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Geriatric Assessment for Cancer
N/A
Waitlist Available
Led By Daneng Li
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of a solid tumor malignancy (any stage)
Scheduled to start a new chemotherapy regimen (any line, combination cytotoxic chemotherapy with targeted agents are allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial assesses whether a geriatric assessment can help identify vulnerabilities in older patients with cancer that may improve care and decrease chemotherapy side effects.
Who is the study for?
This trial is for older adults with any stage of solid tumor cancer who are about to start a new chemotherapy regimen. Participants must speak English, Spanish, or Chinese and be able to give written consent. It's not open to those who aren't fluent in these languages.
What is being tested?
The study tests if assessing an older patient's overall health before chemotherapy can predict treatment side effects and identify vulnerabilities. Patients will complete questionnaires and undergo comprehensive assessments covering function, comorbidities, psychology, social support, nutrition, and cognition.
What are the potential side effects?
Since this trial focuses on assessment rather than medication or invasive procedures, direct side effects from interventions are minimal. However, the study aims to reduce potential chemotherapy-related side effects by tailoring treatment plans based on the geriatric assessment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a solid tumor cancer.
Select...
I am about to start a new chemotherapy treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of grade 3-5 toxicity during chemotherapy
Secondary study objectives
Change in functional status as measured by the Older American Resources and Services Instrumental Activities of Daily Living
Change in quality of life as measured by Functional Assessment of Cancer Therapy - General
Rate of hospitalizations during chemotherapy
Side effects data
From 2022 Phase 2 trial • 25 Patients • NCT0267339860%
Diarrhea
24%
Lymphocyte count decreased
24%
Death
16%
White blood cell count decreased
16%
Anemia
12%
Abdominal pain
12%
Anorexia
12%
Fatigue
12%
Nausea
8%
Vomiting
8%
Dehydration
4%
Pneumonia
4%
Rash maculo-papular
4%
Syncope
4%
Neutrophil count decreased
4%
Hypertension
4%
Platelet count decreased
4%
Generalized muscle weakness
4%
Hypoalbuminemia
4%
Weight loss
4%
Acute kidney injury
4%
Aspartate aminotransferase increased
4%
Skin laceration
4%
Ejection fraction decreased
4%
Creatinine increased
4%
Pericardial tampo
4%
Appendicitis
4%
T7 mets with spinal cord compression
4%
Dyspnea
4%
Pleural effusion
4%
Respiratory failure
4%
Hypoxemic respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Neratinib)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (geriatric assessment-driven treatment)Experimental Treatment4 Interventions
Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance.
Group II: Arm II (standard of care)Active Control3 Interventions
Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,922,847 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,022,570 Total Patients Enrolled
3 Trials studying Tumors
925 Patients Enrolled for Tumors
Daneng LiPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fluent in English, Spanish, or Chinese.I speak English, Spanish, or Chinese.I am about to start a new chemotherapy treatment.I have been diagnosed with a solid tumor cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (geriatric assessment-driven treatment)
- Group 2: Arm II (standard of care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.