18 Years
N/A
Both
Cancer
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care
Outcome Measure:
Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care
Outcome Time Frame:
5/2009 - 8/2011
Safety Issue:
No
Principal Investigator
Edward Wagner, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Group Health Research Institute
Authority:
United States: Institutional Review Board
Study ID:
1P20CA137219NN
NCT ID:
NCT00921713
Start Date:
May 2009
Completion Date:
August 2013
Related Keywords:
- Cancer
- Early cancer care
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