Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway

Wake Forest University (WFU)

Status: Begins enrollment in 2 months

Conditions: Chemotherapy; Frail; Cancer

Treatments: Other: Supportive Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07175376

ONC-CCS-2413 (Other Identifier)

IRB00135936

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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 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) 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Participants 65 years or older with active cancer diagnosis and planned chemotherapy

Experimental group

Description:

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

Treatment:

Other: Supportive Care