Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer

NCT ID: NCT04618809

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-22
• Study Completion Date: 2023-12-31

Brief Summary

The purpose of this study is to enhance the care of older metastatic gastric cancer (mGC) patients by increasing awareness among oncology providers of 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 mGC patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four 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 gastric cancer (mGC) 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 mGC patient by increasing awareness among oncology providers of 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 gastric cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include four phases:

1. Needs assessments - to understand the population of older gastric cancer patients seen in routine practice at community and academic centers, and assess their treatment approach.

2. Educational programming about management of older metastatic gastric cancer patients, and geriatric assessment of these patients.

3. Active testing of the use of geriatric assessment in clinical practice, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.

4. Short-term follow-up chart reviews (2-3 months post intervention) to assess for actual implementation of recommended interventions identified by the geriatric assessment.

The ultimate goal is to expand this educational intervention to other oncology practices beyond those participating in this study, and for all older cancer patients regardless of their disease site. During this study period we will identify the specific gaps that exist in each practice for the care of older patients with mGC. This information is crucial to understand the needs of this patient population and will inform future trials with possible intervention. The second phase of our study will expose the practices to the use of a geriatric assessment through a patient's self-assessment tool and demonstrate its feasibility. Our hope is that all involved practices will find benefit from incorporating a geriatric assessment into their practice and will continue to use it in the future.

Conditions

Metastatic Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Provider Didactic Intervention

• Phase 1 - Providers complete a needs assessment questionnaire, which evaluates the approach to older mGC patients at each site.
• Phase 2 - Providers participate in an hour-long didactic session and begin enrolling eligible metastatic gastric cancer (mGC) patients. Enrolled mGC patients complete a comprehensive geriatric assessment (CGA). Providers complete the treatment plan and review of geriatric assessment questionnaires, which also includes an evaluation of their overall view of the utility of the geriatric assessment.
• Phase 3 - Follow-up chart reviews (2-3 months post intervention) are completed to assess for actual implementation of recommended interventions identified by the geriatric assessment.

Group Type: EXPERIMENTAL

Didactic Session

Intervention Type: BEHAVIORAL

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

Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.

Intervention Type: BEHAVIORAL

• 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.
• The patient will receive a FitBit TM to wear for 4 days. Number of steps/day will be recorded.

Interventions

Didactic Session

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

Intervention Type: BEHAVIORAL

Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.

• 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.
• The patient will receive a FitBit TM to wear for 4 days. Number of steps/day will be recorded.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Ability to read and understand English, ability to sign consent, and complete a self-assessment evaluation.

2. Evidence of mGC (mGE junction cancer allowed). Patients can be enrolled at any stage of their treatment or disease course.

3. Ongoing active therapy for mGC. Patients can be treated with any type of therapy including chemotherapy, immunotherapy or Her-2 targeted therapy.

4. Life expectancy ≥3 months.

Exclusion Criteria

1. ≤69 years old.

2. Inability to read and understand English.

3. No evidence of mGC.

4. Not on active therapy.

5. Life expectancy <3 months.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Efrat Dotan

Efrat Dotan, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Efrat Dotan, MD

Role: CONTACT

Efrat.Dotan@fccc.edu

215-214-4283

Facility Contacts

Efrat Dotan, MD

Role: primary

Efrat.Dotan@fccc.edu

215-214-4283

Juhi Mittal, MD

Role: primary

Judi.mittal@tuhs.temple.edu

267-563-1580

Other Identifiers

20-8006

Identifier Type: -

Identifier Source: org_study_id