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.
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
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
Parallel
Care & Connect
Behavioral6-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.
Feasibility Assessed by Recruitment Rates
≥50% recruitment rate (#patients consented/ #patients eligible and approached)
Feasibility Assessed by Questionnaire Completion
≥80% baseline questionnaire completion rate (#patients who complete baseline questionnaire/ #patients consented)
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)
Feasibility Assessed by Protocol Adherence
≥65% of patients completing at least 1 session with a lay navigator
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.
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.
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.
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.
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.
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.
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).
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.
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