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OpenTrials
Completed

NCT Number: NCT00921713

Testing an Optimal Model of Patient-Centered Cancer Care

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oncology Nurse Care Management

Other

Patient-centered materials

Other

Primary outcomes

  1. 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

  1. Treatment adherence and treatment outcomes of patients in Oncology Nurse Care Management versus Enhanced Usual Care

    Time frame: 5/2009 - 8/2011

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Jun 16, 2009
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.