Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study

Study Overview
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Brief Summary
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The Stanford Cancer Center is undertaking a Transformation Initiative in order to improve the quality of care and care coordination across the continuum of care. The newest innovation is to introduce lay navigators to specified high-need patients. The larger goal of the project is to assess whether lay navigators can address non-clinical patient needs in a timely fashion and appropriately connect them with their clinical team when warranted. It is expected that proactive interaction with patients will decrease patient anxiety/stress related to their cancer and facilitate higher patient engagement and improved management of physical, social,and emotional health. For the pilot project, the smaller goal is to understand: how lay navigator time is used; the types and frequency of issues brought up by patients; resources that patients are given or referred to; type and frequency of mode of contact with patients; and patients' acceptance of navigators based on refusal. An electronic intake form will be used to collect this information so that data can be analyzed regularly to inform changes to the navigator program as needed.

Detailed Description
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The Stanford Cancer Institute is undergoing a 5-year Transformation Initiative that began in 2013. One of the goals of this initiative is to increase patient engagement. The underlying premise is that engaged patients will be more likely to attend all their visits, receive all their treatments, and understand ways to manage treatment side effects so that they are less likely to go to the emergency room (ER) or be admitted to the hospital. An approach being tested is to use lay navigators to help identify patient issues and help them address the issues through a combination of direct supportive activities (e.g., calling clinical team for the patient) and activities that help the patients help themselves (helping them understand when side effects warrant a call to their clinical team that they make themselves). Information including patient acceptance/refusal of navigator services; number and types of contacts with patients (phone, in-person, email); types of issues discussed (financial, social, educational, physical, emotional, etc); referrals made; and time spent with patients for each encounter will be routinely entered by the navigators for each patient contact. The data entered will be evaluated regularly to closely monitor navigator activities and better understand cancer patient issues/needs. This information will be used to inform possible training needs of navigators, educational needs of patients,needs for better referral support,help predict navigator case-load, and other issues. Eligibility Criteria: All new biopsy positive cancer patients that have a treatment plan to receive at least 2 treatment modalities: surgery, chemotherapy and/or radiation therapy at Stanford are eligible. Because there will be more patients eligible than the navigators can manage, only patients with an even MRN will receive a navigator for the pilot. The overall purpose of the pilot is to learn which patients benefit most and which services navigators are able to best help with. The investigators expect the pilot to last 6-12 months. Mixed methods will be used to evaluate the navigators and will include existing patient experience surveys, unscheduled hospitalizations, ER visits, interviews with patients, staff (including navigators), and physicians regarding their experience with and perceived value of navigators.

Official Title
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Pilot Project to Better Understand Non-Clinical Needs of Cancer Patients

Conditions
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Neck Cancer, Breast Cancer, Gynecologic Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Thoracic Cancer, Cutaneous Tumor, Urologic Cancer, Neurologic Cancer, Lymphoma, Sarcoma, Bone Marrow Transplant

Intervention / Treatment
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* Other: Lay Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New patient to eligible Cancer Care Program (CCP) Biopsy positive Plan to receive at least one treatment modality at Stanford: surgery, chemotherapy and/or radiation therapy Cancer that is treated by any of the following CCPs: Breast, Gynecologic oncology, Head/neck, Cutaneous (melanoma only), Thoracic, Gastrointestinal Patient has even numbered MRN Exclusion Criteria: Anyone with odd numbered MRN Anyone in other cancer programs that are not included Biopsy negative No treatment modality received Patients with already established care/treatment i.e. not new patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be 12 groups in each arm which reflects the 12 different cancer types.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lay Navigation<br>Patients with even MRN. | Other: Lay Navigation<br>* Patients who are assigned to intervention will be contacted by a navigator who will explain and offer their services to the patient. Navigators focus efforts on supporting patients in self-management and in supporting non-medical needs.<br>|
| No Intervention: Usual Care<br>Patients with odd MRN. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Experience/Satisfaction: Difference in topbox scores | Difference in topbox scores from apriori selected questions from the transformation evaluation in navigated vs not navigated patients. | 3-18 months after eligibility is determined | 
| Rates of unplanned hospitalization and ER visits | Comparison of rates of unplanned hospitalizations and ER visits among eligible patients in the navigated group vs. un-navigated patients. | 0-18 months after eligibility is determined | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of non-treatment-related cancer services | Comparison of the proportion of navigated patients that used non-treatment-related cancer services to those not navigated. Examples of services include palliative care, supportive care, nutrition, etc. | 0-18 months after eligibility is determined | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lay Navigator, Quality of Care, High-Need Cancer Treatment Regimen