A Lay Navigation Intervention for Patients With Lung Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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 Questionnaire Completion — From study start date to the end of treatment at 6 months
  ≥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 — 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.

Trial sites (1)

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