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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

Study 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.Check my eligibility

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.See study design

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of grade 3-5 toxicity during chemotherapy

Secondary outcome measures

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 • NCT02673398

60%

Diarrhea

24%

Lymphocyte count decreased

24%

Death

16%

White blood cell count decreased

16%

Anemia

12%

Abdominal pain

12%

Nausea

12%

Anorexia

12%

Fatigue

Vomiting

Dehydration

Pneumonia

Generalized muscle weakness

Rash maculo-papular

Hypertension

Syncope

Neutrophil count decreased

Platelet count decreased

Hypoalbuminemia

Weight loss

Acute kidney injury

Aspartate aminotransferase increased

Skin laceration

Ejection fraction decreased

Creatinine increased

Pericardial tampo

Appendicitis

T7 mets with spinal cord compression

Dyspnea

Pleural effusion

Respiratory failure

Hypoxemic respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Neratinib)

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.

0 / 2Eligibility criteria met