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
  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:


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
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, see Learn About Clinical Studies.

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:
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 August 28, 2014