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Clinical Trials/NCT00921713
NCT00921713
Completed
Not Applicable

Testing an Optimal Model of Patient-Centered Cancer Care

Kaiser Permanente0 sites300 target enrollmentSeptember 2008
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Kaiser Permanente
Enrollment
300
Primary Endpoint
Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
August 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • They plan to disenroll from GH or be out of the area in the coming year; or
  • Primary care physician or specialty physician expects survival to be less than 12 months; or
  • Don't speak English; or
  • 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.

Outcomes

Primary Outcomes

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 Outcomes

  • Treatment adherence and treatment outcomes of patients in Oncology Nurse Care Management versus Enhanced Usual Care(5/2009 - 8/2011)

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