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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if working with a geriatrician (a doctor specializing in older adults) can improve cancer care for older adults with gastrointestinal cancers, such as those of the stomach or colon. Participants will receive either standard cancer care or additional consultations with a geriatrician to manage symptoms and other health issues. Suitable candidates for this trial are individuals aged 70 and older, diagnosed with a gastrointestinal cancer, and facing challenges like managing multiple health issues or medications. As an unphased trial, this study offers participants the opportunity to contribute to research that could enhance cancer care for older adults.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that geriatric co-management is safe for older adults with gastrointestinal cancer?

Research has shown that geriatric co-management can be a safe option for older adults, particularly those with gastrointestinal cancers. In studies, older patients who received this extra care had a lower chance of dying within 90 days after surgery—4.3% compared to 8.9% for those who did not receive it.

While some risks exist, such as surgical complications (25.5%) and delirium (confusion, 21.7%), the main goal is to better manage symptoms and other health issues with the help of a geriatrician. This approach can improve care for older adults by addressing their physical and emotional needs. Overall, geriatric co-management is a well-tolerated method that focuses on improving patient outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Geriatric Co-Management approach for older adults with gastrointestinal cancer because it takes a holistic view of patient care. Unlike standard oncology treatments that focus primarily on cancer itself, this method incorporates a geriatrician who addresses additional factors like symptoms management, comorbidities, and polypharmacy. This personalized care can potentially reduce unplanned hospital visits by tackling social and emotional concerns, leading to a more comprehensive support system for vulnerable older patients.

What evidence suggests that geriatric co-management is effective for improving outcomes in older adults with gastrointestinal cancer?

Research has shown that involving geriatric care benefits older adults with gastrointestinal cancer. In this trial, participants will be divided into two groups: one will receive geriatric co-management alongside standard oncology care, while the other will continue with standard oncology care alone. One study found that geriatric care improved outcomes for older patients undergoing surgery for this type of cancer by managing frailty and reducing post-surgery complications. Another study suggested that geriatric assessments can predict survival and help patients complete their treatments, although these assessments can be complex to carry out. Overall, adding geriatric care to cancer treatment appears promising in supporting older patients by addressing their specific health needs. ^{3 6 7 8 9}

Who Is on the Research Team?

Nadine J McCleary, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12468265/

Implementation and Outcomes of a Perioperative Geriatrics ... The most common complications observed were surgical complications (25.5%), delirium (21.7%), and functional decline (19.8%). Studies of ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e24015

Evaluating embedded geriatric care in gastrointestinal (GI) ... Geriatric assessment can predict survival, toxicity, and completion of planned therapy but has been considered cumbersome for use in oncology practice.

3. jamda.com jamda.com/article/S1525-8610(22)00298-5/abstract

Effect of Geriatric Comanagement in Older Patients ... To determine the effect of geriatric comanagement on clinical outcomes of older patients undergoing surgery for gastrointestinal cancer.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666756822001696

Articles Integrated Geriatric Assessment and Treatment ... The effectiveness of comprehensive geriatric assessment (CGA) in improving health outcomes in cancer settings is unclear.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9831909/

Frailty and surgical outcomes in gastrointestinal cancer A growing body of research has shown associations of frailty with adverse postoperative outcomes and poor prognosis after resection of gastrointestinal tract.

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.796

Systemic anti-cancer therapy in older patients with ... Informed treatment recommendations are made using CGA outcomes and risk assessed using the Cancer and Aging Research Group toxicity calculator.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2059702922003957

Geriatric assessment and the variance of treatment ... Geriatric assessment and the variance of treatment recommendations in geriatric patients with gastrointestinal cancer—a study in AIO oncologists. Author ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021024/

The Association between Social Vulnerability and Geriatric ... We included 908 older adults ≥60y recently diagnosed with GI cancer undergoing GA at first pre-chemotherapy visit to UAB oncology clinic.

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2769503

Geriatric Comanagement and 90-Day Postoperative ... The adjusted probability of death within 90 days after surgery was 4.3% for patients who received geriatric comanagement of care, compared with 8.9% for ...