N/A
N=733
Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer
Adult Solid Neoplasm · Toxicity · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02054741 ↗Enrolled (actual)
733
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Patient Experienced Any Grade 3-5 Toxicity — 0.51; 0.71 proportion of participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Comprehensive Geriatric Assessment (Other); Quality-of-Life Assessment (Other); Survey Administration (Other)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Supriya Mohile
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Experienced Any Grade 3-5 Toxicity |
0.51; 0.71 | 0.0001 sig |
| SECONDARY Patient Survival at 6 Months |
0.71; 0.74 | 0.39 |
| SECONDARY Reduced Dose Intensity |
0.49; 0.35 | 0.015 sig |
| SECONDARY GA-driven Recommendations Made Among Patients With Impaired Physical Performance. |
74; 35; 45; 62; 38; 92 | — |
| SECONDARY GA-driven Recommendations Made Among Patients With Impaired Functional Status. |
26; 32; 45; 25; 56; 40 | — |
| SECONDARY GA-driven Recommendations Made Among Patients With Impaired Comorbidities. |
201; 45; 28; 45; 113; 10 | — |
| SECONDARY GA-driven Recommendations Made Among Patients With Impaired Cognition. |
88; 10; 43; 22; 6; 12 | — |
| SECONDARY GA-driven Recommendations Made Among Patients With Impaired Nutrition. |
93; 13; 20; 10; 169; 135 | — |
| SECONDARY GA-driven Recommendations Made Among Patients With Impaired Social Support. |
78; 67; 22; 51; 0; 17 | — |
| SECONDARY GA-driven Recommendations Made Among Patients With Impaired Polypharmacy. |
158; 82; 59; 52; 59; 184 | — |
| SECONDARY GA-driven Recommendations Made Among Patients With Impaired Psychological Status. |
44; 20; 42; 18; 11; 24 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02054741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.