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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Cancer Colon Cancer Esophageal Cancer Rectal Cancer Pancreatic Cancer Gastrointestinal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention Phase - Geriatric Co-Management

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 Type EXPERIMENTAL

Phase 2 Intervention - Geriatric Co-Management

Intervention Type OTHER

Participants will complete an electronic fitness assessment questionnaire - once completed, they will receive a score of "Robust", "Pre-Frail" or "Frail". Those who are "Pre-frail" or "Frail" will be randomized to meet with a study geriatrician for geriatric co-management in addition to usual oncology care. All participants will be followed for a duration of 1 year.

Intervention Phase - Standard Oncology Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Phase 2 Intervention - Geriatric Co-Management

Participants will complete an electronic fitness assessment questionnaire - once completed, they will receive a score of "Robust", "Pre-Frail" or "Frail". Those who are "Pre-frail" or "Frail" will be randomized to meet with a study geriatrician for geriatric co-management in addition to usual oncology care. All participants will be followed for a duration of 1 year.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who are age 70+ 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
* English and Spanish-speaking

Exclusion Criteria

* Patients less than age 70 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 or Spanish
* 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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No