Clinical trial NCT01108315: Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice
Official title: Phase II Study of Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Keywords: Patient Reported Outcomes (PRO)
Web-based
Phone-based
Breast Cancer
Lead sponsor: BrightOutcome
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-04-22
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Usability and effectiveness of the prototype
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: BrightOutcome
name: DerShung Yang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: VK Gadi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Ana Maria Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References: