Tobacco Use CessationNCT03927976
Feasibility of a Culturally-Specific Video Text Cessation Intervention With AA Quitline Callers
A study testing Path2Quit - culturally specific text message intervention in people with Tobacco Use Cessation, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Assess the feasibility and acceptability of delivering an mHealth tobacco intervention among state quitline enrollees. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Path2Quit - culturally specific text message intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 10 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identify as African American
- Enrolled in state quitlines within the past 3 months
- Have access to SMS texting
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Testing the Feasibility of a Culturally-Specific Video Text Cessation Intervention With African American Quitline Callers
Assess the feasibility and acceptability of delivering an mHealth tobacco intervention among state quitline enrollees.
Read the detailed description
The main objective of this study is to assess the feasibility of delivering an mHealth tobacco intervention among state quitline enrollees. This will be measured through the assessment of interest and willingness to use the video text program, and the ability to receive video text messages (i.e., has technology capable of receiving and viewing video texts. At the end of the intervention, the team will assess satisfaction and perceived helpfulness of the video-text messaging program as an indication of acceptability.
- Conditions
- Tobacco Use Cessation
- Being tested
- Path2Quit - culturally specific text message intervention
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Path2Quit - culturally specific text message interventionBehavioural
SMS text delivers over 6 weeks with links to 20-120 second video clips from PTF. The message library contains 155 videos and assessment questions. First message is tailored to wake-up times, and the topic of the video (e.g., Never Quit Quitting) accompanies the text. Messages are pushed to participants 1-2 times/day, with 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP). Participants also receive inquiry texts, designed to push videos of interest/relevance to the individual. The cultural adaptations are 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 | After assessment eligibility, given consent, information about text messaging will be collected and participants enrolled in the Path2Quit culturally specific text message program and feedback will be collected on their experience. Receives: Behavioral: Path2Quit - culturally specific text message intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by interest in using Path2Quit video text program
The program will be evaluated as feasible if 50% of those screened are eligible and interested in the video text program AND if 90% of those who are eligible and interested in the video text program will be able to engage in the program (some may need technical assistance).
Measured: Through study completion, an average of 6-weeks.
Secondary outcomes (1)
Acceptability of intervention in terms of its Satisfaction and perceived helpfulness: 6-Week Follow-Up Questionnaire
Acceptability of intervention measured through a 6-Week Follow-Up Questionnaire assessing satisfaction with Path2Quit and perceived usefulness
Program will be evaluated as 'acceptable' if 80% of those who engage in the video text program and who answer the follow-up survey will rate their satisfaction with program and usefulness of the program at 3 or higher (on 0-7 scale where 3 indicates somewhat satisfied and somewhat useful) AND 80% rate the likelihood that they would recommend to a friend at a 3 or higher (on 0-7 point scale where 3 indicates "yes, I think so").
Measured: 6 weeks from end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start10 Apr 2019
- Primary completion30 Dec 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927976
- Sponsor's protocol ID
- CASE1Y19
- Status last verified
- Mar 2020
- First submitted
- 23 Apr 2019
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of a Culturally-Specific Video Text Cessation Intervention With African American Quitline Callers
- ClinicalTrials.gov ID
- NCT03927976
- Acronym / sponsor ID
- CASE1Y19
- Conditions
- Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 25 Apr 2019 (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.
Assess the feasibility and acceptability of delivering an mHealth tobacco intervention among state quitline enrollees.
Detailed description
The main objective of this study is to assess the feasibility of delivering an mHealth tobacco intervention among state quitline enrollees. This will be measured through the assessment of interest and willingness to use the video text program, and the ability to receive video text messages (i.e., has technology capable of receiving and viewing video texts. At the end of the intervention, the team will assess satisfaction and perceived helpfulness of the video-text messaging program as an indication of acceptability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Path2Quit | Experimental | Behavioral: Path2Quit - culturally specific text message interventionAfter assessment eligibility, given consent, information about text messaging will be collected and participants enrolled in the Path2Quit culturally specific text message program and feedback will be collected on their experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identify as African American
- Enrolled in state quitlines within the past 3 months
- Have access to SMS texting
Key exclusion criteria (1 listed)
- Does not meet 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 |
|---|---|---|
| Path2Quit - culturally specific text message interventionSMS text delivers over 6 weeks with links to 20-120 second video clips from PTF. The message library contains 155 videos and assessment questions. First message is tailored to wake-up times, and the topic of the video (e.g., Never Quit Quitting) accompanies the text. Messages are pushed to participants 1-2 times/day, with 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP). Participants also receive inquiry texts, designed to push videos of interest/relevance to the individual. The cultural adaptations are 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
Feasibility as measured by interest in using Path2Quit video text program
Time frame: Through study completion, an average of 6-weeks.
The program will be evaluated as feasible if 50% of those screened are eligible and interested in the video text program AND if 90% of those who are eligible and interested in the video text program will be able to engage in the program (some may need technical assistance).
1 secondary outcome
Acceptability of intervention in terms of its Satisfaction and perceived helpfulness: 6-Week Follow-Up Questionnaire
Time frame: 6 weeks from end of intervention
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 16 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Path2Quit - culturally specific text message intervention in people with Tobacco Use Cessation, 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 3 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 16 Mar 2020. 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?
Feasibility as measured by interest in using Path2Quit video text program (time frame: Through study completion, an average of 6-weeks.). 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 16 Mar 2020.