Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway
NCT ID: NCT07175376
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
32 participants
INTERVENTIONAL
2026-05-31
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Palliative and Oncology Care Intervention: Symptom COACH
NCT03760471
Telehealth Intervention for Improving Distress and Financial Toxicity in the Caregivers
NCT06709404
Stress Management and Resilience Training (SMART) Intervention for Family Caregivers of Individuals With Advanced Cancer
NCT03565757
Adaptive Symptom Self-Management Immunotherapy Study
NCT05715255
Healing Touch or Guided Imagery In Treating Pain, Fatigue, Nausea, and Anxiety in Patients Undergoing Chemotherapy
NCT01553578
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Supportive Care
Geriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Supportive Care
Geriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Atrium Health Wake Forest Baptist
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heidi Klepin, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Levine Cancer Institute
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ONC-CCS-2413
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00135936
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.