Trial Title:
Evaluation of Geriatric Assessment and Management for Older Adults With Non-small Cell Lung Cancer Receiving Chemotherapy Radiation Therapy
NCT ID:
NCT06139627
Condition:
Lung Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC v8
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Arm II (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and stool sample collection
Arm group label:
Arm I (GA intervention)
Arm group label:
Arm II (usual care)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Communication Intervention
Description:
Receive GA assessment summary and assessment-based recommendations
Arm group label:
Arm I (GA intervention)
Intervention type:
Other
Intervention name:
Comprehensive Geriatric Assessment
Description:
Complete GA
Arm group label:
Arm I (GA intervention)
Arm group label:
Arm II (usual care)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Arm I (GA intervention)
Arm group label:
Arm II (usual care)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (GA intervention)
Arm group label:
Arm II (usual care)
Summary:
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To demonstrate if providing a GA summary and recommendations for GA-directed
interventions to oncology care teams decreases the proportion of older adults with
unresectable, stage III NSCLC who experience any grade 3-5 non-hematologic toxicity from
chemotherapy and radiation.
SECONDARY OBJECTIVES:
I. To demonstrate the differences between the intervention versus usual care group among:
Ia. Overall grade 3-5 toxicities; Ib. Patient-reported symptomatic toxicities as measured
by Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PROCTCAE),
Patient Reported Outcomes Measurement Information System - 10 (PROMIS-10); Ic.
Implementation of GA recommendations; Id. GA outcomes including function (Activities of
Daily Living/Instrumental Activities of Daily Living,), physical performance (Short
Physical Performance Battery, 2 minute [min] walk, falls), polypharmacy (reduction in
medication burden), mood (Geriatric Depression Scale 5/15 and PROMIS Anxiety short form
4a); Ie. Quality of life (European Organization for Research and Treatment of Cancer
Quality of Life Questionnaire-Core 30 [EORTC-QLQ-30]); If. Treatment sequencing
(concurrent versus sequential) and completion, hospitalizations/emergency department (ED)
rates.
EXPLORATORY OBJECTIVE:
I. To explore microbial diversity and blood components at baseline, and at 6 months from
treatment initiation as a potential biomarker of treatment-related toxicity and disease
response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients complete a geriatric assessment. Patients and physicians receive the
geriatric assessment summary and assessment-based recommendations, which are provided
prior to beginning chemotherapy and radiation, at the midpoint of chemotherapy and
radiation treatment, and at the end of treatment. Patients also undergo blood and stool
sample collection during screening and on study.
ARM II: Patients complete a geriatric assessment, but information other than clinically
significant cognitive impairment and depression is not provided to the oncology teams,
per usual care. Patients also undergo blood and stool sample collection during screening
and on study.
After completion of study intervention, patients are followed up at 4-6 weeks, 10-14
weeks, and 20-26 weeks after baseline.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
60 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Arya Amini
Phone:
626-256-4673
Phone ext:
82247
Email:
Aamini@coh.org
Investigator:
Last name:
Arya Amini
Email:
Principal Investigator
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Supriya G. Mohile
Phone:
585-275-2121
Email:
Supriya_mohile@urmc.rochester.edu
Investigator:
Last name:
Supriya G. Mohile
Email:
Principal Investigator
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carolyn J. Presley
Phone:
614-293-9869
Email:
Carolyn.Presley@osumc.edu
Investigator:
Last name:
Carolyn J. Presley
Email:
Principal Investigator
Start date:
May 21, 2024
Completion date:
July 19, 2026
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139627
