Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID07175376

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

Led by Wake Forest University Health Sciences · Updated on 2026-05-26

32

Participants Needed

2

Research Sites

17 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

A

Atrium Health Wake Forest Baptist

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying adults aged 65 and older with cancer who are planned to receive chemotherapy and have a pre-frail or frail status based on the Electronic Frailty Index (eFI). The study aims to better understand the needs of these patients by measuring their resilience and tailoring care plans to their individual health status during chemotherapy. This prospective single-arm intervention trial seeks to improve supportive care for this population. Participants will be enrolled before starting chemotherapy and undergo a baseline assessment. They will receive feedback on their frailty status and be offered referrals for supportive care interventions designed to reduce chemotherapy toxicity. Over 12 weeks, participants will complete weekly symptom reports through electronic surveys and phone calls with a research nurse. Follow-up assessments will occur at 12 weeks, and some participants and providers will be invited to interviews to provide feedback on the intervention, including challenges and helpful factors. During the study, participants will be monitored for symptom changes and healthcare use such as hospital admissions and emergency visits. Researchers will track recruitment, retention, and completion rates of symptom assessments. The total participation lasts 12 weeks from chemotherapy initiation, with data collected through surveys, phone calls, medical records, and interviews to better tailor supportive care for older adults undergoing chemotherapy.

CONDITIONS

Brief Title

Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and willingness to sign an IRB-approved informed consent
  • Age 65 years or older at the time of enrollment
  • Planned to start an outpatient chemotherapy regimen for any cancer type or stage
  • Pre-frail or frail status based on the Electronic Frailty Index within 30 days before enrollment
  • Ability to read and understand English
Not Eligible

You will not qualify if you...

  • Physical or psychological conditions limiting ability to understand or follow study procedures
  • Planned chemotherapy at a facility outside the Atrium Health system
  • Currently receiving chemotherapy

AI-Screening

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Your Study Journey

Screening

Duration - Up to 30 days before enrollment

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 12 weeks

Participants receive geriatric assessment-guided supportive care and participate in weekly symptom reporting to help manage chemotherapy side effects.

Weekly symptom reporting via electronic survey and phone call

Follow-up

Duration - At 12 weeks after treatment initiation

Participants complete follow-up assessments and some may participate in interviews to provide feedback on the intervention.

1 follow-up visit and additional interviews for a subset of participants

Trial Site Locations

Total: 2 locations

1

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

2

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

J

James Morgan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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