Testing an Optimal Model of Patient-Centered Cancer Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00921713
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : October 13, 2017
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Other: Oncology Nurse Care Management Other: Patient-centered materials Not Applicable

Detailed Description:

Overall Goal:

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.

Specific Aims:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Testing an Optimal Model of Patient-Centered Cancer Care
Study Start Date : September 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : August 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care [ Time Frame: 5/2009 - 8/2011 ]

Secondary Outcome Measures :
  1. Treatment adherence and treatment outcomes of patients in Oncology Nurse Care Management versus Enhanced Usual Care [ Time Frame: 5/2009 - 8/2011 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. On the panel of an eligible and consenting primary care physician;
  2. Diagnosed with a new occurrence of breast (females only) , colorectal, or lung cancer within the past three weeks;
  3. Age 18 or older; and
  4. Able to complete the baseline questionnaire.

Exclusion Criteria:

  1. They plan to disenroll from GH or be out of the area in the coming year; or
  2. Primary care physician or specialty physician expects survival to be less than 12 months; or
  3. Don't speak English; or
  4. Have moderate cognitive impairment (a score of 3 or more on a six-item validated instrument, or psychosis as assessed by ICD-9 codes from GH medical record data.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00921713

Sponsors and Collaborators
Kaiser Permanente
Principal Investigator: Edward Wagner, MD, MPH Group Health Research Institute

Responsible Party: Kaiser Permanente Identifier: NCT00921713     History of Changes
Other Study ID Numbers: 1P20CA137219NN
1P20CA137219 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
Early cancer care