Esophageal Cancer Clinical Trial

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

Summary

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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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.

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Eligibility Criteria

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.

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

257

Study ID:

NCT04674267

Recruitment Status:

Recruiting

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Nadine J McCleary, MD, MPH
Contact
877-442-3324
[email protected]
Nadine J McCleary, MD, MPH
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

257

Study ID:

NCT04674267

Recruitment Status:

Recruiting

Sponsor:


Dana-Farber Cancer Institute

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