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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,613 Previous Clinical Trials

3,200,829 Total Patients Enrolled

Fox Chase Cancer CenterLead Sponsor

227 Previous Clinical Trials

37,409 Total Patients Enrolled

National Comprehensive Cancer NetworkNETWORK

115 Previous Clinical Trials

7,535 Total Patients Enrolled

Media Library

Didactic Session Clinical Trial Eligibility Overview. Trial Name: NCT04618809 — N/A

Gastric Cancer Research Study Groups: Provider Didactic Intervention

Gastric Cancer Clinical Trial 2023: Didactic Session Highlights & Side Effects. Trial Name: NCT04618809 — N/A

Didactic Session 2023 Treatment Timeline for Medical Study. Trial Name: NCT04618809 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have signed up to participate in the research project?

"Affirmative. Clinicaltrials.gov confirms that this study, which was originally posted on September 22nd 2020, is currently seeking participants. The requirement stands for 100 individuals to be enrolled across 2 locations."

Answered by AI

Are there any available openings for participants in this trial?

"Affirmative. Clinicaltrials.gov reveals that this investigation, which was initially posted on September 22nd 2020, is actively recruiting patients. Approximately 100 individuals need to be recruited from 2 distinct hospitals."

Answered by AI

What objectives is this experiment seeking to accomplish?

"According to the trial's sponsor, Eli Lilly and Company, their primary aim is to measure changes in treatment plans within an 18-month time frame. To achieve this they will count the number of treatment alterations made two or three months after a comprehensive geriatric assessment has been performed. Additionally, Fitbit data such as floors climbed, calories burned and step count will be evaluated against physician-recorded performance status scores and functional assessments determined by CGA (Timed Up and Go tests; Activities of Daily Living; Instrumental Activities of Daily Living; falls in past 6 months)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Efrat Dotan 2020. "Improving the Approach to and Management of the Older Patient With Metastatic Gastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04618809.

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