Resilience and Equity in Aging, Cancer, and Health (REACH)

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Esophageal Cancer; Gastric Cancer; Gastrointestinal Cancer; Colon Cancer; Pancreatic Cancer; Rectal Cancer

Treatments: Other: Phase 2 Intervention - Geriatric Co-Management

Study type: Interventional

Funder types: Other

Identifiers

NCT04674267

20-275

Details and patient eligibility

About

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.

Full description

This research study will be conducted in three phases:

• Phase 1 - Needs assessment and implementation plan

• Phase 2 - Pilot Intervention

• Phase 3 - Expanded Clinical Trial

  • Please note Phase 2 - Pilot Intervention and Phase 3 - Expanded Clinical Trial will be added to the clinicaltrials.gov record once Institutional Review Board (IRB) approved.

Phase 1 is composed of three aims and will inform the subsequent two phases:.

• Aim 1: To evaluate the perceived needs of Older Adults diagnosed with gastrointestinal malignancies, caregivers, staff, and faculty to characterize the implementation setting for a geriatric consultation.
• Aim 2: To refine the proposed REACH program implementation plan based on qualitative feedback provided by Older Adult (OA) patients, their identified caregivers, staff, and faculty.
• Aim 3: Determine the patient, demographic, social determinants, clinical and disease characteristics of Older Adults (OA) associated with ED visits/hospitalization following initial oncology consultation at DF/BWCC in year 2019.
• Phase 2 intervention has started as of January 2022 following IRB approval. Study team has begun recruiting participants into Phase 2 intervention of REACH study starting in January 2022. Participants approached by REACH coordinator for consenting and enrollment after their initial consult visit at Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC). Participants are then asked to complete an electronic fitness assessment (EFA) that is sent to them via Patient Gateway. Participants complete this questionnaire and receive a score of "Robust", "Pre-frail", or "Frail" - those who score "Pre-frail" or "Frail" will be randomized to meet with a study geriatrician for geriatric co-management intervention alongside their standard oncology care. All enrolled participants will be followed for a duration of 1 year as they are continuing care at DF/BWCC.

Enrollment: 147 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are age 65+ at time of initial consult at DF/BWCC
• 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.
• Continuing care at DF/BWCC beyond initial consult visit

Exclusion criteria

• Patients less than age 65 at time of initial consultation appointment with DF/BWCC.
• Patients who are not continuing care at DF/BWCC beyond first consult visit.
• Not proficient in English, Spanish, Haitian Creole, Portuguese, Traditional Chinese, Arabic, or Russian
• 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

147 participants in 2 patient groups

Intervention Phase - Geriatric Co-Management

Experimental group

Description:

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.

Treatment:

Other: Phase 2 Intervention - Geriatric Co-Management

Intervention Phase - Standard Oncology Care

No Intervention group

Description:

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.