CancerNCT07175376
Resilience Enhancement Using Electronic Frailty Index-Directed Care Pathway
A study testing Supportive Care in people with Cancer and Frail, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer, Frail, Chemotherapy
- What is being tested?
- Supportive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Mar 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
Kunal Kadakia, MD, 980-442-5905, kunal.kadakia@advocatehealth.org
- Recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
James Morgan, 336-702-4491, james.morgan@advocatehealth.org
Heidi Klepin, MD
About this study
Official title: Resilience Enhancement Utilizing an Electronic Frailty Index-Directed Care Pathway for Older Adults Receiving Chemotherapy (RESILIENCE-e): A Prospective Single-Arm Interventional Study
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.
Read the detailed description
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
- Cancer, Frail, Chemotherapy
- Being tested
- Supportive Care
- Keywords
- Cancer, Frailty Index, eFI score
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareOther
Geriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment
Measured: 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
Measured: 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.
Measured: Weeks 1 to 12
Secondary outcomes (2)
Number of Participants with Hospital admission
Number of participants with hospital admissions during the 12 weeks after chemotherapy initiation
Measured: Baseline to Week 12
Number of Participants with ED visits
Number of participants with Emergency Department (ED) visits during the 12 weeks after chemotherapy initiation
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start16 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Heidi Klepin, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175376
- Sponsor's protocol ID
- IRB00135936
- Other IDs
- P30CA012197, ONC-CCS-2413
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilience Enhancement Utilizing an Electronic Frailty Index-Directed Care Pathway for Older Adults Receiving Chemotherapy (RESILIENCE-e): A Prospective Single-Arm Interventional Study
- ClinicalTrials.gov ID
- NCT07175376
- Acronym / sponsor ID
- IRB00135936
- Conditions
- Cancer, Frail, Chemotherapy
- Keywords
- Cancer, Frailty Index, eFI score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants 65 years or older with active cancer diagnosis and planned chemotherapy | Experimental | Other: Supportive CareParticipants 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive CareGeriatric assessment (GA) -guided supportive care and weekly Patient Reported Outcomes (PRO) symptom assessment | Other | Participants 65 years or older with active cancer diagnosis and planned chemotherapy |
Primary outcome
Recruitment rate
Time frame: Enrollment
The proportion of patients who are enrolled out of the total number of eligible patients approached for enrollment
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
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.
2 secondary outcomes
Number of Participants with Hospital admission
Time frame: Baseline to Week 12
Number of Participants with ED visits
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer
RecruitingPhase 1
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
Solid Tumor
RecruitingPhase 1
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
Lymphoma, Non-Hodgkin's, Lymphoma, Diffuse Large B-Cell
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heidi Klepin, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care in people with Cancer and Frail, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Morgan (336-702-4491, james.morgan@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.