Clinical trial NCT03007641: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
name: Pfizer
First posted: 2017-01-02
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. Needs assessments - to understand the population of older metastatic breast cancer patients seen in routine practice at community centers, and assess their treatment approach.
2. Educational programming about management of older metastatic breast cancer patients, and geriatric assessment of these patients.
3. 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.

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

Primary outcomes:
measure: Number of geriatric abnormalities detected
timeFrame: 18 months
measure: Percentage of treatment plan changes
timeFrame: 18 months
Secondary outcomes:
measure: Provider perception
timeFrame: 18 months
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Bozeman Deaconess Hospital
state: Montana
city: Egg Harbor Township
country: United States
facility: AtlantiCare Cancer Care Institute
state: New Jersey
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Memorial Medical Center
state: Pennsylvania
city: Wenatchee
country: United States
facility: Confluence Health
state: Washington
Study officials:
References: