Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 65 - Any |
Updated: | 9/26/2018 |
Start Date: | August 4, 2015 |
End Date: | June 2019 |
Advancing Screening and Treatment for Older Patients With Cancer
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.
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.
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.
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.
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
We found this trial at
5
sites
Rancho Cucamonga, California 91730
Principal Investigator: Behnam Ebrahimi, MD
Phone: 626-256-4673
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Duarte, California 91010
Principal Investigator: Arti Hurria, MD
Phone: 800-826-4673
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South Pasadena, California 91030
Principal Investigator: Christina Yeon, MD
Phone: 626-256-4673
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West Covina, California 91790
Principal Investigator: Gargi Upadhyaya, MD
Phone: 626-256-4673
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