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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Usability and effectiveness of the prototype

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

DerShung Yang, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BrightOutcome

Authority:

United States: Institutional Review Board

Study ID:

HC4ext

NCT ID:

NCT01108315

Start Date:

January 2010

Completion Date:

October 2011

Related Keywords:

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

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Seattle Cancer Care AllianceSeattle, Washington  98109