Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer
NCT03375827
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- Age ≥ 18
- Diagnosed with stage IV breast cancer within the past 3 years
- Receiving care at the MGH Cancer Center
- Verbal and written fluency in English
- Within 6 weeks of a new line of breast cancer therapy and/or progression on scans and/or a change in current breast cancer therapy regimen
- Unwilling or unable to participate in the study
- Is medically or otherwise unable to participate (as determined by a physician or study
PI)
- Enrolled in hospice
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Descriptive Information | |||||
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Brief Title ICMJE | Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer | ||||
Official Title ICMJE | Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer | ||||
Brief Summary | This research study is evaluating whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit helps improve communication and decision-making in breast cancer care. | ||||
Detailed Description | The purpose of this study is to understand patient preferences for communication and decision-making for advanced breast cancer. The investigators want to better understand what topics the participant wants their doctors and nurses to address with the participant in clinic, and the investigators want to evaluate whether asking patients to fill out a brief survey about their goals and preferences for care and giving this survey to their clinician before the next visit is a good idea that helps to improve communication and decision-making in breast cancer care. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research | ||||
Condition ICMJE | Breast Cancer | ||||
Intervention ICMJE | Other: IGCDG
The IGCDG reviews topics of concern for patients with metastatic breast cancer. | ||||
Study Arms ICMJE | Experimental: Survey QOL
Intervention: Other: IGCDG | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Actual Enrollment ICMJE | 45 | ||||
Original Estimated Enrollment ICMJE | 40 | ||||
Estimated Study Completion Date ICMJE | November 30, 2020 | ||||
Estimated Primary Completion Date | November 30, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03375827 | ||||
Other Study ID Numbers ICMJE | 17-398 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
| ||||
Responsible Party | Jeffrey Peppercorn, Massachusetts General Hospital | ||||
Study Sponsor ICMJE | Massachusetts General Hospital | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
| ||||
PRS Account | Massachusetts General Hospital | ||||
Verification Date | December 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |