Lung Cancer Non-Small Cell Cancer (NSCLC), Lung Cancer Small Cell Lung Cancer (SCLC), Patient Navigation
Conditions
Keywords
Lay navigation, Lung cancer, Access to care, Patient navigation, Feasibility, RCT, Pilot, Acceptability
Brief summary
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
BEHAVIORALCare & 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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Assessed by Recruitment Rates | From study start date to the end of treatment at 6 months | ≥50% recruitment rate (#patients consented/ #patients eligible and approached) |
| Feasibility Assessed by Questionnaire Completion | From study start date to the end of treatment at 6 months | ≥80% baseline questionnaire completion rate (#patients who complete baseline questionnaire/ #patients consented) |
| Feasibility Assessed by Protocol Adherence | From study start date to the end of treatment at 6 months | ≥65% of patients completing at least 1 session with a lay navigator |
| Acceptability | This measure will be administered at 3 months and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Referral of Care to Psychosocial Oncology Services | From study start date to the end of treatment at 6 months | 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 | From study start date to the end of treatment at 6 months | 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 | This measure will be administered at baseline, 3 months and 6 months | 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 | This measure will be administered at baseline, 3 months and 6 months | 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 symptoms using the DADDS | This measure will be administered at baseline, 3 months and 6 months | 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 using the PSCC | This measure will be administered at baseline, 3 months and 6 months | 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 using the CEQ-INS | This measure will be administered at baseline, 3 months and 6 months | 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. |
Countries
Canada
Contacts
CONTACTGilla K Shapiro, PhD
CONTACTResearch Coordinator
PRINCIPAL_INVESTIGATORGilla K Shapiro, PhD
Princess Margaret Cancer Centre, University Health Network
PRINCIPAL_INVESTIGATORGary Rodin, MD
Princess Margaret Cancer Centre, University Health Network
Outcome results
None listed