A Lay Navigation Intervention for Patients With Lung Cancer

Feasibility and Acceptability of the Care and Connect Program for Patients With Lung Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer Non-Small Cell Cancer (NSCLC); Lung Cancer Small Cell Lung Cancer (SCLC); Patient Navigation
• Intervention / Treatment: Behavioral: Care & Connect

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilla K Shapiro, PhD; Phone Number: 416-946-4501 ext.4211; Email: gilla.shapiro@uhn.ca
• Study Contact Backup: Name: Research Coordinator; Email: CACResearch@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Princess Margaret Cancer Center, University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; 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.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral of Care to Psychosocial Oncology Services	This outcome is operationalized as the proportion of patients and patient's number of sessions of specialized Psychosocial Oncology (PSO) services within the hospital setting during the study period. Data regarding PSO services use will be collected from participants' medical record.	From study start date to the end of treatment at 6 months
Referral of Care to Palliative Services	This outcome is operationalized as the proportion of patients and patient's number of sessions of specialized palliative care within the hospital setting during the study period. Data regarding palliative care use will be collected from participants' medical record.	From study start date to the end of treatment at 6 months
Depressive symptoms using the PHQ-9	Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item measure of depression. A four-point Likert scale scores from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. Higher scores are related to higher depression severity.	This measure will be administered at baseline, 3 months and 6 months
Generalized anxiety symptoms using the GAD-7	Generalized anxiety will be assessed using the Generalized Anxiety Disorder scale (GAD-7). The GAD-7 is a 7-item self-report measure designed to screen the severity of GAD symptoms. Items are scored on a four-point Likert scale ranging from 0 (not at all) to 3 (nearly every day) with a total score ranging from 0 to 21. Scores from 0-4 indicate minimal anxiety, 5-9 indicate mild anxiety, 10-14 indicate moderate anxiety, and 15-21 indicate severe anxiety.	This measure will be administered at baseline, 3 months and 6 months
Distress about death and dying symptoms using the DADDS	Distress about death and dying will be assessed using the Death and Dying Distress Scale (DADDS). The DADDS is a 15-item self-report measure assessing specific concerns of advanced cancer patients about end of life, feeling a burden to others and wasted opportunities. It is scored on a six-point Likert scale from 0 (no distress) to 5 (very much distress), with a total score ranging from 0 to 75, a greater score indicating higher death anxiety and distress.	This measure will be administered at baseline, 3 months and 6 months
Patient satisfaction with cancer care using the PSCC	Patient satisfaction with cancer care will be measured with the Patient Satisfaction with Cancer-Related Care Measure (PSCC). The PSCC is an 18-item questionnaire that addresses multiple domains, including: access/logistics, interpersonal skills of the provider, information gathering and reporting, and coordination of care. PSCC items are rated on 5-point Likert scales: "1 = Strongly Agree", "2 = Agree", "3 = Neutral", "4 = Disagree", and "5 = Strongly Disagree". A lower PSCC total score indicates higher satisfaction level. The PSCC questionnaire has a score range between a minimum of 18 (best score) and a maximum of 90 (worst score).	This measure will be administered at baseline, 3 months and 6 months
Patient satisfaction with cancer care using the CEQ-INS	Patient satisfaction with cancer care will be measured with the Clinical Evaluation Questionnaire-Information Navigation and Support (CEQ-INS). CEQ-INS is a 19-item self-reported instrument with questions used 4-point Likert scale (1 'Not at All' to 4 'Very Much'). Higher scores correlate with higher patient satisfaction with the information and support provided from their care team.	This measure will be administered at baseline, 3 months and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life using the FACT-G	HRQoL will be assessed with the Functional Assessment of Cancer Therapy - General (FACT-G). The FACT-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and functional well-being. Each of the questions will be scored on a scale from 0 (Not at all) to 4 (Very much) using a manual scoring template in which some items are reverse scored. The minimally important difference (MID) is 5 points for the FACT-G questionnaire. In other words, five points is the most minimal difference between the control group and treatment group scores that would indicate a clinically meaningful change. A positive change in points indicates better QOL.	This measure will be administered at baseline, 3 months and 6 months
Perceived social support using the ESSI	Perceived social support will be measured using the ENRICHD Social Support Instrument (ESSI). ESSI is a 7-item scale used to measure perceived social support. The first six items have a rating scale of 1 (none of the time) to 5 (all of the time) and the seventh is scored 4 for 'yes' and 2 for 'no'. Total scores range from 8 to 34. A lower total score reflects less support.	This measure will be administered at baseline, 3 months and 6 months
Patient activation using the PAM-13	Patient activation will be measured using the Patient Activation Measure-13 items (PAM-13). The PAM-13 measures patient activation through self-reports of knowledge, skills, and confidence related to self-management of one's own health care. This 13-item self-report assesses confidence in self-management and understanding of health condition. Each of the 13 items scored on a 5-point Likert scale. The primary outcome is an activation score derived from the 13 items (possible range of 0-100, higher scores indicating higher patient activation in self-management).	This measure will be administered at baseline, 3 months and 6 months
Access to psychosocial services outside of the hospital	This includes the number, duration, and date of psychosocial appointments that are received outside of the hospital setting during the study period. This will be self-reported by participants.	From study start date to the end of treatment at 6 months
Healthcare utilization using the Health Care Utilization Questionnaire	Healthcare utilization will be measured using the Health Care Utilization Questionnaire. The Health Care Utilization Questionnaire is a 12 item self-report instrument designed to capture participants' use of healthcare services during the study period. Responses are recorded as counts of service use and will be used to estimate overall healthcare utilization during the study period, with higher values indicating greater use of healthcare services.	This measure will be administered at baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Gary Rodin, MD, Princess Margaret Cancer Centre, University Health Network; Principal Investigator: Gilla K Shapiro, PhD, Princess Margaret Cancer Centre, University Health Network

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Access to care; Feasibility; Lung cancer; RCT; Acceptability; Patient navigation; Pilot; Lay navigation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
• Other Study ID Numbers: CAPCR#24-5089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No