A Lay Navigation Intervention for Patients With Lung Cancer

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

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

≥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)

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

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 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.

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 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 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.

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.

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).

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.

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 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 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 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.

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.