CanCEASE + Health Navigator for Smoking Cessation

(CanCEASE-2 Trial)

Not yet recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help parents quit smoking by addressing both their smoking habits and any social challenges, such as housing or financial issues. It compares usual care with an enhanced support system called CanCEASE with Health Navigator. This system includes a Health Navigator, trained to assist with quitting smoking and addressing other needs. The trial seeks parents or guardians who smoke, visit pediatric clinics with their children, and face at least one social risk, such as difficulty paying bills or finding stable housing. Participants will complete surveys throughout the study and may choose to meet with a Health Navigator for additional support. As an unphased trial, this study offers a unique opportunity to receive personalized support and resources to overcome smoking and social challenges.

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 prior data suggests that the CanCEASE with Health Navigator intervention is safe?

Research has shown that using a Health Navigator alongside smoking cessation tools is generally safe. In studies of similar programs, participants have not reported any serious side effects. The Health Navigator method has been used in other contexts to aid smoking cessation, with no evidence of harm.

One study demonstrated that this method helped more people quit smoking without causing major issues. The CanCEASE program, a digital tool, assists parents who smoke by assessing their readiness to quit and providing support. Combining this tool with the Health Navigator offers additional help to those facing social challenges, such as housing or financial difficulties, which might complicate smoking cessation.

Overall, this approach appears safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CanCEASE with Health Navigator program for smoking cessation because it offers a personalized approach unlike traditional methods, which often rely solely on Nicotine Replacement Therapy (NRT) and self-help resources. This program uniquely integrates support sessions with a Health Navigator—an individual with lived tobacco-related experience—who is trained to address unmet social needs and provide tailored guidance. This human-centered element could potentially enhance motivation and adherence, offering a promising alternative to the standard care options typically centered around medication and generic advice.

What evidence suggests that CanCEASE with Health Navigator is effective for smoking cessation?

This trial will compare the effectiveness of the CanCEASE program with Health Navigator support to care-as-usual for smoking cessation. Research has shown that using CanCEASE along with a Health Navigator can help people quit smoking. In previous studies, individuals with Health Navigator support were more likely to join smoking cessation programs. For instance, one study found that 47.4% of those with navigation support joined a treatment program, compared to 42.9% in the group without it. This finding suggests that guidance and support, especially from someone with similar experiences, can be more motivating. The CanCEASE program also assesses readiness to quit and provides helpful resources. Together, these tools aim to make quitting smoking easier, particularly for those facing social challenges. ^{1 2 6 7 8}

Who Is on the Research Team?

Olivier Drouin, MD, MSc, MPH

Principal Investigator

CHU Sainte-Justine Research Centre

Nicholas Chadi, MD, MPH

Principal Investigator

CHU Sainte-Justine Research Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06651684

NCT06651684 | Smoking Cessation Intervention Including ... CanCEASE is a digital intervention to identify parents who smoke, assess their motivation and willingness to quit, as well as to provide direct ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3827692/

Patient Navigation to Promote Smoking Cessation among Low ... 9/19 (47.4%) of navigation participants had engaged in smoking cessation treatment by three months versus 6/14 (42.9%) of control participants (chi-square p=NS) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6542736/

Process evaluation of counseling delivered by a patient ... This exploratory study examined the relationship between receipt of counseling by a patient navigator and socio-demographic characteristics ...

4. mdpi.com mdpi.com/1660-4601/19/7/4034

Feasibility of Patient Navigation-Based Smoking Cessation ... The primary study outcome was the feasibility of the patient navigation-based intervention; the secondary outcome was the engagement in smoking cessation ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656875/

Assessing the effects of Enhanced Multicomponent ... Estimates from our previous pilot studies of the TE intervention demonstrated improvements (47% vs 45%) among veterans [24] and (37% vs 15%) ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2659556

Effect of Patient Navigation and Financial Incentives on ... Among smokers at an urban safety-net hospital, navigation and incentives for smoking cessation significantly increased smoking cessation rates.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352853218302128

Process evaluation of counseling delivered by a patient ... This exploratory study examined the relationship between receipt of counseling by a patient navigator and socio-demographic characteristics of primary care ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5820724/

Effect of Patient Navigation and Financial Incentives on ... The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months. Results. Among 352 patients who were randomized (mean [SD] ...