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

NCT04674267 · Dana-Farber Cancer Institute
In plain English

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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
About this study
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.
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 design
Enrollment target: 257 participants
Allocation: randomized
Masking: none
Age groups: older_adult
Timeline
Starts: 2022-01-18
Estimated completion: 2026-12-31
Last updated: 2026-03-18
Interventions
Other: Phase 2 Intervention - Geriatric Co-Management
Primary outcomes
  • Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool) (1 year)
  • Acceptability of electronic fitness assessment questionnaire (1 year)
  • Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants (1 year)
Sponsor
Dana-Farber Cancer Institute · other
Contacts & investigators
ContactNadine J McCleary, MD, MPH · contact · NJ_McCleary@dfci.harvard.edu · 877-442-3324
InvestigatorNadine J McCleary, MD, MPH · principal_investigator, Dana-Farber Cancer Institute
All locations (1)
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Resilience and Equity in Aging, Cancer, and Health (REACH) · TrialPath