Clinical trial NCT02517034: Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer
Official title: Advancing Screening and Treatment for Older Patients With Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-08-06
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of grade 3-5 toxicity during chemotherapy
timeFrame: Up to 6 months
Secondary outcomes:
measure: Rate of hospitalizations during chemotherapy
timeFrame: Up to 6 months
measure: Change in functional status as measured by the Older American Resources and Services Instrumental Activities of Daily Living
timeFrame: Baseline to up to 6 months
measure: Change in quality of life as measured by Functional Assessment of Cancer Therapy - General
timeFrame: Baseline to up to 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Lancaster
country: United States
facility: City of Hope Antelope Valley
state: California
city: Rancho Cucamonga
country: United States
facility: City of Hope Rancho Cucamonga
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena
state: California
city: West Covina
country: United States
facility: City of Hope West Covina
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Daneng Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li D, Sun CL, Kim H, Soto-Perez-de-Celis E, Chung V, Koczywas M, Fakih M, Chao J, Cabrera Chien L, Charles K, Hughes SFDS, Katheria V, Trent M, Roberts E, Jayani R, Moreno J, Kelly C, Sedrak MS, Dale W. Geriatric Assessment-Driven Intervention (GAIN) on Chemotherapy-Related Toxic Effects in Older Adults With Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Nov 1;7(11):e214158. doi: 10.1001/jamaoncol.2021.4158. Epub 2021 Nov 18.