Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient
Primary Purpose
Metastatic Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Didactic session
Comprehensive Geriatric Assessment
Sponsored by
About this trial
This is an interventional health services research trial for Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- No evidence of MBC
- Inability to read and understand English
- Not on active therapy
Sites / Locations
- Bozeman Deaconess Hospital
- AtlantiCare Cancer Care Institute
- Fox Chase Cancer Center
- Pottstown Memorial Medical Center
- Confluence Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Provider Didactic Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of geriatric abnormalities detected
Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%.
Percentage of treatment plan changes
Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.
Secondary Outcome Measures
Provider perception
Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire.
Full Information
NCT ID
NCT03007641
First Posted
December 20, 2016
Last Updated
February 27, 2020
Sponsor
Fox Chase Cancer Center
Collaborators
National Comprehensive Cancer Network, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT03007641
Brief Title
Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient
Official Title
Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient Via a Provider Didactic Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
April 23, 2019 (Actual)
Study Completion Date
April 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Comprehensive Cancer Network, Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Needs assessments - to understand the population of older metastatic breast cancer patients seen in routine practice at community centers, and assess their treatment approach.
Educational programming about management of older metastatic breast cancer patients, and geriatric assessment of these patients.
Active testing of the use of geriatric assessment in clinical practice.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Provider Didactic Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Didactic session
Intervention Description
This session will include an overview of the approach to and management of older MBC patients through a case-based presentation.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Geriatric Assessment
Intervention Description
The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy.
Primary Outcome Measure Information:
Title
Number of geriatric abnormalities detected
Description
Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%.
Time Frame
18 months
Title
Percentage of treatment plan changes
Description
Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Provider perception
Description
Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
No evidence of MBC
Inability to read and understand English
Not on active therapy
Facility Information:
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
AtlantiCare Cancer Care Institute
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Pottstown Memorial Medical Center
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
Confluence Health
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient
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