Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108315
• Other study ID #: HC4ext
• Secondary ID: NCI
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 20, 2010
• Last updated: February 2, 2012
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2012
• Source: BrightOutcome
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Arizona Cancer Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
BrightOutcome	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No