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

NCT04618809 | Unknown

• 1 other identifier: 20-8006
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment)

  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

  18 Months

• 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)

  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 (7)

• Provider perception (Review of Geriatric Assessment Questionnaire)

  18 months

• Fitbit assessed functional status. Fitbit data: step count

  18 months

• Fitbit assessed functional status. Fitbit data: distance logged

  18 months

• Fitbit assessed functional status. Fitbit data: moderately active, lightly active, and sedentary minute categorization.

  18 months

• Fitbit assessed functional status. Fitbit data: floors climbed

  18 months

Study Arms (1)

Provider Didactic Intervention

EXPERIMENTAL

* 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.

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

Interventions

Didactic Session BEHAVIORAL

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

Provider Didactic Intervention

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

Provider Didactic Intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Ability to read and understand English, ability to sign consent, and complete a self-assessment evaluation.
• Evidence of mGC (mGE junction cancer allowed). Patients can be enrolled at any stage of their treatment or disease course.
• Ongoing active therapy for mGC. Patients can be treated with any type of therapy including chemotherapy, immunotherapy or Her-2 targeted therapy.
• Life expectancy ≥3 months.

You may not qualify if:

• ≤69 years old.
• Inability to read and understand English.
• No evidence of mGC.
• Not on active therapy.
• Life expectancy \<3 months.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Comprehensive Cancer Network: collaborator
• Eli Lilly and Company: collaborator

Study Sites (2)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Efrat Dotan, MD

CONTACT

215-214-4283; Efrat.Dotan@fccc.edu

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: PRINCIPAL INVESTIGATOR
• PI Title: Efrat Dotan, MD

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: September 22, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (2)