Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR160334645 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Massachusetts, Amherst | OTHER |
| Northwestern University | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
The research study, "Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions" will test two smoker-driven, social marketing innovations to recruit and engage smokers in Decide2Quit.org (Decide2Quit), which is an evidence-based, effective "Digital Intervention for Smoking Cessation".
S2S has many innovations that are designed to utilize the power of peers and social networks for dissemination. These include: Peer recruitment: Tools to facilitate smokers' recruiting their peers to increase Decide2Quit access; and a recommender computer tailored health communication (recommender CTHC): a Complex machine learning algorithm (recommender systems) that uses smokers' feedback (explicit and implicit) in the current and prior studies to adapt its selection of messages to smokers.
Using a 2×2 factorial design, the study will compare individually and collectively the enhancements (recruitment, use, and effectiveness) offered by the S2S functions over the standard version of Decide2Quit (online recruitment and standard CTHC), an active comparison group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fully enhanced | Experimental | Peer recruitment and recommender CTHC |
|
| Recommender CTHC only | Experimental | Recommender CTHC and standard online recruitment |
|
| Peer recruitment only | Experimental | Peer recruitment and standard CTHC |
|
| Standard | Experimental | Standard online recruitment and standard CTHC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recommender CTHC | Behavioral | Enhanced Messaging |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation | Smoking cessation measured by the 7-day point prevalence question: Six month, 7-day point prevalence : Do you currently smoke cigarettes (smoked even 1 puff in the last 7 days)?
| At 6 months post registration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Cigarettes Smoked | Calculated as: number of cigarettes smoked at six months minus the number of number of cigarettes smoked at baseline. | At 6 months post registration |
| Repeated Use of Decide2Quit Functions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rajani Sadasivam, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39334264 | Derived | Lee DN, Faro JM, Stevens EM, Pbert L, Yang C, Sadasivam RS. Stopping use of E-cigarettes and smoking combustible cigarettes: findings from a large longitudinal digital smoking cessation intervention study in the United States. BMC Res Notes. 2024 Sep 27;17(1):276. doi: 10.1186/s13104-024-06939-w. | |
| 36633844 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fully Enhanced | Peer recruitment and recommender CTHC Recommender CTHC: Enhanced Messaging Peer Recruitment: Tools to facilitate smokers' recruiting their peers |
| FG001 | Recommender CTHC Only | Recommender CTHC and standard online recruitment Recommender CTHC: Enhanced Messaging Standard Online Recruitment: Search Engine and Social Media Advertisements |
| FG002 | Peer Recruitment Only | Peer recruitment and standard CTHC Standard CTHC: Standard Messaging Peer Recruitment: Tools to facilitate smokers' recruiting their peers |
| FG003 | Standard | Standard online recruitment and standard CTHC Standard CTHC: Standard Messaging Standard Online Recruitment: Search Engine and Social Media Advertisements |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fully Enhanced | Peer recruitment and recommender CTHC Recommender CTHC: Enhanced Messaging Peer Recruitment: Tools to facilitate smokers' recruiting their peers |
| BG001 | Recommender CTHC Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Cessation | Smoking cessation measured by the 7-day point prevalence question: Six month, 7-day point prevalence : Do you currently smoke cigarettes (smoked even 1 puff in the last 7 days)?
| Posted | Count of Participants | Participants | At 6 months post registration |
|
Not provided
Our study was an anonymous online smoking cessation intervention there were no risks to participants physical health associated with Decide2Quit. There was no possibility or risk for mortality associated with participation in our study. All-Cause Mortality, Serious, and Other (not including serious) Adverse Events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fully Enhanced | Peer recruitment and recommender CTHC Recommender CTHC: Enhanced Messaging Peer Recruitment: Tools to facilitate smokers' recruiting their peers |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajani Sadasivam | University of Massachusetts Medical School | 508-856-8923 | rajani.sadasivam@umassmed.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2019 | Jan 22, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
Using a 2×2 factorial design, we will compare individually and collectively the enhancements (recruitment, use, and effectiveness) offered by the S2S functions over the standard version of Decide2Quit (online recruitment and standard CTHC), an active comparison group that was demonstrated to be effective in our previous trial.
Not provided
Not provided
Not provided
| Standard CTHC |
| Behavioral |
Standard Messaging |
|
| Peer Recruitment | Other | Tools to facilitate smokers' recruiting their peers |
|
| Standard Online Recruitment | Other | Search Engine and Social Media Advertisements |
|
As measured by, an ordinal scale of number of Decide2Quit functions used after the first DISC visit (0: no functions used; 1: use of 1-2 functions, 2: > 2 functions used).
| Throughout study (tracked for 6 months post registration) |
| Recruitment of African Americans | This is measured by the proportion of African Americans in each treatment arm | At Baseline Registration |
| Recruitment Time | Calculated as: each individual participant's recruitment date minus the date of the first participant's registration. Based on this formula, the first participant will have a recruitment time of 0 days and the last participant could have a maximum recruitment time of 3 years (1095 days). | At Baseline Registration |
| Faro JM, Chen J, Flahive J, Nagawa CS, Orvek EA, Houston TK, Allison JJ, Person SD, Smith BM, Blok AC, Sadasivam RS. Effect of a Machine Learning Recommender System and Viral Peer Marketing Intervention on Smoking Cessation: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250665. doi: 10.1001/jamanetworkopen.2022.50665. |
| 34563161 | Derived | Chen J, Houston TK, Faro JM, Nagawa CS, Orvek EA, Blok AC, Allison JJ, Person SD, Smith BM, Sadasivam RS. Evaluating the use of a recommender system for selecting optimal messages for smoking cessation: patterns and effects of user-system engagement. BMC Public Health. 2021 Sep 26;21(1):1749. doi: 10.1186/s12889-021-11803-8. |
| 33571687 | Derived | Faro JM, Nagawa CS, Orvek EA, Smith BM, Blok AC, Houston TK, Kamberi A, Allison JJ, Person SD, Sadasivam RS. Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov. Contemp Clin Trials. 2021 Apr;103:106314. doi: 10.1016/j.cct.2021.106314. Epub 2021 Feb 8. |
Recommender CTHC and standard online recruitment
Recommender CTHC: Enhanced Messaging
Standard Online Recruitment: Search Engine and Social Media Advertisements
| BG002 | Peer Recruitment Only | Peer recruitment and standard CTHC Standard CTHC: Standard Messaging Peer Recruitment: Tools to facilitate smokers' recruiting their peers |
| BG003 | Standard | Standard online recruitment and standard CTHC Standard CTHC: Standard Messaging Standard Online Recruitment: Search Engine and Social Media Advertisements |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Cigarettes Smoked per day | Count of Participants | Participants |
|
| Smoking Status | Count of Participants | Participants |
|
| OG002 | Peer Recruitment Only | Peer recruitment and standard CTHC Standard CTHC: Standard Messaging Peer Recruitment: Tools to facilitate smokers' recruiting their peers |
| OG003 | Standard | Standard online recruitment and standard CTHC Standard CTHC: Standard Messaging Standard Online Recruitment: Search Engine and Social Media Advertisements |
|
|
| Secondary | Change in the Number of Cigarettes Smoked | Calculated as: number of cigarettes smoked at six months minus the number of number of cigarettes smoked at baseline. | Posted | Mean | Standard Deviation | cigarettes a day | At 6 months post registration |
|
|
|
| Secondary | Repeated Use of Decide2Quit Functions | As measured by, an ordinal scale of number of Decide2Quit functions used after the first DISC visit (0: no functions used; 1: use of 1-2 functions, 2: > 2 functions used). | Analysis population limited to participants who visited Decide2Quit more than one time. | Posted | Count of Participants | Participants | Throughout study (tracked for 6 months post registration) |
|
|
|
| Secondary | Recruitment of African Americans | This is measured by the proportion of African Americans in each treatment arm | Posted | Count of Participants | Participants | At Baseline Registration |
|
|
|
| Secondary | Recruitment Time | Calculated as: each individual participant's recruitment date minus the date of the first participant's registration. Based on this formula, the first participant will have a recruitment time of 0 days and the last participant could have a maximum recruitment time of 3 years (1095 days). | Posted | Mean | Standard Deviation | days | At Baseline Registration |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Recommender CTHC Only | Recommender CTHC and standard online recruitment Recommender CTHC: Enhanced Messaging Standard Online Recruitment: Search Engine and Social Media Advertisements | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Peer Recruitment Only | Peer recruitment and standard CTHC Standard CTHC: Standard Messaging Peer Recruitment: Tools to facilitate smokers' recruiting their peers | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Standard | Standard online recruitment and standard CTHC Standard CTHC: Standard Messaging Standard Online Recruitment: Search Engine and Social Media Advertisements | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| 1 or 2 Functions Used |
|
| Greater than 2 Functions Used |
|