Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07175376

Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Levine Cancer Institute, Charlotte, North Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Supportive Care

Other

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

Primary outcomes

  1. Recruitment rate

    Time frame: Enrollment

    The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment

  2. 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

  3. 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.

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

James Morgan

CONTACT

[email protected]

336-702-4491

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Atrium Health Wake Forest Baptist
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.