Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

NCT ID: NCT01108315

Last Updated: 2012-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-10-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

The participant used the web and/or phone-based PRO reporting symptoms to enter symptoms twice a week at minimum.

Group Type: EXPERIMENTAL

Report symptoms via web or phone-based system

Intervention Type: OTHER

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

Usual Care

The participants on this arm do not record their symptoms. They report symptoms as they would under usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

BrightOutcome

INDUSTRY

Sponsor Role: lead

Responsible Party

Niina Haas

Project Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

DerShung Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

BrightOutcome

VK Gadi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Ana Maria Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Arizona Cancer Center

Tucson, Arizona, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HC4ext

Identifier Type: -

Identifier Source: org_study_id