NCT03007641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

2.5 years

First QC Date

December 20, 2016

Last Update Submit

February 27, 2020

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Provider perception

    18 months

Study Arms (1)

Provider Didactic Intervention

EXPERIMENTAL

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.

Behavioral: Didactic sessionBehavioral: Comprehensive Geriatric Assessment

Interventions

Didactic sessionBEHAVIORAL

This session will include an overview of the approach to and management of older MBC patients through a case-based presentation.

Provider Didactic Intervention
Comprehensive Geriatric AssessmentBEHAVIORAL

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.

Provider Didactic Intervention

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No evidence of MBC
  • Inability to read and understand English
  • Not on active therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

AtlantiCare Cancer Care Institute

Egg Harbor, New Jersey, 08234, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Pottstown Memorial Medical Center

Pottstown, Pennsylvania, 19464, United States

Location

Confluence Health

Wenatchee, Washington, 98801, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 2, 2017

Study Start

November 1, 2016

Primary Completion

April 23, 2019

Study Completion

April 23, 2019

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

US(5)