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Geriatric Co-Management for Gastrointestinal Cancer (REACH Trial)

N/A

Recruiting

Led By Nadine J McCleary, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Diagnosed with a gastrointestinal cancer, including: cancers of the esophagus, stomach, pancreas, liver, bile duct, ampulla, colon, rectum, or anus, as well as neuroendocrine tumors.

Patients who are age 70+ at time of initial consult at DF/BWCC

Must not have

Patients less than age 70 at time of initial consultation appointment with DF/BWCC.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how cancer care consultation with a geriatrician can improve outcomes for older adults with gastrointestinal malignancies.

Who is the study for?

This trial is for adults aged 70 or older who have been diagnosed with gastrointestinal cancers such as esophageal, stomach, pancreatic, liver, bile duct, ampulla, colon, rectum or anus cancer. They must be continuing care at DF/BWCC and speak English or Spanish.

What is being tested?

The REACH study is testing the effectiveness of geriatric co-management in improving health outcomes for elderly patients with various types of gastrointestinal cancers during their treatment process.

What are the potential side effects?

Since this trial involves management strategies rather than drugs or medical procedures directly affecting the body's biology, there are no direct side effects associated with traditional clinical interventions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of gastrointestinal cancer.

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I am 70 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 70 years old at my first appointment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability of electronic fitness assessment questionnaire

Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants

Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Phase - Geriatric Co-ManagementExperimental Treatment1 Intervention

Eligible older adults age 70 and older who score "Pre-Frail" or "Frail" will be randomized 2:1 to be offered to meet with a study geriatrician for geriatric co-management in addition to their standard oncology care. Study geriatrician will assist with management of symptoms, additional comorbidities, polypharmacy, and social/emotional concerns in addition to physical care. Geriatrician can make referrals and recommendations for additional supportive services that may be beneficial for more vulnerable older adult patients.

Group II: Intervention Phase - Standard Oncology CareActive Control1 Intervention

This arm is for those older adult patients (age 70+) who score as "Pre-Frail" or "Frail" in the fitness assessment questionnaire and are NOT randomized to meet with the study geriatrician. These patients will be followed for the duration of the study as they proceed with their usual oncology care. Study team will evaluate a number of different measures and outcomes, the primary one being unplanned emergency and hospital visits during the course of the study.

0 / 3Eligibility criteria met