Testing an Optimal Model of Patient-Centered Cancer Care
The purpose of this proposal is to develop and test the efficacy in a randomized, controlled clinical trial of an Oncology Nurse Care Management (ONCM) program to support cancer patients early in their course. The ONCM program will be compared with an Enhanced Usual Care (EUC) program that will provide education materials and treatment resources for patients. Efficacy will be measured by differences over time in participant-reported Quality of Life, Symptoms and Emotional Distress, and Quality of Care between patients receiving ONCM versus EUC.
Other: Oncology Nurse Care Management
Other: Patient-centered materials
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
- Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care [ Time Frame: 5/2009 - 8/2011 ] [ Designated as safety issue: No ]
- Treatment adherence and treatment outcomes of patients in Oncology Nurse Care Management versus Enhanced Usual Care [ Time Frame: 5/2009 - 8/2011 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Enhanced Usual Care
An extensive packet of information including cancer education materials and treatment resources will be mailed to patients.
|Other: Patient-centered materials|
Experimental: Oncology Nurse Care Management
In addition to this mailed information packet, patients in OCNM will be contacted by an experienced Oncology nurse with additional training in self-management support and psychosocial care. The intervention nurse, supported by a Medical Oncologist and Clinical Psychologist, will work closely with patients, their primary care physicians, and other clinicians to assure that patient needs discussed are met. The nurses will be trained in and employ proven counseling and psychotherapeutic approaches-behavioral activation and problem-solving treatment. The multi-component intervention will be based on the Chronic Care Model's six elements (health care organization, community resources, self-management support, delivery system design, decision support, and clinical information system).
|Other: Oncology Nurse Care Management|
Our primary goal is to assess the impact on quality of life, quality of care, and other outcomes of two programs designed to support patients newly diagnosed with breast, colorectal, and lung cancer patients. The Oncology Nurse Care Management (ONCM) and Enhanced Usual Care (EUC) interventions will be implemented and evaluated among enrollees of Group Health.
A.1. To develop a robust early cancer notification system based on automated data to facilitate intervention shortly after cancer diagnosis.
A.2. To implement an Oncology Nurse Care Management program that addresses patient questions, symptoms, psychosocial needs, and facilitates timely, coordinated care.
A.3. To compare the impact of the Oncology Nurse Care Manager Program with Enhanced Usual Care in Group Health cancer patients using a randomized clinical trial design. Our two primary outcomes are quality of life and patients' perspectives of quality of care. As secondary outcomes, we will evaluate the impact of the intervention on psychosocial distress and depression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921713
|Principal Investigator:||Edward Wagner, MD, MPH||Group Health Research Institute|