Clinical trial NCT04674267: Resilience and Equity in Aging, Cancer, and Health (REACH)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Colon Cancer
Esophageal Cancer
Rectal Cancer
Pancreatic Cancer
Gastrointestinal Cancer
Keywords: Gastrointestinal cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 257
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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.

Primary outcomes:
measure: Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool)
timeFrame: 1 year
measure: Acceptability of electronic fitness assessment questionnaire
timeFrame: 1 year
measure: Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Nadine J McCleary, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: