Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

NCT01108315 | Completed Phase 1

• 2 other identifiers: HC4extNCI
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

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

Keywords

Patient Reported Outcomes (PRO); Web-based; Phone-based; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Usability and effectiveness of the prototype

  Usability and effectiveness of BrightOutcome's web and phone-based symptom reporting and assessment software as it pertains to patient/provider communication

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• BrightOutcome: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Arizona Cancer Center

Tucson, Arizona, 85721, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• DerShung Yang, PhD

  BrightOutcome

  PRINCIPAL INVESTIGATOR

• VK Gadi, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Ana Maria Lopez, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 22, 2010
• Study Start: January 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 6, 2012

Record last verified: 2012-02

Locations

US (2)