Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient

Metastatic Breast Cancer Clinical Trial

Official title:

Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient Via a Provider Didactic Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03007641
• Other study ID #: 16-8003
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: April 23, 2019

Study information

• Verified date: February 2020
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 23, 2019
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Behavioral:
• Didactic session
This session will include an overview of the approach to and management of older MBC patients through a case-based presentation.
• Comprehensive Geriatric Assessment
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.

Locations

Country	Name	City	State
United States	Bozeman Deaconess Hospital	Bozeman	Montana
United States	AtlantiCare Cancer Care Institute	Egg Harbor Township	New Jersey
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Pottstown Memorial Medical Center	Pottstown	Pennsylvania
United States	Confluence Health	Wenatchee	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Comprehensive Cancer Network, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	18 months
Primary	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.	18 months
Secondary	Provider perception	Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire.	18 months