Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway

July 1, 2026 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Heidi Klepin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Enrollment
The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment
Enrollment
Retention rate
Time Frame: At 12 weeks after initiation of standard of care chemotherapy
The proportion of enrolled patient participants who complete Visit 2 out of the total number of patient participants who were enrolled and initiate chemotherapy
At 12 weeks after initiation of standard of care chemotherapy
Completion rate of Weekly Symptom Assessment
Time Frame: Weeks 1 to 12
The total number of weekly assessments completed out of the total number of weekly assessments among participants who enroll and initiate chemotherapy.
Weeks 1 to 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Hospital admission
Time Frame: Baseline to Week 12
Number of participants with hospital admissions during the 12 weeks after chemotherapy initiation
Baseline to Week 12
Number of Participants with ED visits
Time Frame: Baseline to Week 12
Number of participants with Emergency Department (ED) visits during the 12 weeks after chemotherapy initiation
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)
Atrium Health Wake Forest Baptist

Investigators

  • Principal Investigator: Heidi Klepin, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

September 15, 2025

First Posted (Actual)

September 16, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00135936
  • P30CA012197 (U.S. NIH Grant/Contract)
  • ONC-CCS-2413 (Other Identifier: Atrium Health Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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