Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient
NCT03007641
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- Evidence of metastatic breast cancer (MBC)
- Ongoing active therapy for MBC
- Ability to sign informed consent, and complete a self-assessment evaluation.
- Life expectancy >3 months
- No evidence of MBC
- Inability to read and understand English
- Not on active therapy
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Descriptive Information | |||
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Brief Title ICMJE | Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient | ||
Official Title ICMJE | Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient Via a Provider Didactic Intervention | ||
Brief Summary | The purpose of this study is to enhance the care of older metastatic breast cancer (MBC) patients by increasing awareness among oncology providers as to the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older metastatic breast cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include three phases. | ||
Detailed Description | Older oncology patients pose a significant treatment challenge due to poor chemotherapy tolerance as a result of underlying co-morbidities, lack of social support, and diminished functional reserve. Oncologists are faced with the challenge of differentiating between patients that can and cannot tolerate chemotherapy, and tailoring therapy to the patient's biologic rather than chronologic age. A significant challenge that surrounds the treatment of the older metastatic breast cancer (MBC) patient in particular, lies in the lack of evidence based clinical data to guide the oncologist in determination of a treatment plan. This is a result of under representation of older patients in clinical trials. Due to these challenges a thorough evaluation of the older patient is recommended prior to initiation of anti-cancer therapy. The purpose of this research study is to enhance the care of the older MBC patient by increasing awareness among oncology providers as to the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older metastatic breast cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include three phases:
The ultimate goal is to develop an educational curriculum that could be implemented at other community oncology sites beyond the participants on this study. This type of educational intervention can be applied to other disease sites in the future. During the study period we will identify the specific gaps that exist in each practice and develop an educational intervention to match these gaps. Our hope is that all involved practices will benefit from incorporating a geriatric assessment into their practice and will find it feasible to use the tools provided. These data are of high importance to the oncologic community and would be hypothesis-generating for future clinical trials. | ||
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 | Metastatic Breast Cancer | ||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Provider Didactic Intervention
Phase 1 - Providers complete a needs assessment questionnaire. Phase 2 - Providers participate in an hour long didactic session, and begin enrolling eligible metastatic breast cancer (MBC) patients. Enrolled MBC patients complete a comprehensive geriatric assessment (CGA). Providers complete a treatment plan questionnaire and a CGA utility questionnaire. Phase 3 - Providers are administered a final questionnaire evaluating their overall view of this educational intervention. Interventions:
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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 | Completed | ||
Actual Enrollment ICMJE | 100 | ||
Original Estimated Enrollment ICMJE | 150 | ||
Actual Study Completion Date ICMJE | April 23, 2019 | ||
Actual Primary Completion Date | April 23, 2019 (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 | 70 Years and older (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 | NCT03007641 | ||
Other Study ID Numbers ICMJE | 16-8003 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Fox Chase Cancer Center | ||
Study Sponsor ICMJE | Fox Chase Cancer Center | ||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||
PRS Account | Fox Chase Cancer Center | ||
Verification Date | February 2020 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |