Cancer, Chemotherapy, Frail
Conditions
Keywords
Cancer, Frailty Index, eFI score
Brief summary
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.
Detailed description
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.
Interventions
OTHERSupportive Care
Geriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment
Sponsors
Wake Forest University Health Sciences
Atrium Health Wake Forest Baptist
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with cancer: * Ability to understand and willingness to sign an IRB-approved informed consent * Age ≥ 65 years at the time of enrollment. * Planned to initiate an outpatient chemotherapy regimen (including myelosuppressive biologic/immune therapies) for cancer treatment (any type or stage), either as an initial therapy or as a new line of therapy, with curative or palliative intent. * eFI pre-frail or frail status (available in EHR; defined as eFI \> 0.10) within 30 days before enrollment. * Ability to read and understand the English language Providers: * Treating medical oncologist of at least one patient participant who enrolled on to the study and completed baseline assessment.
Exclusion criteria
Patients: * Documented physical or psychological comorbidity that would limit participant's ability to understand or comply with study procedures for the entire length of the study per the enrolling investigator. * Chemotherapy planned at a facility outside the Atrium Health system. * Currently receiving chemotherapy (defined as planned to continue an on-going treatment rather than starting a new regimen).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Enrollment | The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment |
| Retention rate | At 12 weeks after initiation of standard of care chemotherapy | The proportion of enrolled patient participants who complete Visit 2 out of the total number of patient participants who were enrolled and initiate chemotherapy |
| Completion rate of Weekly Symptom Assessment | Weeks 1 to 12 | The total number of weekly assessments completed out of the total number of weekly assessments among participants who enroll and initiate chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Hospital admission | Baseline to Week 12 | Number of participants with hospital admissions during the 12 weeks after chemotherapy initiation |
| Number of Participants with ED visits | Baseline to Week 12 | Number of participants with Emergency Department (ED) visits during the 12 weeks after chemotherapy initiation |
Countries
United States
Contacts
CONTACTJames Morgan
PRINCIPAL_INVESTIGATORHeidi Klepin, MD
Wake Forest University Health Sciences
Outcome results
None listed