Metastatic Breast CancerNCT01282931
Patient-reported Outcome Questionnaire for Women With Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by Health Outcomes Solutions at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female 18 and older U.S. resident Clinical diagnosis of metastatic breast cancer
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Outcomes Solutions
Winter Park, Florida, 32790
About this study
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.
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Keywords
- Women, Stage IV, Metastatic, Breast Cancer, Progressed, Progression
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis, Disease Progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Outcomes Solutions
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Mathias, Health Outcomes Solutions
- Investigators
- Susan D. Mathias, Principal investigator, Health Outcomes Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282931
- Sponsor's protocol ID
- HOS-10-002
- Status last verified
- Oct 2011
- First submitted
- 24 Jan 2011
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01282931
- Acronym / sponsor ID
- HOS-10-002
- Conditions
- Metastatic Breast Cancer
- Keywords
- Women, Stage IV, Metastatic, Breast Cancer, Progressed, Progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Health Outcomes SolutionsUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female 18 and older U.S. resident Clinical diagnosis of metastatic breast cancer
Key inclusion criteria (7 listed)
- Female
- Age 18 and older
- Clinical diagnosis of metastatic breast cancer
- U.S. resident
- Able to speak and read English
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
- Online location of study questionnaireLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan D. Mathias principal investigator
Health Outcomes Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Health Outcomes Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.