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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| ONC-CCS-2413 | Other Identifier | Atrium Health Wake Forest Baptist Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| Atrium Health Wake Forest Baptist | OTHER |
| National Cancer Institute (NCI) | NIH |
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The study purpose is to gain a better understanding of the needs of adults aged 65 and older while they are receiving chemotherapy by measuring their resilience and tailor care plans based on their individual needs.
This is a prospective single-arm intervention trial of patients aged 65 or older with an active cancer diagnosis who are planned to receive chemotherapy and are eFI (Electronic Health Record (EHR)-based frailty index) pre-frail or frail.
Patients will be enrolled before initiation of chemotherapy. Following a baseline assessment, subjects will be provided with results regarding their frailty, will be offered referrals for supportive care interventions and will participate in weekly symptom reporting (electronic survey + phone call from research nurse) for 12 weeks. Follow-up assessments will be completed at 12 weeks and a subset of participants and providers in participating clinics will be contacted to consent and participate in an interview to provide feedback on the intervention including barriers/facilitators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants 65 years or older with active cancer diagnosis and planned chemotherapy | Experimental | Participants aged 65 or older with an active cancer diagnosis who are planned to receive chemotherapy and are eFI pre-frail or frail. Participants will be provided with results and education regarding baseline assessments and offered referrals for supportive care interventions to decrease chemotherapy toxicity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportive Care | Other | Geriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment | Enrollment |
| Retention rate | The proportion of enrolled patient participants who complete Visit 2 out of the total number of patient participants who were enrolled and initiate chemotherapy | At 12 weeks after initiation of standard of care chemotherapy |
| Completion rate of Weekly Symptom Assessment | The total number of weekly assessments completed out of the total number of weekly assessments among participants who enroll and initiate chemotherapy. | Weeks 1 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Hospital admission | Number of participants with hospital admissions during the 12 weeks after chemotherapy initiation | Baseline to Week 12 |
| Number of Participants with ED visits |
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Inclusion Criteria:
Patients with cancer:
Providers:
Exclusion Criteria:
Patients:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Morgan | Contact | 336-702-4491 | james.morgan@advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Heidi Klepin, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Number of participants with Emergency Department (ED) visits during the 12 weeks after chemotherapy initiation
| Baseline to Week 12 |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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