Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice
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|ClinicalTrials.gov Identifier: NCT01108315|
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : February 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Report symptoms via web or phone-based system||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||138 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Study of Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
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.
- Usability and effectiveness of the prototype [ Time Frame: 6 months ]Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108315
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85721|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||DerShung Yang, PhD||BrightOutcome|
|Principal Investigator:||VK Gadi, MD||University of Washington|
|Principal Investigator:||Ana Maria Lopez, MD||University of Arizona|