Recruiting

Resilience & Equity

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04674267

Conditions

Gastric Cancer

Colon Cancer

Esophageal Cancer

Rectal Cancer

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Phase 2 Intervention - Geriatric Co-Management

Study Details

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.

Conditions

Gastric Cancer

Colon Cancer

Esophageal Cancer

Rectal Cancer

Pancreatic Cancer

Study ID

NCT04674267

Start date

Jan 18, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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

257 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention Phase - Geriatric Co-Management

Eligible 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.

no intervention: Intervention Phase - Standard Oncology Care

This 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

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Nadine J McCleary, MD, MPH

877-442-3324NJ_McCleary@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Nadine J McCleary, MD, MPH

877-442-3324NJ_McCleary@dfci.harvard.edu

Principal Investigator:

Nadine J McCleary, MD, MPH

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • Gastrointestinal cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-03-18.