Recruiting

Geriatric Assessment

Sponsor:

Fox Chase Cancer Center

Code:

NCT04618809

Conditions

Metastatic Gastric Cancer

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Didactic Session

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

Study Details

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

Study ID

NCT04618809

Start date

Sep 22, 2020

Status verified date

Feb, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

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.

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.

Primary outcome measure

  • Number of geriatric abnormalities detected. (Tool used: Comprehensive Geriatric Assessment) [ Time Frame: 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) [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Efrat Dotan, MD

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

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Efrat Dotan, MD

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

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

Feb 15, 2023

Last verified

Feb, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2023-02-15.