CanCEASE + Health Navigator for Smoking Cessation

(CanCEASE-2 Trial)

Recruiting at 1 trial location

Overseen By Tamara Perez, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Urgent medical issue, No social risk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

1000 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation and social support, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment CanCEASE with Health Navigator for smoking cessation?

Research shows that patient navigation, which helps guide patients through healthcare processes, has been effective in improving adherence to treatments for chronic diseases and overcoming barriers to smoking cessation, especially among low-income and minority smokers. This suggests that using Health Navigator as part of the CanCEASE treatment could help more people successfully quit smoking. ^{1 2 3 4 5}

Is the CanCEASE + Health Navigator treatment safe for humans?

The studies on patient navigation for smoking cessation, including CanCEASE + Health Navigator, show that it is generally acceptable and feasible for participants, with no specific safety concerns reported in the research. ^{1 2 5 6 7}

What makes the CanCEASE + Health Navigator treatment unique for smoking cessation?

The CanCEASE + Health Navigator treatment is unique because it combines a community-based patient navigation approach with smoking cessation support, specifically targeting socioeconomically disadvantaged individuals who face more barriers to quitting smoking. This approach is designed to improve engagement and adherence to smoking cessation programs by providing personalized guidance and support, which is not typically offered in standard treatments. ^{2 5 8 9 10}

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.

Research Team

Nicholas Chadi, MD, MPH

Principal Investigator

CHU Sainte-Justine Research Centre

Olivier Drouin, MD, MSc, MPH

Principal Investigator

CHU Sainte-Justine Research Centre

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete the baseline questionnaire and initial evaluation with Health Navigator

4 weeks

1 visit (in-person or virtual)

Intervention

Participants in the intervention group receive CanCEASE and Health Navigator support, while control group receives care-as-usual

12 months

3 visits (in-person or virtual) at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for smoking cessation and resolution of social risks

12 months

2 visits (in-person or virtual) at 6 months and 12 months

Treatment Details

Interventions

• CanCEASE with Health Navigator

Trial Overview 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.

Participant Groups

Group I: CanCEASE with Health Navigator Experimental Treatment 1 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-usual Active Control 1 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).

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Findings from Research

A pilot study involving 40 socioeconomically disadvantaged smokers showed that using smoking cessation treatment navigators significantly increased the use of evidence-based cessation treatments, with 71% of participants starting nicotine replacement therapy.

The intervention was well-received, with high satisfaction ratings and a self-reported abstinence rate of 21%, suggesting that this community-based approach could effectively support smoking cessation efforts among low-income populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers. Levinson, AH., Valverde, P., Garrett, K., et al.[2023]

Continued smoking after a cancer diagnosis significantly increases the risk of mortality and second primary cancers, highlighting the importance of effective smoking cessation strategies for cancer patients.

In a study involving 134 current smokers identified from a cancer clinic, only 12 enrolled in a patient navigation intervention, with only 6 engaging in cessation treatment, indicating that while patients found the intervention satisfactory, the low recruitment rates suggest challenges in implementing this approach effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation-Based Smoking Cessation Program in Cancer Patients. Fan, T., Yingst, JM., Bascom, R., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Qualitative evaluation of a new tobacco cessation training curriculum for patient navigators. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Patient navigation to promote smoking cessation among low-income primary care patients: a pilot randomized controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A Novel Decision Aid to Encourage Smoking Cessation Among Patients at an Urban Safety Net Clinic. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Increasing Rates of Tobacco Treatment Delivery in Primary Care Practice: Evaluation of the Ottawa Model for Smoking Cessation. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Community-based navigators for tobacco cessation treatment: a proof-of-concept pilot study among low-income smokers. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation-Based Smoking Cessation Program in Cancer Patients. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Formative Provider Testing of a New Encounter Decision Aid for Smoking Cessation: Questionnaire Study. [2022]

8. Egypt pubmed.ncbi.nlm.nih.gov

Tobacco control and nicotine addiction in Canada: current trends, management and challenges. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A pre-post pilot study of a brief, web-based intervention to engage disadvantaged smokers into cessation treatment. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Challenges and Adaptations for Providing Smoking Cessation for Patients with Cancer across Canada during the COVID-19 Pandemic. [2023]