Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Report symptoms via web or phone-based system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* The participant reports their symptoms at least twice a week via the phone or web-based prototype system.<br>|
| No Intervention: Usual Care<br>The participants on this arm do not record their symptoms. They report symptoms as they would under usual care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Reported Outcomes (PRO), Web-based, Phone-based, Breast Cancer