Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Best Practice
  • Biospecimen Collection
  • Communication Intervention
  • Comprehensive Geriatric Assessment
  • Electronic Health Record Review
  • Survey Administration

Treatment groups

180 Participants
are divided into 2 treatment groups

Locations

3
City of Hope Medical Center91010, DuarteCalifornia, United States
University of Rochester14642, RochesterNew York, United States
Ohio State University Comprehensive Cancer Center43210, ColumbusOhio, United States

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator