Patient-reported Outcome Questionnaire for Women With Metastatic Breast Cancer

October 9, 2011 updated by: Susan Mathias, Health Outcomes Solutions

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Winter Park, Florida, United States, 32790
        • Health Outcomes Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Outcomes Solutions

Investigators

  • Principal Investigator: Susan D. Mathias, Health Outcomes Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 24, 2011

First Posted (Estimate)

January 25, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 9, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOS-10-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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