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NCT01282931 Clinical Trial

Patient-reported Outcome Questionnaire for Women With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:
Development and Implementation of a Patient-reported Outcome Questionnaire to Assess the Value of Progression-free Survival for Women With Metastatic Breast Cancer.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01282931
Other study ID # HOS-10-002
Secondary ID
Status Completed
Phase N/A
First received January 24, 2011
Last updated October 9, 2011
Start date January 2011
Est. completion date March 2011

Study information
Verified date October 2011
Source Health Outcomes Solutions
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The goal of the study is to understand the meaning of progression-free survival for women with metastatic breast cancer and to use this understanding to create and distribute a new questionnaire to assess the effect progression has on a woman's functioning and well-being.

Description:

This study is being conducted in three stages. Stages I and II are complete. Participation in Stage III requires the completion of an online survey. The survey may be accessed at the following link:

https://www.surveymonkey.com/s/mbc3survey

Compensation options for eligible participants are listed at the end of the survey.

Eligibility will be confirmed in follow-up call/email by study staff.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female

- Age 18 and older

- Clinical diagnosis of metastatic breast cancer

- U.S. resident

- Able to speak and read English

- Willing to sign and informed consent

- Willing to self-administer one online questionnaire that will take approximately 15 minutes to complete

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Health Outcomes Solutions Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Health Outcomes Solutions

Country where clinical trial is conducted

United States, 

See also
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