Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

• ClinicalTrials.gov Identifier: NCT01108315
• Recruitment Status: Completed
• First Posted: April 22, 2010
• Last Update Posted: February 6, 2012
• Sponsor: BrightOutcome
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Niina Haas, BrightOutcome

Study Description

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

• 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

Arms and Interventions

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

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

• 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

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

• Responsible Party: Niina Haas, Project Director, BrightOutcome
• ClinicalTrials.gov Identifier: NCT01108315
• Other Study ID Numbers: HC4ext; NCI ( Other Grant/Funding Number: HHSN261200700046C )
• First Posted: April 22, 2010
• 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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases