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

Primary Purpose

Breast Cancer, Gynecologic Cancer, Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lay Navigation
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Lay Navigator, Quality of Care, High-Need Cancer Treatment Regimen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lay Navigation

Usual Care

Arm Description

Patients with even MRN.

Patients with odd MRN.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 4, 2017
Last Updated
April 5, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03245788
Brief Title
Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study
Official Title
Pilot Project to Better Understand Non-Clinical Needs of Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gynecologic Cancer, Neck Cancer, Head and Neck Cancer, Gastrointestinal Cancer, Thoracic Cancer, Cutaneous Tumor, Urologic Cancer, Neurologic Cancer, Lymphoma, Sarcoma, Bone Marrow Transplant
Keywords
Lay Navigator, Quality of Care, High-Need Cancer Treatment Regimen

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There will be 12 groups in each arm which reflects the 12 different cancer types.
Masking
None (Open Label)
Masking Description
No masking occurs.
Allocation
Randomized
Enrollment
1053 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lay Navigation
Arm Type
Experimental
Arm Description
Patients with even MRN.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients with odd MRN.
Intervention Type
Other
Intervention Name(s)
Lay Navigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Experience/Satisfaction: Difference in topbox scores
Description
Difference in topbox scores from apriori selected questions from the transformation evaluation in navigated vs not navigated patients.
Time Frame
3-18 months after eligibility is determined
Title
Rates of unplanned hospitalization and ER visits
Description
Comparison of rates of unplanned hospitalizations and ER visits among eligible patients in the navigated group vs. un-navigated patients.
Time Frame
0-18 months after eligibility is determined
Secondary Outcome Measure Information:
Title
Utilization of non-treatment-related cancer services
Description
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.
Time Frame
0-18 months after eligibility is determined

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Asch, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Cancer Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27670770
Citation
Hennink MM, Kaiser BN, Marconi VC. Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough? Qual Health Res. 2017 Mar;27(4):591-608. doi: 10.1177/1049732316665344. Epub 2016 Sep 26.
Results Reference
background
PubMed Identifier
20851841
Citation
O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ. 2010 Sep 17;341:c4587. doi: 10.1136/bmj.c4587. No abstract available.
Results Reference
background
PubMed Identifier
20957426
Citation
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
Results Reference
background
PubMed Identifier
31647691
Citation
Winget M, Holdsworth L, Wang S, Veruttipong D, Zionts D, Rosenthal EL, Asch SM. Effectiveness of a Lay Navigation Program in an Academic Cancer Center. JCO Oncol Pract. 2020 Jan;16(1):e75-e83. doi: 10.1200/JOP.19.00337. Epub 2019 Oct 24.
Results Reference
derived

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

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