Recruiting

CanCEASE with HN

Sponsor:

St. Justine's Hospital

Code:

NCT06651684

Conditions

Smoking Cessation

Tobacco Dependence

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CanCEASE with Health Navigator

Study Details

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.

Conditions

Smoking Cessation

Tobacco Dependence

Study ID

NCT06651684

Start date

Mar 26, 2026

Status verified date

Jul, 2026

Completion date

Feb, 2030

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Care-as-usual

Participants assigned to this group will receive care as usually delivered in participating clinics and list of smoking cessation resources, including instructions to access Nicotine Replacement Therapy (NRT).

experimental: CanCEASE with Health Navigator

Participants assigned to this arm will receive smoking cessation resources, including instructions to access Nicotine Replacement Therapy (NRT) at Baseline, 6 and 12 months. They will also have the choice to schedule support sessions with a Health Navigator, which will be an individual with lived experience related to tobacco and trained to provide support for unmet social needs.

Interventions

CanCEASE with Health Navigator

CanCEASE is a digital intervention to identify parents who smoke, assess their motivation and willingness to quit, as well as to provide direct linkage to evidence-based smoking interventions, including effective behavioural and pharmacological resources that can be used alone or in combination.

Participants will have the choice to receive CanCEASE at three timepoints (0, 6 and 12 months). CanCEASE will be combined with an offer of support sessions with a Health Navigator.

Health Navigators will be research personnel hired specifically for this study and trained formally in health navigation, tobacco cessation counseling and strategies to address unmet social needs. The investigators will leverage knowledge and experience of two ongoing RCTs of HNs in pediatrics to inform training strategies.

Primary outcome measure

  • Aim 1 - 7-day abstinence [ Time Frame: 6 months; 12 months ]
  • Aim 1 - Smoking intensity [ Time Frame: 0 months; 6 months; 12 months ]
  • Aim 1 - Cotinine-confirmed quit [ Time Frame: 6 months; 12 months ]
  • Aim 1 - Anabasine-confirmed quit [ Time Frame: 6 months; 12 months ]
  • Aim 1 - Quit attempts [ Time Frame: 6 months; 12 months ]
  • Aim 1 - Intent to quit [ Time Frame: 0 months; 6 months; 12 months ]
  • Aim 2 - Resolution of social risk [ Time Frame: 12 months ]
  • Aim 2 - Improvement in unmet social needs [ Time Frame: 12 months ]
  • Aim 2 - Access to resources to help with unmet social needs [ Time Frame: 12 months ]
  • Aim 3 - Interest in resources to help them quit [ Time Frame: 0 months; 6 months; 12 months ]
  • Aim 3 - Meaningful receipt of assistance [ Time Frame: 6 months; 12 months ]
  • Aim 3 - Proportion or participants who had contact with HNs [ Time Frame: 12 months ]
  • Aim 3 - Number of sessions with heath navigators [ Time Frame: 12 months ]
  • Aim 3 - Duration of sessions with heath navigators (in minutes) [ Time Frame: 12 months ]
  • Aim 4 - Incremental cost-effectiveness ratio - intervention vs. usual care (from a healthcare system perspective) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Locations

Maisonneuve-Rosemont Hospital

Recruiting

Montreal, Quebec, Canada, H1T 2M4

Contacts

Pediatric Clinic of the CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T1C5

Contacts

Olivier Drouin, MD, MPH, MSc

514 345-4931o.drouin@umontreal.ca

Nicholas Chadi, MDCM, MPH

nicholas.chadi.med@ssss.gouv.qc

Pierre-Le Gardeur Hospital

Recruiting

Montreal, Quebec, Canada, J6V 0E8

Contacts

More Information

Sponsor

St. Justine's Hospital

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Smoking cessation
  • Social risk
  • Second hand smoke
  • Health navigator
  • Unmet social needs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2026-07-24.