NCT07175376

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable cancer

Timeline
12mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026May 2027

First Submitted

Initial submission to the registry

September 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

March 16, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 6, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

September 8, 2025

Last Update Submit

April 29, 2026

Conditions

CancerFrailChemotherapy

Keywords

CancerFrailty IndexeFI score

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

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

    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

    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.

    Weeks 1 to 12

Secondary Outcomes (2)

  • Number of Participants with Hospital admission

    Baseline to Week 12

  • Number of Participants with ED visits

    Baseline to Week 12

Study Arms (1)

Participants 65 years or older with active cancer diagnosis and planned chemotherapy

EXPERIMENTAL

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

Interventions

Supportive CareOTHER

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

Participants 65 years or older with active cancer diagnosis and planned chemotherapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Heidi Klepin, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James Morgan

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 16, 2025

Study Start

March 16, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)