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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Aim 1 - 7-day abstinence
Timeframe: 6 months; 12 months
Aim 1 - Smoking intensity
Timeframe: 0 months; 6 months; 12 months
Aim 1 - Cotinine-confirmed quit
Timeframe: 6 months; 12 months
Aim 1 - Anabasine-confirmed quit
Timeframe: 6 months; 12 months
Aim 1 - Quit attempts
Timeframe: 6 months; 12 months
Aim 1 - Intent to quit
Timeframe: 0 months; 6 months; 12 months
Aim 2 - Resolution of social risk
Timeframe: 12 months
Aim 2 - Improvement in unmet social needs
Timeframe: 12 months
Aim 2 - Access to resources to help with unmet social needs
Melissa Nicolosi, B.A.
Timeframe: 12 months
Aim 3 - Interest in resources to help them quit
Timeframe: 0 months; 6 months; 12 months
Aim 3 - Meaningful receipt of assistance
Timeframe: 6 months; 12 months
Aim 3 - Proportion or participants who had contact with HNs
Timeframe: 12 months
Aim 3 - Number of sessions with heath navigators
Timeframe: 12 months
Aim 3 - Duration of sessions with heath navigators (in minutes)
Timeframe: 12 months
Aim 4 - Incremental cost-effectiveness ratio - intervention vs. usual care (from a healthcare system perspective)
Timeframe: Through study completion, an average of 1 year