Clinical trial · Interventional
Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer
A Geriatric Assessment Intervention for Patients Aged 70 and Over Receiving Chemotherapy or Similar Agents for Advanced Cancer: Reducing Toxicity in Older Adults
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This cluster randomized clinical trial compares a geriatric assessment intervention with usual care for reducing cancer treatment toxicity in older patients with cancer that has spread to other places in the body. A geriatric assessment may identify risk factors for cancer treatment toxicity and may improve outcomes for older patients with advanced cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Solid Neoplasm | Adult Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Geriatric Assessment | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (GA intervention)
- description
- Patients complete a geriatric assessment. Patients and physicians are provided with the geriatric assessment information and recommendations.
- interventionNames
- Other: Comprehensive Geriatric Assessment
- Other: Quality-of-Life Assessment
- Other: Survey Administration
- type
- NO_INTERVENTION
- label
- Arm II (usual care)
- description
- Patients complete a geriatric assessment, but information other than clinically significant cognitive impairment and depression is not provided to the oncology teams.
Primary outcomes (1)
- measure
- Patient Experienced Any Grade 3-5 Toxicity
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * INCLUSION CRITERIA FOR PHYSICIANS * Oncology physicians must work at a National Cancer Institute (NCI) Community Oncology Research Program (NCORP) practice site with no plans to leave that NCORP practice site or retire at the time of enrollment into the study * INCLUSION CRITERIA FOR PATIENTS * Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma; in most situations, this would be a stage IV cancer; patients with a diagnosis of stage III cancer or lymphoma are eligible if cure is not possible or anticipated; clinical staging without pathological confirmation of advanced disease is allowed * Plan to start a new cancer treatment regimen within 4 weeks from time of baseline registration; the treatment regimen is up to the discretion of the treating oncology physician; the regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity; patients who will receive monoclonal antibody therapy or other cancer therapies (e.g., tyrosine kinase inhibitors) are eligible if other agents present a prevalence of toxicity similar to chemotherapy; patients who are receiving approved cancer treatment in combination with radiation are eligible; a patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met. \*Chemotherapy is defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) that have a prevalence of grade 3-5 toxicity in older patients similar to chemotherapy (\>50%) will be allowed. * Plan to be on chemotherapy or other allowable treatment for at least 3 months (minimum 70 days) and be willing to come in for study visits * Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy * Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit. If the participant is found to be impaired on the Blessed-Orientation Memory Concentration Test (BOMC) during screening; they must have a health care proxy or authorized representative to be eligible to enroll. * Participant has adequate understanding of the English language Exclusion Criteria: * EXCLUSION CRITERIA FOR PATIENTS * Have surgery planned within 3 months of consent; patients who have previously received surgery are eligible * Presence of symptomatic brain metastases at time of study consent process. Patients with a history of treated brain metastases are eligible if they are not symptomatic at the time of study enrollment.
References
Publications (16)
- DERIVEDMohamed MR, Rich DQ, Lund JL, Seplaki CL, Flannery M, Alieldin R, Chen Y, Ramsdale E, Wells M, Magnuson A, Loh KP, Dunne R, Janelsins M, Mohile S. Treatment Tolerability in Older Adults With Advanced Cancer Receiving Geriatric Assessment-Guided Versus Oncologist-Guided Primary Treatment Modification: Secondary Analysis of the GAP70+ Trial. JCO Oncol Pract. 2026 Jul 24:OP2501364. doi: 10.1200/OP-25-01364. Online ahead of print. PMID 42497369
- DERIVEDRichardson DR, Wang Y, Flannery M, Mohamed M, Magnuson A, Wells M, Tylock R, Soto-Perez-de-Celis E, DuMontier C, Dale W, Epstein R, Berenberg J, Ramdin N, Mohile S, Loh KP. Outcomes of Older Adults With Advanced Cancer Who Prefer Quality of Life vs Prolonging Survival: A Secondary Analysis of the GAP70+ Cluster Randomized Clinical Trial. JAMA Oncol. 2026 May 1;12(5):517-521. doi: 10.1001/jamaoncol.2026.0072. PMID 41784985
- DERIVEDHryniv S, Gilbride E, Consagra W, Mohile S, Yilmaz S, Kyi K, Kadambi S, Jensen-Battaglia M, Gilmore N, Whitehead M, Khatri J, Braiteh FS, Conlin A, Loh KP, Magnuson A. Exploring decisional control preferences in older patients with cancer and their caregivers. J Geriatr Oncol. 2026 Mar;17(2):102832. doi: 10.1016/j.jgo.2025.102832. Epub 2025 Dec 12. PMID 41389716
- DERIVEDFlannery MA, Zhang Z, Culakova E, Loh KP, Canin B, Tylock RG, Stauffer FA, Mohamed M, Sun H, Mohile S. Decision regret in older adults with advanced cancer receiving systemic therapy: Associations with patient-reported and clinician-rated tolerability metrics. Cancer. 2025 Oct 15;131 Suppl 2(Suppl 2):e70023. doi: 10.1002/cncr.70023. PMID 41123568
- DERIVEDJensen-Battaglia M, Delmerico A, Mohamed M, Tylock R, Flannery M, Burnette BL, Desai N, Anthony N, Mustian K, Loh KP, Mohile SG, Seplaki CL, Gilmore N. Fatigue, physical function, and the context of social vulnerability for older adults with cancer. J Geriatr Oncol. 2025 Jul;16(6):102284. doi: 10.1016/j.jgo.2025.102284. Epub 2025 May 31. PMID 40450795
- Ramsdale E, Zhou Y, Smith L, Xu H, Tylock R, Flannery M, Mohile S, Anand A. Unsupervised learning to identify symptom clusters in older adults undergoing chemotherapy. J Geriatr Oncol. 2025 Apr;16(3):102222. doi: 10.1016/j.jgo.2025.102222. Epub 2025 Mar 14.