Breast Cancer Clinical Trial

Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT01108315

Recruitment Status:

Completed

Sponsor:

BrightOutcome

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There are 2 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

138

Study ID:

NCT01108315

Recruitment Status:

Completed

Sponsor:


BrightOutcome

How clear is this clinincal trial information?

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