RecruitingInterventional

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

NCT ID: NCT07175376Sponsor: Wake Forest University Health SciencesLast updated: 2026-05-26

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.

Arms & interventions

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

Outcome measures

Primary

Recruitment rate
The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment
Time frame: Enrollment
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 chemotherapy
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 12

Secondary

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

Sex: AllAge: 65 Years and olderHealthy 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 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

Study locations (2)

Levine Cancer Institute

Charlotte, North Carolina, 28204

Recruiting

Kunal Kadakia, MD · Contact

980-442-5905 kunal.kadakia@advocatehealth.org

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157

Recruiting

James Morgan · Contact

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

Heidi Klepin, MD · Principal Investigator