Tobacco Use Clinical Trial
— CanCEASEOfficial title:
Application of a Brief Digital Screening Tool to Address Parental and Adolescent Tobacco and Electronic Cigarette Use in Pediatric Medical Care (CanCEASE) - a Pilot Study
Verified date | February 2024 |
Source | St. Justine's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Tobacco use is the single greatest preventable cause of morbidity and mortality in Canada, accounting for 48,000 deaths and $16.2 billion annually in attributable health-related costs. Parents who smoke are often medically underserved and visit their child's doctor more than their own; 25% of all adult smokers have children seen in child healthcare. When parents quit smoking, their life expectancy is increased by more than 10 years, tobacco-related poor pregnancy outcomes are eliminated, children's risk of becoming smokers decreases 4-fold, families have more money for necessities, and children are less likely to suffer from diseases caused by tobacco smoke exposure. Despite free tobacco cessation services in every province and widespread insurance coverage of NRT, parental tobacco screening and cessation support rarely happens in pediatric care, thus there is potential for major health benefits from a routinely delivered tobacco control program to parents in this setting. The investigators will conduct a 12-month single centre, pragmatic, single-blind pilot RCT of CEASE vs. usual care of 70 parents who use cigarettes and/or vaping products whose children are seen in pediatric clinics at the CHU Sainte-Justine. A similar trial, CEASE-A will be conducted with 70 adolescents ages 14-17. Objectives: 1. Perform a pilot RCT of the Clinical Effort Against Secondhand Smoke (CEASE) intervention in Canada. CEASE is an evidence-based parental smoking cessation intervention to ensure that every parent who uses cigarettes and/or nicotine vaping products and visits their child's pediatrician receives nicotine dependence treatment 2. Conduct an ancillary pilot RCT of CEASE-A to deliver evidence-based support for adolescents who use tobacco and/or nicotine vaping products Outcomes include pilot process outcomes and preliminary effectiveness outcomes to assess feasibility and inform the preparation of a future large-scale RCT. This pilot RCT will provide the data necessary to plan a fully powered RCT assessing the effectiveness of CEASE and CEASE-A for smoking and vaping cessation.
Status | Active, not recruiting |
Enrollment | 130 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: - Parents or legal guardians of children 0-17 years old and who smoke or use nicotine vaping products. "User" will be defined as those who answer "Yes" to the screening questions: - "Have you smoked a single cigarette, even a puff, in the past 7 days?" (smoking); - "Have you used an e-cigarette or vaping device containing nicotine, even a puff, in the past 7 days? (vaping). For CEASE-A, adolescent patients aged 14-17 years who smoke or use nicotine vaping products will be considered. "Adolescent User" will be defined by those who answer "Yes" to the same screening question as parents. Parents will be eligible if 1) they are at least 18 years old, 2) their child is 0-17 years of age, 3) are attending a regular scheduled medical appointment, and 4) are sufficiently proficient in either French or English (able to read and answer a written questionnaire). Adolescents will be eligible if they are 14-17 years-old, meet criteria 3) and 4) above, and have provided informed consent (in Québec, adolescents aged 14 years can provide consent). Adolescents whose parent(s) (if present) are not agreeable to their participation will be excluded. Exclusion Criteria: - Families presenting to the clinic without a scheduled medical appointment will be excluded. There will be no other exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
Canada | Pediatric Clinic of the CHU Sainte-Justine | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
St. Justine's Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Parental and adolescent recruitment rates | The proportion of eligible participants approached who are enrolled in the study. Number of participants recruited per month. | 12 months of study follow up | |
Primary | Feasibility of the intervention | Proportion of eligible participants in each category (parents and adolescents) who declare interest in smoking/vaping cessation, who wish to be connected with smoking/vaping cessation services (quitlines), and who want to receive NRT. | 12 months of study follow up. | |
Primary | Protocol fidelity | Proportion of participants who complete the baseline questionnaire, proportion of participants who want to be connected to quitlines who are referred, and proportion who want to receive NRT and receive a prescription. | 6 months of participant follow up. | |
Primary | Study retention and completion of follow-up questionnaires | Proportion of participant that drop out or are lost to follow-up at 1, 3 and 6 months
Availability of self-reported smoking/vaping status at 1-, 3- and 6-month Complete data available (1-, 3- and 6-month surveys) for retained participants Availability of cotinine-testing at 1-, 3- and 6 months |
6 months of participant follow up. | |
Primary | Abstinence at 6 months | % of parental/adolescent users who report 7-day abstinence at 6-month follow-up. We will collect self-reported smoking and vaping status using the validated single items "Have you smoked a single cigarette, even a puff, in the past 7 days?" and "Have you used a nicotine vaping product, even a puff, in the past 7 days?" | 6 months of participant follow up. | |
Primary | Cotinine-confirmed quit | Participants who self-report 7-day abstinence at 1, 3 and/or 6 months will receive a sampling kit by mail along with instructions on how to collect the urine for biochemical confirmation of smoking/vaping cessation | 6 months of participant follow up. | |
Secondary | Proportion of participants reporting intent to quit smoking/vaping | Participant self-reported intention to quit smoking and/or vaping at recruitment and follow-up | 6 months of participant follow-up | |
Secondary | Proportion of participant reporting quit attempts at 1-, 3- and 6- months | Participant self-reported smoking or vaping cessation. | 6 months of participant follow-up |
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