation intervention. The program is free to U.S. subscribers who have a mobile phone, and is available on smokefree.gov or by texting "QUIT" to short code 47848. Participants are encouraged to set a quit date within the next 14 days, followed by count-down messages leading to the quit date. Starting on the quit date, participants receive 6 weeks of intervention text messages, and assessment questions (mood, cravings, smoking status). The message library contains 166 messages and 41 behavior change techniques,40 which are delivered at the greatest frequency during the first 2 weeks and taper over time. When in need of assistance, participants can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system. Participants can opt-out by texting STOP at any time. With informed consent, we will be able to access the SmokefreeTXT data for these participants.
Path2QuitBehavioural
Path2Quit will deliver 20-60 second video clips by multimedia messaging service. The message library will include 75-170 messages. Written text messages will be limited to brief phrases to indicate the topic of the video. Messages will be pushed to participants in the morning, in the afternoon, and 2 hours before the reported usual bedtime. The cultural adaptations will be infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.
| Study group | Role | What they receive |
|---|---|---|
| Path2Quit | Experimental | Culturally specific text message intervention Receives: Behavioral: Path2Quit |
| SmokeFreeText | Active comparator | The National Cancer Institute's publicly available, standard text messaging program for tobacco cessation Receives: Behavioral: SmokeFreeText |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who abstain from smoking
Abstinence will be coded as a binary variable. Analysis will be conducted with an intent to treat approach
Measured: At 1-month follow-up
Secondary outcomes (6)
Number of missed nicotine replacement therapy doses
Measure of NRT adherence. Number of missed doses will be recorded for each participant
Measured: Up to 1-month follow-up
24-Hour quit attempts
Number of times a participant quits smoking for at least 24 hours
Measured: At 1-month follow-up
Changes in carbon monoxide breath levels from baseline to followup
Breath carbon monoxide tests will biochemically confirm self-reported cessation
Measured: At 1-month follow-up
Changes in Contemplation ladder score
self-reported score 0-10 where a higher score indicates more readiness to quit
Measured: From baseline to up to 1-month follow-up
Average score of Intervention Evaluation (IRQ)
The IRQ is a 22 item scale scored 0-7 (total score 0-154) where higher scores indicate more satisfaction
Measured: At 1-month follow-up
Average score of smoking urges
This brief, 10 item scale is scores 1-7 (total score 10-70) with higher scores indicating greater agreement
Measured: Up to 1-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 posted14 May 2018
- Study start1 Apr 2018
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will conduct a 2-arm semi-pragmatic randomized design among current tobacco users (N=100). CMHA residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT).
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Webb Hooper, PhD, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524482
- Sponsor's protocol ID
- CASE1Y18
- Status last verified
- Mar 2019
- First submitted
- 30 Apr 2018
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Webb Hooper M, Miller DB, Saldivar E, Mitchell C, Johnson L, Burns M, Huang MC. Randomized controlled trial testing a video-text tobacco cessation intervention among economically disadvantaged African American adults. Psychol Addict Behav. 2021 Nov;35(7):769-777. doi: 10.1037/adb0000691. Epub 2021 Oct 14.
PubMed 34647777
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans
- ClinicalTrials.gov ID
- NCT03524482
- Acronym / sponsor ID
- CASE1Y18
- Conditions
- Smoking Cessation, Smoking, Tobacco
- Keywords
- culturally specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 14 May 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.
The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.
The study includes completing surveys and receiving text messages to help participants become tobacco free.
Detailed description
OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format.
Specific Aim 2: Conduct a pilot study of the video-text intervention.
Study Design:
2-arm semi-pragmatic randomized design among current tobacco users
Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We will conduct a 2-arm semi-pragmatic randomized design among current tobacco users (N=100). CMHA residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT).
| Arm | Type | Receives |
|---|---|---|
| Path2Quit | Experimental | Behavioral: Path2QuitCulturally specific text message intervention |
| SmokeFreeText | Active comparator | Behavioral: SmokeFreeTextThe National Cancer Institute's publicly available, standard text messaging program for tobacco cessation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as African American
- Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm
- Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days.
- Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines
Key exclusion criteria (1 listed)
- Does not meet all of the above inclusion criteria
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 |
|---|---|---|
| SmokeFreeTextAlso: SmokefreeTXTSmokefreeTXT is a 6-8 week fully automated text-based cessation intervention. The program is free to U.S. subscribers who have a mobile phone, and is available on smokefree.gov or by texting "QUIT" to short code 47848. Participants are encouraged to set a quit date within the next 14 days, followed by count-down messages leading to the quit date. Starting on the quit date, participants receive 6 weeks of intervention text messages, and assessment questions (mood, cravings, smoking status). The message library contains 166 messages and 41 behavior change techniques,40 which are delivered at the greatest frequency during the first 2 weeks and taper over time. When in need of assistance, participants can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system. Participants can opt-out by texting STOP at any time. With informed consent, we will be able to access the SmokefreeTXT data for these participants. | Behavioural | SmokeFreeText |
| Path2QuitPath2Quit will deliver 20-60 second video clips by multimedia messaging service. The message library will include 75-170 messages. Written text messages will be limited to brief phrases to indicate the topic of the video. Messages will be pushed to participants in the morning, in the afternoon, and 2 hours before the reported usual bedtime. The cultural adaptations will be infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry. | Behavioural | Path2Quit |
Primary outcome
Proportion of participants who abstain from smoking
Time frame: At 1-month follow-up
Abstinence will be coded as a binary variable. Analysis will be conducted with an intent to treat approach
6 secondary outcomes
Number of missed nicotine replacement therapy doses
Time frame: Up to 1-month follow-up
24-Hour quit attempts
Time frame: At 1-month follow-up
Changes in carbon monoxide breath levels from baseline to followup
Time frame: At 1-month follow-up
Changes in Contemplation ladder score
Time frame: From baseline to up to 1-month follow-up
Average score of Intervention Evaluation (IRQ)
Time frame: At 1-month follow-up
Average score of smoking urges
Time frame: Up to 1-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 28 Mar 2019.
- Derived from this study: PubMed 34647777Webb Hooper M, Miller DB, Saldivar E, Mitchell C, Johnson L, Burns M, Huang MC. Randomized controlled trial testing a video-text tobacco cessation intervention among economically disadvantaged African American adults. Psychol Addict Behav. 2021 Nov;35(7):769-777. doi: 10.1037/adb0000691. Epub 2021 Oct 14.
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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.
Monica Webb Hooper, PhD principal investigator
Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmokeFreeText and Path2Quit in people with Smoking Cessation and Smoking, Tobacco, run by Case Comprehensive Cancer Center 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?
The sponsor lists 4 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 28 Mar 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. 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?
Proportion of participants who abstain from smoking (time frame: At 1-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 NCT03524482, which also lists 1 linked publication.
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 28 Mar 2019; AzTrials last refreshed its copy on 2 Nov 2026.