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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Niina Haas, BrightOutcome

Study Description
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Brief Summary:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85721
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
BrightOutcome
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
More Information
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Responsible Party: Niina Haas, Project Director, BrightOutcome
ClinicalTrials.gov Identifier: NCT01108315     History of Changes
Other Study ID Numbers: HC4ext
NCI ( Other Grant/Funding Number: HHSN261200700046C )
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012

Keywords provided by Niina Haas, BrightOutcome:
Patient Reported Outcomes (PRO)
Web-based
Phone-based
Breast Cancer