Advancing Screening and Treatment for Older Patients With Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Questionnaire Administration
- Conditions
- Solid Neoplasm
- Sponsor
- City of Hope Medical Center
- Enrollment
- 600
- Locations
- 10
- Primary Endpoint
- Rate of grade 3-5 toxicity during chemotherapy
- Status
- Active, not recruiting
- Last Updated
- 12 days ago
Overview
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.
Investigators
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)
Arms & Interventions
Arm I (geriatric assessment-driven treatment)
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.
Intervention: Questionnaire Administration
Arm I (geriatric assessment-driven treatment)
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.
Intervention: Comprehensive Geriatric Assessment
Arm I (geriatric assessment-driven treatment)
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.
Intervention: Quality-of-Life Assessment
Arm I (geriatric assessment-driven treatment)
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.
Intervention: Survey Administration
Arm II (standard of care)
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.
Intervention: Quality-of-Life Assessment
Arm II (standard of care)
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.
Intervention: Questionnaire Administration
Arm II (standard of care)
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.
Intervention: Survey Administration
Outcomes
Primary Outcomes
Rate of grade 3-5 toxicity during chemotherapy
Time Frame: Up to 6 months
Compared pre versus (vs) post-chemotherapy. Tested using general linear models with an alpha of 0.05.
Secondary Outcomes
- Rate of hospitalizations during chemotherapy(Up to 6 months)
- Change in functional status as measured by the Older American Resources and Services Instrumental Activities of Daily Living(Baseline to up to 6 months)
- Change in quality of life as measured by Functional Assessment of Cancer Therapy - General(Baseline to up to 6 months)