Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Arizona Cancer Center, Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Report symptoms via web or phone-based system

Other

The participant reports their symptoms at least twice a week via the phone or web-based prototype system.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

BrightOutcome

Industry

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 22, 2010
Registry last updated: Feb 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed