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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-07140 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 23398 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (GA intervention) | Experimental | 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. |
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| Arm II (usual care) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months from treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months from treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arya Amini | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| Biospecimen Collection | Procedure | Undergo blood and stool sample collection |
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| Communication Intervention | Other | Receive GA assessment summary and assessment-based recommendations |
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| Comprehensive Geriatric Assessment | Other | Complete GA |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| 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. | At 6 months from treatment initiation |
| 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. | At 6 months from treatment initiation |
| 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. | At 6 months from treatment initiation |
| Physical performance - 2 minute walking | Will be assessed by 2 minute walking test (meters). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | At 6 months from treatment initiation |
| Physical performance - number of falls | Will be assessed by number of falls (count number). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | At 6 months from treatment initiation |
| Polypharmacy | Will be assessed by the reduction in medication burden. Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | At 3 months from treatment initiation |
| Mood - GDS | Will be assessed by the Geriatric Depression Scale (GDS) 5/15 (scored according to guideline). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | At 6 months from treatment initiation |
| Mood - Anxiety | Will be assessed by PROMIS anxiety (scored according to guideline). T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | At 6 months from treatment initiation |
| Quality of life | Will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scored according to guideline. T test, Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | At 6 months from treatment initiation |
| Treatment completion rates | Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | At 6 months from treatment initiation |
| Hospitalizations/emergency department visit rates | Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | At 6 months from treatment initiation |
| Incidence of adverse events from durvalumab | Chi-square test or fisher's exact test will be used to examine the difference between the two arms. | After completion of adjuvant treatment (12 months) |
| University of Rochester | Not yet recruiting | Rochester | New York | 14642 | United States |
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| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D013048 | Specimen Handling |
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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