Effectiveness of Lay Navigators in Meeting Cancer Patients' Non-Clinical Needs: A Pilot Study
Pilot Project to Better Understand Non-Clinical Needs of Cancer Patients
1 other identifier
interventional
1,053
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2017
CompletedFirst Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
August 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedApril 8, 2019
April 1, 2019
1.5 years
May 4, 2017
April 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Utilization of non-treatment-related cancer services
0-18 months after eligibility is determined
Study Arms (2)
Lay Navigation
EXPERIMENTALPatients with even MRN.
Usual Care
NO INTERVENTIONPatients with odd MRN.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Cancer Center
Palo Alto, California, 94305, United States
Related Publications (4)
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.
PMID: 27670770BACKGROUNDO'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.
PMID: 20851841BACKGROUNDProctor 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.
PMID: 20957426BACKGROUNDWinget 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.
PMID: 31647691DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve Asch, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking occurs.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
May 4, 2017
First Posted
August 10, 2017
Study Start
February 15, 2017
Primary Completion
July 31, 2018
Study Completion
December 31, 2018
Last Updated
April 8, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share