Clinical trial NCT00921713: Testing an Optimal Model of Patient-Centered Cancer Care
Official title: Testing an Optimal Model of Patient-Centered Cancer Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Early cancer care
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care
timeFrame: 5/2009 - 8/2011
Secondary outcomes:
measure: Treatment adherence and treatment outcomes of patients in Oncology Nurse Care Management versus Enhanced Usual Care
timeFrame: 5/2009 - 8/2011
Other outcomes:
Locations:
Study officials:
affiliation: Group Health Research Institute
name: Edward Wagner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: