Gastric CancerREACHNCT04674267

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

A study testing Phase 2 Intervention - Geriatric Co-Management in people with Gastric Cancer and Colon Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Gastric Cancer, Colon Cancer, Esophageal Cancer
What is being tested?: Phase 2 Intervention - Geriatric Co-Management
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 1 siteUnited States
Study dates: 18 Jan 2022to 31 Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Patients who are age 65+ 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

Who cannot join

Patients less than age 65 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, Spanish, Haitian Creole, Portuguese, Traditional Chinese, Arabic, or Russian
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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nadine A Jackson, MD, MPH contact

877-442-3324

NA_Jackson@dfci.harvard.edu

Nadine J McCleary, MD, MPH contact

877-442-3324

NJ_McCleary@dfci.harvard.edu

United States1 site, 1 recruiting

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Nadine J McCleary, MD, MPH, 877-442-3324, NJ_McCleary@dfci.harvard.edu
Nadine J McCleary, MD, MPH
Recruiting

Other trials in United States

About this study

Official title: Resilience and Equity in Aging, Cancer, and Health (REACH): Promoting Physical Resilience and Cancer Care Equity for Adults Age 65 and Older Diagnosed With Gastrointestinal Malignancy

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.

Read the 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.

Conditions: Gastric Cancer, Colon Cancer, Esophageal Cancer, Rectal Cancer, Pancreatic Cancer, Gastrointestinal Cancer
Being tested: Phase 2 Intervention - Geriatric Co-Management
Keywords: Gastrointestinal cancer
Medical subject headings: Stomach Neoplasms, Colonic Neoplasms, Esophageal Neoplasms, Rectal Neoplasms, Pancreatic Neoplasms, Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Phase 2 Intervention - Geriatric Co-ManagementOther
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.

Study groups in NCT04674267
Study group	Role	What they receive
Intervention Phase - Geriatric Co-Management	Experimental	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. Receives: Other: Phase 2 Intervention - Geriatric Co-Management
Intervention Phase - Standard Oncology Care	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 202231 Dec 2026

First posted19 Dec 2020
Study start18 Jan 2022
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 147 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04674267
Sponsor's protocol ID: 20-275
Acronym: REACH
Status last verified: Mar 2026
First submitted: 14 Dec 2020
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Resilience and Equity in Aging, Cancer, and Health (REACH): Promoting Physical Resilience and Cancer Care Equity for Adults Age 65 and Older Diagnosed With Gastrointestinal Malignancy
ClinicalTrials.gov ID: NCT04674267
Acronym / sponsor ID: REACH / 20-275
Conditions: Gastric Cancer, Colon Cancer, Esophageal Cancer, Rectal Cancer, Pancreatic Cancer, Gastrointestinal Cancer
Keywords: Gastrointestinal cancer
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 147 participants (estimated)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Study start: 18 Jan 2022 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 19 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention Phase - Geriatric Co-Management	Experimental	Other: Phase 2 Intervention - Geriatric Co-ManagementEligible 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 intervention	–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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Patients who are age 65+ 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

Key exclusion criteria (5 listed)

Patients less than age 65 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, Spanish, Haitian Creole, Portuguese, Traditional Chinese, Arabic, or Russian
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Phase 2 Intervention - Geriatric Co-ManagementParticipants 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.	Other	Intervention Phase - Geriatric Co-Management

Primary outcome

Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool)
Time frame: 1 year
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.
Acceptability of electronic fitness assessment questionnaire
Time frame: 1 year
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.
Association of geriatric consultation with number of unplanned ED visits/hospitalizations among older adult participants
Time frame: 1 year
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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Nadine A Jackson, MD, MPH contact

877-442-3324

NA_Jackson@dfci.harvard.edu

Nadine J McCleary, MD, MPH contact

877-442-3324

NJ_McCleary@dfci.harvard.edu

Nadine A Jackson, MD, MPH principal investigator

Dana-Farber Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Phase 2 Intervention - Geriatric Co-Management in people with Gastric Cancer and Colon Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nadine A Jackson, MD, MPH (877-442-3324, NA_Jackson@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of electronic fitness assessment questionnaire (developed from Comprehensive Geriatric Assessment tool) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04674267.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.