NCT06651684 Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke
| NCT ID | NCT06651684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Justine's Hospital |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-03-26 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2026-03-26 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: The goal of this study is to address parental smoking and social adversity, which can present an obstacle for smoking cessation, in order to decrease childhood exposure to second-hand cigarette smoke. To address these factors, this study includes a smoking cessation intervention for parents and legal guardians recruited in pediatric clinics (CanCEASE), as well as the support of a Health Navigator (HN) to work with the participant towards the resolution or mitigation of unmet social needs. Participants: The research team will recruit one thousand participants from pediatric outpatient clinics within two healthcare centres in and around the city of Montreal, Canada, over the course of 2.5 years. Eligible persons are parents and legal guardians, of any sex and gender, accompanying children under 18 to their scheduled medical appointments, and who report at least one social risk in selected areas (i.e., employment, housing stability, ability to pay for utilities, financial resource strain, food security, transportation, childcare, parent education and health literacy). Participants must also be 18 years old or older with sufficient proficiency in French or English to complete the interviews and questionnaires. In households in which both parents smoke, only one will be eligible to participate, but smoking cessation information will be offered to both. Families presenting at the clinic for an urgent medical issue are not eligible to participate. Intervention: Participants will be divided into control group (care as usual with CanCEASE at the end of the study period) and intervention (CanCEASE + Health navigator). All participants will complete questionnaires at Baseline, 6 and 12 months. The intervention group will receive CanCEASE at the end of each questionnaire. Controls will receive CanCEASE at 12 months. The intervention group will have the possibility to meet with the HNs and will be invited to commit to at least two sessions (i.e.: evaluation and a follow up), with the option to book more time as needed. Aims and hypotheses: Examining how effective the combination of CanCEASE with HN support is in helping parents with unmet social needs quit smoking. Investigators will also examine the effects of the intervention on status of unmet social needs, if the intervention was implemented as planned and well accepted by clinics and participants, and what is the cost of the intervention for each person who quits smoking.
Eligibility Criteria
Inclusion Criteria: * Parents or legal guardians aged ≥18 years, with child(ren) aged 0-17 years, attending a regular scheduled medical appointment in one of the study sites. * Pregnant patients aged ≥18 years who are parents or legal guardians of child(ren) aged 0-17 years coming in for an prenatal appointment. * Smokers with at least one self-reported social risk as assessed by validated screening questions on the domains employment, housing stability, ability to pay for utilities, financial resource strain, food security, transportation, childcare, parent education and health literacy. * Sufficiently proficient in French or English to understand and complete study questionnaires. Exclusion Criteria: * Families presenting at the clinic for an urgent medical issue. * Parents without at least one social risk. * If both parents smoke, only one parent will be eligible to participate.
Contact & Investigator
Olivier Drouin, MD, MSc, MPH
PRINCIPAL INVESTIGATOR
CHU Sainte-Justine Research Centre
Frequently Asked Questions
Who can join the NCT06651684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06651684 currently recruiting?
Yes, NCT06651684 is actively recruiting participants. Contact the research team at melissa.nogueira.nicolosi.hsj@ssss.gouv.qc.ca for enrollment information.
Where is the NCT06651684 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06651684 clinical trial?
NCT06651684 is sponsored by St. Justine's Hospital. The principal investigator is Olivier Drouin, MD, MSc, MPH at CHU Sainte-Justine Research Centre. The trial plans to enroll 1,000 participants.