A Lay Navigation Intervention for Patients With Lung Cancer

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Feasibility Assessed by Recruitment Rates [Time frame: From study start date to the end of treatment at 6 months]
• Feasibility Assessed by Questionnaire Completion [Time frame: From study start date to the end of treatment at 6 months]
• Feasibility Assessed by Questionnaire Completion [Time frame: From study start date to the end of treatment at 6 months]
• Feasibility Assessed by Protocol Adherence [Time frame: From study start date to the end of treatment at 6 months]
• Acceptability [Time frame: This measure will be administered at 3 months and 6 months]

Secondary outcome measures (7)

• Referral of Care to Psychosocial Oncology Services [Time frame: From study start date to the end of treatment at 6 months]
• Referral of Care to Palliative Services [Time frame: From study start date to the end of treatment at 6 months]
• Depressive symptoms using the PHQ-9 [Time frame: This measure will be administered at baseline, 3 months and 6 months]
• Generalized anxiety symptoms using the GAD-7 [Time frame: This measure will be administered at baseline, 3 months and 6 months]
• Distress about death and dying symptoms using the DADDS [Time frame: This measure will be administered at baseline, 3 months and 6 months]
• Patient satisfaction with cancer care using the PSCC [Time frame: This measure will be administered at baseline, 3 months and 6 months]
• Patient satisfaction with cancer care using the CEQ-INS [Time frame: This measure will be administered at baseline, 3 months and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Canada · 1 center

• Princess Margaret Cancer Center, University Health Network — Toronto

Identifiers

NCT: NCT07548788 · CAPCR#24-5089

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗