Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

Phase II Study of Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

Cancer symptoms due to disease progression or side effects caused by cancer treatment are prevalent. Most cancer patients are treated in outpatient settings. Patients may be provided with patient education materials and counseled on anticipated side effects while being provided with different self-management options and warnings regarding when medical care is required. Despite these efforts, many people feel set adrift in having to self-manage treatment and illness related symptoms at home resulting in a sense of burden for the patient and the caregiver.

When the patient does visit the doctor, they increasingly are asked questions to elicit information about symptoms and performance using structured questionnaires that are shown to give reproducible, meaningful, quantitative assessments of how patients feel and how they function-measures that are called patient reported outcomes or PROs. The questionnaires used to collect this information are called PRO instruments. The use of PRO instruments is part of a general movement toward the idea that the patient, properly queried, is the best source of information about how he or she feels. The goal of using PRO measures is to provide better information to doctors and patients so that the best treatment for patients can be determined.

PURPOSE: To reduce the isolation of patients/caregivers from the medical care team and to improve patient/provider communication and clinical decisions by keeping documented daily reports of patient symptoms online, having notifications sent to the medical team of moderate to severe symptoms and by reviewing these reports at clinic visits with the medical staff.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Report symptoms via web or phone-based system

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85721
      • Arizona Cancer Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female, breast oncology patient
• Breast cancer diagnosis
• Expected chemotherapy regimen of at least 3-4 months
• Sufficient cognitive ability and psychological stability in the opinion of treating physician
• Fluent in spoken and written English
• 18 years of age or older
• Outpatient
• Life expectancy > 6 months as estimated by treating physician
• Informed of the investigational nature of this study and provided informed consent.
• Has access to either a phone or the internet

Exclusion Criteria:

• Is not female, nor a breast oncology patient
• Does not have breast cancer diagnosis
• Expected chemotherapy regimen is less than 3-4 months
• Does not have sufficient cognitive ability and psychological stability in the opinion of treating physician
• Is not fluent in spoken and written English
• Is younger than 18 years of age
• Inpatient
• Life expectancy < 6 months as estimated by treating physician
• Is not informed of the investigational nature of this study and does not provide informed consent.
• Does not have access to either a phone or internet.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The participant used the web and/or phone-based PRO reporting symptoms to enter symptoms twice a week at minimum.	Other: Report symptoms via web or phone-based system; The participant reports their symptoms at least twice a week via the phone or web-based prototype system.
No Intervention: Usual Care; The participants on this arm do not record their symptoms. They report symptoms as they would under usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability and effectiveness of the prototype	Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication	6 months

Collaborators and Investigators

• Sponsor: BrightOutcome
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: DerShung Yang, PhD, BrightOutcome; Principal Investigator: VK Gadi, MD, University of Washington; Principal Investigator: Ana Maria Lopez, MD, University of Arizona

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Estimate): February 6, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Breast Cancer; Web-based; Patient Reported Outcomes (PRO); Phone-based
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HC4ext; NCI (HHSN261200700046C)