Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway

Official title

Resilience Enhancement Utilizing an Electronic Frailty Index-Directed Care Pathway for Older Adults Receiving Chemotherapy (RESILIENCE-e): A Prospective Single-Arm Interventional Study

Overview

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

• Other Supportive Care
  Geriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment

Primary outcome measures

• Recruitment rate [Time frame: Enrollment]
• Retention rate [Time frame: At 12 weeks after initiation of standard of care chemotherapy]
• Completion rate of Weekly Symptom Assessment [Time frame: Weeks 1 to 12]

Secondary outcome measures (2)

• Number of Participants with Hospital admission [Time frame: Baseline to Week 12]
• Number of Participants with ED visits [Time frame: Baseline to Week 12]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Levine Cancer Institute — Charlotte
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Identifiers

NCT: NCT07175376 · IRB00135936 · P30CA012197 · ONC-CCS-2413

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗