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Patient-reported Outcome Questionnaire for Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Susan Mathias, Health Outcomes Solutions
ClinicalTrials.gov Identifier:
NCT01282931
First received: January 24, 2011
Last updated: October 9, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition
Metastatic Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Health Outcomes Solutions:

Estimated Enrollment: 200
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Female 18 and older U.S. resident Clinical diagnosis of metastatic breast cancer

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282931

Locations
United States, Florida
Health Outcomes Solutions
Winter Park, Florida, United States, 32790
Sponsors and Collaborators
Health Outcomes Solutions
Investigators
Principal Investigator: Susan D. Mathias Health Outcomes Solutions
  More Information

Additional Information:
Online location of study questionnaire  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Susan Mathias, Principal Investigator, Health Outcomes Solutions
ClinicalTrials.gov Identifier: NCT01282931     History of Changes
Other Study ID Numbers: HOS-10-002
Study First Received: January 24, 2011
Last Updated: October 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Health Outcomes Solutions:
Women
Stage IV
Metastatic
 Breast Cancer
Progressed
Progression

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013