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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
50
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.
Princess Margaret Cancer Center, University Health Network
Toronto, Ontario, Canada
Feasibility Assessed by Recruitment Rates
≥50% recruitment rate (#patients consented/ #patients eligible and approached)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: This measure will be administered at 3 months and 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: This measure will be administered at baseline, 3 months and 6 months
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