Evaluating geriatric assessments for older adults with lung cancer undergoing treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial assesses the effectiveness of geriatric assessments (GA) combined with GA-directed treatment recommendations in older adults with unresectable non-small cell lung cancer (NSCLC) receiving chemotherapy and radiation therapy. The study aims to identify risk factors for treatment toxicity and functional decline, ultimately improving the quality of life for these patients. By comparing outcomes between those receiving GA-directed interventions and those receiving usual care, the trial seeks to reduce severe non-hematologic toxicities associated with treatment. Additionally, it explores the implementation of GA recommendations and their impact on various health outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ONCOLOGY PHYSICIANS INCLUSION:
* 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
* PATIENTS INCLUSION:
* 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
* Chemotherapy will be defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) will be allowed. Given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies
* Patients who are receiving approved cancer treatment in combination or sequentially with radiation including hypo fractionated radiation (45-60Gy in 15-20 fractions) are eligible
* Those patients with oligometastatic disease having only one site and one lesion outside of the radiation field will be eligible. Examples include a solitary brain metastasis (met), contralateral lung nodule or an adrenal metastatic site
* A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met
* 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)

Exclusion Criteria:

* PATIENTS EXCLUSION:
* 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
* More than one metastatic site: Examples: brain and adrenal, adrenal and liver

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting
• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting
• University of Rochester
  Rochester, New York, United States Not yet recruiting

Study contacts

• Principal investigator: Arya Amini — City of Hope Medical Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.