Patient-reported Outcome Questionnaire for Women With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01282931
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : October 12, 2011
Information provided by (Responsible Party):
Susan Mathias, Health Outcomes Solutions

Brief 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.

Condition or disease
Metastatic Breast Cancer

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:

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
Estimated Enrollment : 200 participants
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.
Study Start Date : January 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01282931

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

Additional Information:
Responsible Party: Susan Mathias, Principal Investigator, Health Outcomes Solutions Identifier: NCT01282931     History of Changes
Other Study ID Numbers: HOS-10-002
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Susan Mathias, Health Outcomes Solutions:
Stage IV
Breast Cancer

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