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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT04674267
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Nadine J McCleary, MD, MPH
Phone 877-442-3324
Email NJ_McCleary@dfci.harvard.edu
Status Recruiting
Phase N/A
Start date January 18, 2022
Completion date December 31, 2024

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