An interventional study of Phase 2 Intervention - Geriatric Co-Management in Gastric Cancer, Colon Cancer and Esophageal Cancer, sponsored by Dana-Farber Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Health services research
Among 13 studies in Stomach Neoplasms by Dana-Farber Cancer Institute — 2 open to participants now, 2 under way, none of them phase 3. Stomach Neoplasms · Dana-Farber Cancer Institute.
Among the 13 studies in Stomach Neoplasms by Dana-Farber Cancer Institute, this one has the largest planned enrollment of the 11 interventional ones that give a count, is the only one that started in 2022, is the only one with no phase, and was the 12th registered.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
Browse Stomach Neoplasms studies →2 of the 13 studies in Stomach Neoplasms by Dana-Farber Cancer Institute are open now, in 1 country. Recruiting first, the newest first:
Dana-Farber Cancer Institute · Sites in United States
By country, each count listing its studies:
Of the 702 Stomach Neoplasms studies recruiting now, 375 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 68 take healthy volunteers.
This study: 65 Years and older · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 1 started in 2022.
This study's planned enrollment of 147 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Median enrollment 42 across the 11 interventional studies, 2,556 across the 2 observational. Of the 11 that completed or were terminated, 5 (45%) have results posted.
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Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
1 of the studies in Stomach Neoplasms by Dana-Farber Cancer Institute that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04674267Dana-Farber Cancer InstituteResilience and Equity in Aging, Cancer, and Health (REACH) | 2026-12-31 |
Among the 13 studies in Stomach Neoplasms by Dana-Farber Cancer Institute, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
This research study will be conducted in three phases:
Phase 3 - Expanded Clinical Trial
Phase 1 is composed of three aims and will inform the subsequent two phases:.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Phase 2 Intervention - Geriatric Co-Management
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Dec 2026, 59 months after the start.
Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 59 months is above that.
Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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