Clinical trial NCT04618809: Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer
Official title: Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Gastric Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
name: Eli Lilly and Company
First posted: 2020-11-06
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 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.

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.

Primary outcomes:
measure: Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment)
timeFrame: 18 Months
measure: Percentage of treatment plan changes. (Count # of treatment changes 2-3 months after comprehensive geriatric assessment. Site coordinators will complete follow-up chart review of each patient to see what, if any, changes were made)
timeFrame: 18 months
Secondary outcomes:
measure: Provider perception (Review of Geriatric Assessment Questionnaire)
timeFrame: 18 months
measure: Fitbit assessed functional status. Fitbit data: step count
timeFrame: 18 months
measure: Fitbit assessed functional status. Fitbit data: distance logged
timeFrame: 18 months
measure: Fitbit assessed functional status. Fitbit data: moderately active, lightly active, and sedentary minute categorization.
timeFrame: 18 months
measure: Fitbit assessed functional status. Fitbit data: floors climbed
timeFrame: 18 months
measure: Fitbit assessed functional status. Fitbit data: calories burned
timeFrame: 18 months
measure: Fitbit assessed functional status. Fitbit data: heart rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References: