This clinical trial tests how well a geriatric assessment (GA) with GA-directed treatment recommendations, compared to GA with usual care, works in identifying risk factors, reducing chemotherapy radiation toxicity and functional decline, and improving the overall quality of life in older patients with non-small cell lung cancer (NSCLC). Older patients with lung cancer undergoing chemotherapy are at an increased risk of adverse outcomes including treatment toxicity and functional and physical consequences. This makes it very challenging for the physicians to balance the benefits against the risk of chemotherapy in older cancer patients. A geriatric assessment may be useful in identifying risk factors for chemotherapy radiation toxicity. Communicating these geriatric assessment findings and assessment-based recommendations to a patient's treating physicians may help them make more informed decisions about treatment options for patients. Making treatment decisions using GA-based recommendations may reduce adverse events and improve outcomes in patients receiving treatment for NSCLC.
Oncology physicians must work at the participating site with no plans to leave that site or retire at the time of enrollment into the study
Any patient with unresectable non-small cell lung cancer diagnosis who is 60 years of age or older and must be treated at the participating site
Clinical staging without pathological confirmation of nodal disease is allowed
Plan to start a new cancer treatment regimen within 4-6 weeks from time of baseline study visit. 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. This can be either concurrent or sequential with radiation therapy
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
Participant or healthcare proxy has adequate understanding of the English language (preferred) because not all GA measures have been validated in other languages. Study team should be contacted for any participants with other preferred languages including Spanish and Mandarin. Inclusion of these participants will depend upon the availability of the translators and their ability to accurately translate the measures as approved by the local Institutional Review Board (IRB)
Have surgery planned within 3 months of approach date. Patients who have previously received surgery are eligible
Presence of symptomatic brain metastases (if more than one) at time of study consent process. Patients with history of treated brain metastases or small indeterminate lesions (< 1cm) are eligible if they are not symptomatic at the time of study enrollment
Parallel
Best Practice
Other interventionReceive usual care
Biospecimen Collection
Procedure/SurgeryUndergo blood and stool sample collection
Communication Intervention
Other interventionReceive GA assessment summary and assessment-based recommendations
Comprehensive Geriatric Assessment
Other interventionComplete GA
Electronic Health Record Review
Other interventionAncillary studies
Survey Administration
Other interventionAncillary studies
Incidence of grade 3-5 non-hematologic toxicities
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0) for grade 3-5 non-hematologic toxicities. Chi-square test will be used to compare proportion of patients with grade 3-5 non-hematologic toxicity between two arms at 6 months after treatment initiation.
Overall grade 3 to 5 toxicities
Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v 5.0) for grade 3-5 toxicities. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicities between two arms at 6 months after treatment initiation.
Patient-reported symptomatic toxicities
Will be assessed by the Patient Reported Outcome version of the Common Terminology Criteria for Adverse Events and Patient Reported Outcomes Measurement Information System (PROMIS)-10. Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Function
Will be assessed by activities of daily living/instrumental activities of daily living. T test Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
Physical performance -SPPB
Will be assessed by the short physical performance battery (SPPB) which is scored according to instruction, range from 0 to 12), T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
