CanCEASE + Health Navigator for Smoking Cessation
(CanCEASE-2 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byOlivier Drouin, MD, MSc, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: St. Justine's Hospital

No Placebo Group

Trial Summary

What is the purpose of 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 is for parents or legal guardians who smoke, are over 18 years old, and accompany a child under 18 to pediatric clinics in Montreal. They must face at least one social challenge like job security or food access and speak French or English well enough for interviews.

Inclusion Criteria

I can understand and complete questionnaires in English or French.

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

I am over 18 and have a child under 18 seeing a doctor at the study site.

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.

Participant Groups

The study tests a smoking cessation program called CanCEASE with added Health Navigator support against usual care. Participants will be split into two groups: one receives the intervention immediately, while the other gets it after a year, with follow-ups at 6 and 12 months.

2Treatment groups

Experimental Treatment

Active Control

Group I: CanCEASE with Health NavigatorExperimental Treatment1 Intervention

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.

Group II: Care-as-usualActive Control1 Intervention

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).