Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Justine's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CanCEASE with Health Navigator

    Behavioral

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Care-as-usualNo intervention 0 interventions
Group B: CanCEASE with Health NavigatorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Aim 1 - 7-day abstinence

Percentage of participants who self-report 7-day abstinence

Time frame
6 months; 12 months
2

Aim 1 - Smoking intensity

Average self-reported number of cigarettes per day.

Time frame
0 months; 6 months; 12 months
3

Aim 1 - Cotinine-confirmed quit

Urinary cotinine values below 100 ng/ml, a consensus cutoff level, biochemical confirmation of 7-day abstinence.

Time frame
6 months; 12 months
4

Aim 1 - Anabasine-confirmed quit

Urinary anabasine detection allows for the differentiation between smokers and abstainers who are using NRT at concentrations below 1.2 ng/mL.

Time frame
6 months; 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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