Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer

Study Overview
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Brief Summary
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This randomized clinical trial studies a geriatric assessment intervention in predicting chemotherapy toxicity and vulnerabilities (or weakness) in older patients with cancer. Assessing patients' functional status, comorbidities, psychological state, social support, nutritional status, and cognitive function before treatment may help identify vulnerabilities, improve care, and decrease chemotherapy side effects in older patients with cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To identify areas of vulnerability in older adults with cancer through the use of a geriatric assessment, and to identify the potential referrals to an interdisciplinary team based on geriatric assessment results. II. To determine whether the geriatric assessment driven interventions will lead to decrease in grade 3-5 toxicity. SECONDARY OBJECTIVES: I. To determine whether the geriatric assessment driven interventions will lead to improvement in the following outcomes: unplanned hospitalization, average length of stay (ALOS), emergency visits, unplanned readmission rates, and advance directive completion. II. To determine whether there is significantly better quality of life (QOL) and function in the geriatric assessment intervention group compared to the standard of care group from start of treatment to the follow-up timepoint. III. To determine the feasibility of delivering geriatric assessment driven interventions in a community setting using telemedicine. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients follow an intervention plan created by the nurse practitioner (NP) using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance. ARM II: Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth.

Official Title
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Advancing Screening and Treatment for Older Patients With Cancer

Conditions
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Solid Neoplasm

Intervention / Treatment
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* Other: Comprehensive Geriatric Assessment
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of a solid tumor malignancy (any stage) Scheduled to start a new chemotherapy regimen (any line, combination cytotoxic chemotherapy with targeted agents are allowed) English, Spanish, and/or Chinese speaking Able to provide written informed consent Exclusion Criteria: Not fluent in English, Spanish and/or Chinese (because not all questionnaires have been validated in other languages)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (geriatric assessment-driven treatment)<br>Patients follow an intervention plan created by the NP using the results of the geriatric assessment. The NP discusses the results of the assessment and treatment recommendations with the patient. They also share the treatment plan, proposed referrals, and specific vulnerabilities with the primary care physician and community oncologist. Some patients complete the intervention plan via Telehealth, which uses telecommunication technology to provide health services over a distance. | Other: Comprehensive Geriatric Assessment<br>* Follow geriatric assessment-driven treatment plan<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (standard of care)<br>Patients follow a standard of care treatment plan at the discretion of the primary oncologist. Beginning 6 months from the start of chemotherapy, patients undergo the geriatric assessment as in Arm I. Some patients complete the standard of care treatment plan via Telehealth. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of grade 3-5 toxicity during chemotherapy | Compared pre versus (vs) post-chemotherapy. Tested using general linear models with an alpha of 0.05. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hospitalizations during chemotherapy | Compared pre vs post-chemotherapy. General linear models will be considered for testing, but no alpha adjustments will be applied for multiple comparisons. | Up to 6 months | 
| Change in functional status as measured by the Older American Resources and Services Instrumental Activities of Daily Living | Compared pre vs post-chemotherapy. Explored using multivariate analyses. Results will be stratified by covariates such as patient age, poly- versus mono-chemotherapy, dose reduced or full dose therapy upfront, adjuvant versus metastatic disease, and number of prior chemotherapy regimens. | Baseline to up to 6 months | 
| Change in quality of life as measured by Functional Assessment of Cancer Therapy - General | Compared pre vs post-chemotherapy. Explored using multivariate analyses. Results will be stratified by covariates such as patient age, poly- versus mono-chemotherapy, dose reduced or full dose therapy upfront, adjuvant versus metastatic disease, and number of prior chemotherapy regimens. | Baseline to up to 6 months |