Testing an Optimal Model of Patient-Centered Cancer Care

NCT00921713 | Completed

• 2 other identifiers: 1P20CA137219NN1P20CA137219
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer

Keywords

Early cancer care

Outcome Measures

Primary Outcomes (1)

• Quality of life and satisfaction with care between patients in Oncology Nurse Care Management versus Enhanced Usual Care

  5/2009 - 8/2011

Secondary Outcomes (1)

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

  5/2009 - 8/2011

Study Arms (2)

Enhanced Usual Care

ACTIVE COMPARATOR

An extensive packet of information including cancer education materials and treatment resources will be mailed to patients.

Other: Patient-centered materials

Oncology Nurse Care Management

EXPERIMENTAL

In addition to this mailed information packet, patients in OCNM will be contacted by an experienced Oncology nurse with additional training in self-management support and psychosocial care. The intervention nurse, supported by a Medical Oncologist and Clinical Psychologist, will work closely with patients, their primary care physicians, and other clinicians to assure that patient needs discussed are met. The nurses will be trained in and employ proven counseling and psychotherapeutic approaches-behavioral activation and problem-solving treatment. The multi-component intervention will be based on the Chronic Care Model's six elements (health care organization, community resources, self-management support, delivery system design, decision support, and clinical information system).

Other: Oncology Nurse Care Management

Interventions

Oncology Nurse Care Management OTHER

Oncology Nurse Care Management

Patient-centered materials OTHER

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Edward Wagner, MD, MPH

  Group Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 16, 2009
• Study Start: September 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2013
• Last Updated: October 13, 2017

Record last verified: 2017-10