Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

* 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.

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

Didactic Session

* 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.

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

Efrat Dotan, MD

Juhi Mittal, MD

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.

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.

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

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%.

The Comprehensive Geriatric Assessment includes the following scales:

Eastern Cooperative Oncology Group Performance Status, Self-rated Performance Status, Katz Activities of Daily Living scale, Lawton Instrumental Activities of Daily Live Scale, Timed Up and Go, Number of Falls in past 6 months, Medical Social Support Scale, Geriatric Depression Scale, National Comprehensive Cancer Center Distress Thermometer, Blessed Orientation Memory Concentration Scale, Charlson Comorbidity Index, Body Mass index,Mini Nutritional Assessment, Cancer and Aging Research Group Chemotherapy Toxicity Prediction Calculator, Comprehensive Score for Financial Toxicity - Functional Assessment of Chronic Illness Therapy scale

Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.

Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire

We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between step count, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.

We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.

We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between distance logged, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.

We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.

We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between moderately active, lightly active, and sedentary minute categorization, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.

We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.

We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between floors climbed, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.

We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.

We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between calories burned, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.

We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.

We aim to determine the feasibility of using fitbits in this patient population and evaluate the correlation between heart rate, physician recorded performance status, and scores on functional assessment in the comprehensive geriatric assessment.

We will compare data collected from the FitBit to both the physician-reported and CGA-identified functional status (Timed Up and Go, Activities of Daily Living, Instrumental Activities of Daily Living, and number of falls in the past 6 months) in each patient.

National Comprehensive Cancer Network

Eli Lilly and Company

Fox Chase Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

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

Didactic session

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.

Comprehensive Geriatric Assessment

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.

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.

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

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

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%.

Measurement of provider perception of the efficacy and feasibility of the didactic educational session via questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer	NCT04618809	Metastatic Gast...	Didactic Sessio... Comprehensive G...	70 Years -	Fox Chase Cancer Center
Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient	NCT03007641	Metastatic Brea...	Didactic sessio... Comprehensive G...	70 Years -	Fox Chase Cancer Center

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