Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway

NCT ID: NCT07175376

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-31

Study Completion Date

2027-05-31

Brief Summary

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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

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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.

Conditions

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Cancer Frail Chemotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Supportive Care

Intervention Type OTHER

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

Interventions

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Supportive Care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atrium Health Wake Forest Baptist

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heidi Klepin, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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James Morgan

Role: CONTACT

336-702-4491

Facility Contacts

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Kunal Kadakia, MD

Role: primary

980-442-5905

James Morgan

Role: primary

336-702-4491

Other Identifiers

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ONC-CCS-2413

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00135936

Identifier Type: -

Identifier Source: org_study_id

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