Testing an Optimal Model of Patient-Centered Cancer Care

Cancer Clinical Trial

Official title:

Testing an Optimal Model of Patient-Centered Cancer Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921713
• Other study ID #: 1P20CA137219NN
• Secondary ID: 1P20CA137219
• Status: Completed
• Phase: N/A
• First received: June 4, 2009
• Last updated: October 11, 2017
• Start date: September 2008
• Est. completion date: August 2013

Study information

• Verified date: October 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Oncology Nurse Care Management

• Patient-centered materials

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care		5/2009 - 8/2011
Secondary	Treatment adherence and treatment outcomes of patients in Oncology Nurse Care Management versus Enhanced Usual Care		5/2009 - 8/2011