Resilience and Equity in Aging, Cancer, and Health (REACH)
REACH
1 other identifier
interventional
257
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable gastric-cancer
Started Jan 2022
Longer than P75 for not_applicable gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedStudy Start
First participant enrolled
January 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 18, 2026
March 1, 2026
5 years
December 14, 2020
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool)
EFA questionnaire deployed to older adult patients age 70+ in the REACH study. Feasibility will be determined by the proportion of participants who consent to complete the electronic fitness assessment. The intervention will be considered feasible if 70% of participants consent to complete the fitness assessment.
1 year
Acceptability of electronic fitness assessment questionnaire
Acceptability of electronic fitness assessment questionnaire via the Patient Portal or internet-enabled device following second clinic visit among older adults diagnosed with gastrointestinal cancer seeking consultation at DF/BWCC for medical, radiation, or surgical oncology. Acceptability will be determined by the proportion of participants who fully complete the EFA. The intervention will be considered acceptable if 60% of enrolled participants fully complete the EFA within 14 days of enrollment.
1 year
Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants
Association of geriatrician consult with number of ED visits/hospitalizations among older adults diagnosed with gastrointestinal cancer randomized to the geriatric consultation intervention. Randomization will be essential to evaluate the efficacy of geriatric consultation intervention in impacting unplanned ED visits and hospitalizations.
1 year
Study Arms (2)
Intervention Phase - Geriatric Co-Management
EXPERIMENTALEligible older adults age 70 and older who score "Pre-Frail" or "Frail" will be randomized 2:1 to be offered to meet with a study geriatrician for geriatric co-management in addition to their standard oncology care. Study geriatrician will assist with management of symptoms, additional comorbidities, polypharmacy, and social/emotional concerns in addition to physical care. Geriatrician can make referrals and recommendations for additional supportive services that may be beneficial for more vulnerable older adult patients.
Intervention Phase - Standard Oncology Care
NO INTERVENTIONThis arm is for those older adult patients (age 70+) who score as "Pre-Frail" or "Frail" in the fitness assessment questionnaire and are NOT randomized to meet with the study geriatrician. These patients will be followed for the duration of the study as they proceed with their usual oncology care. Study team will evaluate a number of different measures and outcomes, the primary one being unplanned emergency and hospital visits during the course of the study.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadine J McCleary, MD, MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 14, 2020
First Posted
December 19, 2020
Study Start
January 18, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication.
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.