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NCT04674267 | RECRUITING | Gastric Cancer


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

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Nadine McCleary, MD, MPH

Brief 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.

Condition or disease

Gastric Cancer

Colon Cancer

Esophageal Cancer

Rectal Cancer

Pancreatic Cancer

Gastrointestinal Cancer

Intervention/treatment

Phase 2 Intervention - Geriatric Co-Management

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 257 participants
Masking : NONE
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : 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
Actual Study Start Date : 2022-01-18
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT04674267


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How to Participate

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Locations


RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

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