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Geriatric Assessment + Fitness Trackers for Gastric Cancer

N/A

Recruiting

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trialaims to improve care for older metastatic gastric cancer patients by increasing awareness of unique needs & assessing feasibility of geriatric self-assessments.

Who is the study for?

This trial is for English-speaking adults aged 70 or older with metastatic gastric cancer (including mGE junction cancer), who are currently undergoing any form of active therapy such as chemotherapy, immunotherapy, or Her-2 targeted therapy. They should be able to give consent and complete self-assessments, with a life expectancy of at least three months.

What is being tested?

The study aims to improve care for older patients with metastatic gastric cancer by educating oncology providers on geriatric assessments' role in treatment guidance. It will explore the use of fitness trackers to evaluate functional status and incorporate geriatric self-assessments into clinical practice over four phases.

What are the potential side effects?

Since this trial focuses on educational sessions and assessments rather than new medications, side effects may not be directly related to interventions. However, participants might experience discomfort or fatigue from completing assessments or wearing fitness trackers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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)

Secondary study objectives

Fitbit assessed functional status. Fitbit data: calories burned

Fitbit assessed functional status. Fitbit data: distance logged

Fitbit assessed functional status. Fitbit data: floors climbed

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Provider Didactic InterventionExperimental Treatment2 Interventions

* 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.

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