A Lay Navigation Intervention for Patients With Lung Cancer

NCT07548788 | Not Yet Recruiting

• 1 other identifier: CAPCR#24-5089
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer Non-Small Cell Cancer (NSCLC); Lung Cancer Small Cell Lung Cancer (SCLC); Patient Navigation

Keywords

Lay navigation; Lung cancer; Access to care; Patient navigation; Feasibility; RCT; Pilot; Acceptability

Outcome Measures

Primary Outcomes (5)

• Feasibility Assessed by Recruitment Rates

  ≥50% recruitment rate (#patients consented/ #patients eligible and approached)

  From study start date to the end of treatment at 6 months

• Feasibility Assessed by Questionnaire Completion

  ≥80% baseline questionnaire completion rate (#patients who complete baseline questionnaire/ #patients consented)

  From study start date to the end of treatment at 6 months

• Feasibility Assessed by Questionnaire Completion

  ≥65% questionnaire completion rate at follow-up (i.e., 3- and 6-months) (#patients who complete each follow-up questionnaire/ #patients matched with a navigator or #patients who complete each follow-up questionnaire/ #patients randomized to the control group)

  From study start date to the end of treatment at 6 months

• Feasibility Assessed by Protocol Adherence

  ≥65% of patients completing at least 1 session with a lay navigator

  From study start date to the end of treatment at 6 months

• Acceptability

  Intervention acceptability will be assessed using the Patient Satisfaction with Navigator-Interpersonal Relationship scale (PSN-I), a 9-item self-report measure of patients' satisfaction with the relationship with their navigator. Higher PSN-I scores indicate greater patient satisfaction. Acceptability is defined as ≥70% of participants scoring ≥30 on the PSN-I.

  This measure will be administered at 3 months and 6 months

Secondary Outcomes (7)

• Referral of Care to Psychosocial Oncology Services

  From study start date to the end of treatment at 6 months

• Referral of Care to Palliative Services

  From study start date to the end of treatment at 6 months

• Depressive symptoms using the PHQ-9

  This measure will be administered at baseline, 3 months and 6 months

• Generalized anxiety symptoms using the GAD-7

  This measure will be administered at baseline, 3 months and 6 months

• Distress about death and dying symptoms using the DADDS

  This measure will be administered at baseline, 3 months and 6 months

Other Outcomes (5)

• Health related quality of life using the FACT-G

  This measure will be administered at baseline, 3 months and 6 months

• Perceived social support using the ESSI

  This measure will be administered at baseline, 3 months and 6 months

• Patient activation using the PAM-13

  This measure will be administered at baseline, 3 months and 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group receive Care \& Connect (C\&C), a 6-month lay navigation program, in addition to usual care. Trained lay navigators provide psychosocial and informational support and assist with health system navigation, including directing patients to appropriate resources, facilitating referrals to psychosocial services as appropriate, and connecting participants with relevant hospital and community resources.

Behavioral: Care & Connect

Usual Care

NO INTERVENTION

Participants in the control group receive usual care, including routine treatment and follow up in outpatient oncology clinics. Usual care includes distress screening (whereby patients are invited to complete the Edmonton Symptom Assessment System-Revised as part of clinic visits), with results reviewed by clinic staff and communicated to oncologists for further assessment and referral to specialized services as needed. Participants may also be referred to specialized services based on clinical judgement or patient request and have access to standard informational and educational resources available through the hospital.

Interventions

Care & Connect BEHAVIORAL

6-month lay navigation program. Lay navigators provide basic psychosocial and informational support and health system navigation through phone call or video conference. Sessions held with patients are variable based on patients' needs.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Center, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gilla K Shapiro, PhD

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

• Gary Rodin, MD

  Princess Margaret Cancer Centre, University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilla K Shapiro, PhD

CONTACT

416-946-4501 ext.4211; gilla.shapiro@uhn.ca

Research Coordinator

CONTACT

CACResearch@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)