Testing an Optimal Model of Patient-Centered Cancer Care

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00921713
First received: June 4, 2009
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

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 Intervention
Cancer
Other: Oncology Nurse Care Management
Other: Patient-centered materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921713

Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Edward Wagner, MD, MPH Group Health Research Institute
  More Information

No publications provided

Responsible Party: Ed Wagner, MD, MPH (Principal Investigator), Group Health Research Institute
ClinicalTrials.gov Identifier: NCT00921713     History of Changes
Other Study ID Numbers: 1P20CA137219NN
Study First Received: June 4, 2009
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Early cancer care

ClinicalTrials.gov processed this record on April 17, 2014