Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07175376

Conditions

Cancer

Frail

Chemotherapy

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Supportive Care

Study Details

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.

Conditions

Cancer

Frail

Chemotherapy

Study ID

NCT07175376

Start date

Mar 16, 2026

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

Interventions

Supportive Care

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

Primary outcome measure

  • Recruitment rate [ Time Frame: Enrollment ]
  • Retention rate [ Time Frame: At 12 weeks after initiation of standard of care chemotherapy ]
  • Completion rate of Weekly Symptom Assessment [ Time Frame: Weeks 1 to 12 ]

Central Contacts and Locations

Central contacts

James Morgan

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

Locations

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Kunal Kadakia, MD

980-442-5905kunal.kadakia@advocatehealth.org

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

James Morgan

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

Principal Investigator:

Heidi Klepin, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 2, 2026

Last verified

Jul, 2026

Keywords

  • Cancer
  • Frailty Index
  • eFI score

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-02.