Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-16 @ 11:40 PM
Study NCT ID:
NCT02517034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2015-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Geriatric Assessment in Predicting Chemotherapy Toxicity and Vulnerabilities in Older Patients With Cancer
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
Advancing Screening and Treatment for Older Patients With Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: