Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Supportive Care
Other interventionGeriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Participants 65 years or older with active cancer diagnosis and planned chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment
Time frame
Enrollment2
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
Time frame
At 12 weeks after initiation of standard of care chemotherapy3
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.
Time frame
Weeks 1 to 12Secondary outcomes
1
Number of Participants with Hospital admission
Number of participants with hospital admissions during the 12 weeks after chemotherapy initiation
Time frame
Baseline to Week 122
Number of Participants with ED visits
Number of participants with Emergency Department (ED) visits during the 12 weeks after chemotherapy initiation
Time frame
Baseline to Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Wake Forest University Health Sciences
Lead sponsor
Atrium Health Wake Forest Baptist
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov