Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway

Purpose

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.

Conditions

  • Cancer
  • Frail
  • Chemotherapy

Eligibility

Eligible Ages
Over 65 Years
Eligible Sex
All
Accepts 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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Participants 65 years or older with active cancer diagnosis and planned chemotherapy
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
  • Other: Supportive Care
    Geriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment

Recruiting Locations

Levine Cancer Institute
Charlotte, North Carolina 28204
Contact:
Kunal Kadakia, MD
980-442-5905
kunal.kadakia@advocatehealth.org

Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157
Contact:
James Morgan
336-702-4491
james.morgan@advocatehealth.org

More Details

Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

James Morgan
336-702-4491
james.morgan@advocatehealth.org

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.