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

NCT03007641

Last updated date
Study Location
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
70 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- No evidence of MBC


- Inability to read and understand English


- Not on active therapy

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Advanced Information
Descriptive Information
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:

  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.

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
  • Behavioral: Didactic session
    This session will include an overview of the approach to and management of older MBC patients through a case-based presentation.
  • Behavioral: 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.
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:
  • Behavioral: Didactic session
  • Behavioral: Comprehensive Geriatric Assessment
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
 (submitted: February 27, 2020)
100
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2016)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • National Comprehensive Cancer Network
  • Pfizer
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