Geriatric Co-Management for Gastrointestinal Cancer

(REACH Trial)

Overseen By Nadine J. McCleary, MD, MPH

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Under 70, Non-English/Spanish, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

257 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this multi-phase research study is to understand how consultation of cancer care with a geriatrician can best improve outcomes for older adults with gastrointestinal malignancies.

Research Team

Nadine J McCleary, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

Continuing care at DF/BWCC beyond initial consult visit

I have been diagnosed with a type of gastrointestinal cancer.

I can speak English or Spanish.

Exclusion Criteria

Patient who are not considered appropriate for enrollment due to complex medical, social, or other situation as determined by their primary oncology team.

Participants with psychiatric illness/social situations that would limit compliance with study requirements.

Patients who are not continuing care at DF/BWCC beyond first consult visit.

Timeline

Phase 1 - Needs Assessment and Implementation Plan

Evaluate perceived needs, refine implementation plan, and determine characteristics associated with ED visits/hospitalization.

Not specified

Phase 2 - Pilot Intervention

Participants complete an electronic fitness assessment and those scoring 'Pre-frail' or 'Frail' are randomized for geriatric co-management.

1 year

Initial consult visit, followed by ongoing care

Phase 3 - Expanded Clinical Trial

Expanded trial to further evaluate the intervention's impact on unplanned ED visits and hospitalizations.

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment.

1 year

Treatment Details

Interventions

• Geriatric Co-Management

Trial Overview 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.

Participant Groups

Group I: Intervention Phase - Geriatric Co-Management Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+