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

Study Overview
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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.

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.

Official Title
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Resilience and Equity in Aging, Cancer, and Health (REACH): Promoting Physical Resilience and Cancer Care Equity for Adults Age 70 and Older Diagnosed With Gastrointestinal Malignancy

Conditions
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Gastric Cancer, Colon Cancer, Esophageal Cancer, Rectal Cancer, Pancreatic Cancer, Gastrointestinal Cancer

Intervention / Treatment
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* Other: Phase 2 Intervention - Geriatric Co-Management


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Phase - Geriatric Co-Management<br>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. | Other: Phase 2 Intervention - Geriatric Co-Management<br>* 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.<br>|
| No Intervention: Intervention Phase - Standard Oncology Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool) | EFA questionnaire deployed to older adult patients age 70+ in the REACH study. Feasibility will be determined by the proportion of participants who consent to complete the electronic fitness assessment. The intervention will be considered feasible if 70% of participants consent to complete the fitness assessment. | 1 year | 
| Acceptability of electronic fitness assessment questionnaire | Acceptability of electronic fitness assessment questionnaire via the Patient Portal or internet-enabled device following second clinic visit among older adults diagnosed with gastrointestinal cancer seeking consultation at DF/BWCC for medical, radiation, or surgical oncology. Acceptability will be determined by the proportion of participants who fully complete the EFA. The intervention will be considered acceptable if 60% of enrolled participants fully complete the EFA within 14 days of enrollment. | 1 year | 
| Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants | Association of geriatrician consult with number of ED visits/hospitalizations among older adults diagnosed with gastrointestinal cancer randomized to the geriatric consultation intervention. Randomization will be essential to evaluate the efficacy of geriatric consultation intervention in impacting unplanned ED visits and hospitalizations. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal cancer