Resilience and Equity in Aging, Cancer, and Health (REACH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phase 2 Intervention - Geriatric Co-Management.
- Who it may be relevant to
- Registry conditions: Gastric Cancer, Colon Cancer, Esophageal Cancer, Rectal Cancer. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
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.
Interventions
- Other Phase 2 Intervention - Geriatric Co-Management
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.
Primary outcome measures
- Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool) [Time frame: 1 year]
- Acceptability of electronic fitness assessment questionnaire [Time frame: 1 year]
- Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants [Time frame: 1 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT04674267 · 20-275