NCT07548788Not yet recruiting
A Lay Navigation Intervention for Patients With Lung Cancer
Feasibility and Acceptability of the Care and Connect Program for Patients With Lung Cancer
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
Background: In Canada, lung cancer accounts for approximately 25% of cancer deaths each year. There are also known sociodemographic and racial inequities in the diagnosis and treatment of lung cancer. Studies have consistently found that patients with cancer have a high number of unmet needs, including psychological, physical, and informational. Navigation programs represent a potentially promising, equitable, and cost-effective approach to address the unmet needs of patients with lung cancer, but there is limited evidence about their effectiveness in patients with lung cancer. The investigators developed and have implemented a volunteer lay navigator program, Care and Connect (C\&C), which aims to proactively reduce distress in patients, provide information and support, and increase access to treatment and supportive care resources. The proposed pilot randomized controlled trial (RCT) project plans to 1) assess the feasibility and acceptability of referral to C\&C and, 2) examine the preliminary effectiveness of C\&C. Methods: The current study is a 2-arm, parallel group, mixed methods, pilot RCT with a 1:1 allocation ratio and 3 timepoints: baseline (T0), 3 months (T1), 6 months (T2). It is designed to test the trial feasibility and acceptability of the C\&C intervention in patients with lung cancer. In total, 50 participants will be randomized to receive the C\&C intervention or usual care only (25 per arm). At each timepoint, data will be collected on participants' access to psychosocial (PSO) services, psychological wellbeing, and satisfaction with care through participant medical record and a survey. To gain additional insights regarding the acceptability, feasibility, and impact of C\&C, a subset of 15 participants from the intervention group will be contacted for qualitative exit interviews. Expected outcomes: There is limited evidence about the effects of lay navigation programs on access to PSO services among patients with lung cancer. This work addresses this knowledge gap by evaluating the feasibility, acceptability, and preliminary impact of C\&C on patients with lung cancer. The findings of the proposed work will expand the body of evidence supporting lay navigation to the lung cancer population, contributing to the evidence base for patient-centred care.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Lung cancer
- NCT number
- NCT07548788
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 1 Apr 2026 to the primary completion date, 1 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Behavioural safety alert on medical record that would make their participation in Care \& Connect inappropriate
- Enrolment in another navigation study within University Health Network
- Patients who come to PM for a clinical trial visit
- Inability to communicate and read in English
Who the study is looking for
- Patient with diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) of any stage
- Age ≥ 18
- Have completed their first medical appointment at the Medical Oncology Lung Cancer Clinic at Princess Margaret Cancer Centre (PM), University Health Network
- Cognitive capacity to consent and complete questionnaires
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Center, University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.