Supportive Care for Cancer

Not yet recruiting at 1 trial location

Overseen By James Morgan

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Psychological comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to understand how older adults cope with chemotherapy by examining their resilience and personalizing care plans. Researchers will use an Electronic Frailty Index, a tool to measure vulnerability, to guide supportive care through an Electronic Frailty Index-Directed Care Pathway. This approach aims to reduce chemotherapy side effects. The trial suits individuals aged 65 or older with an active cancer diagnosis who are about to start chemotherapy and have been identified as pre-frail or frail. Participants will receive education and referrals for additional support to better manage their treatment. As an unphased trial, this study offers participants the chance to contribute to advancements in personalized care for older adults undergoing chemotherapy.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on patients who are about to start chemotherapy, so it's best to discuss your current medications with the trial team.

What prior data suggests that the Electronic Frailty Index-Directed Care Pathway is safe for older adults receiving chemotherapy?

Research has shown that the Electronic Frailty Index (eFI) aids in understanding how older adults might respond to chemotherapy. This tool predicts the likelihood of experiencing problems from cancer treatments by assessing various health factors, such as existing conditions.

Regarding safety, the eFI is not a treatment. Instead, it customizes care to better fit each person's needs, potentially reducing complications from chemotherapy. This approach is generally well-received because it supports patients rather than directly treating them. No reports indicate that the eFI causes harm. Instead, it helps healthcare providers make informed decisions to improve patient care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electronic Frailty Index-Directed Care Pathway because it offers a personalized approach to managing chemotherapy toxicity in older cancer patients. Unlike standard care options, which might not consider individual frailty levels, this pathway uses a detailed assessment to tailor supportive care. By identifying frail or pre-frail patients, the treatment aims to reduce chemotherapy side effects through targeted interventions, potentially improving both the quality of life and treatment outcomes for this vulnerable group.

What evidence suggests that the Electronic Frailty Index-Directed Care Pathway is effective for supportive care in cancer patients?

Research has shown that the Electronic Frailty Index (eFI) can predict how well older adults might cope with chemotherapy. In this trial, participants aged 65 or older with an active cancer diagnosis and planned chemotherapy will undergo assessment using the eFI. Studies have found that the eFI effectively predicts 30-day survival rates in patients with cancers such as breast and colon cancer. It identifies frailty—weakness or vulnerability due to aging or illness—more accurately than age alone. This allows for more precise customization of care, potentially reducing side effects from cancer treatments. Although more research is needed, early results suggest it could significantly improve care for older cancer patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Heidi Klepin, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 65 and older who are undergoing chemotherapy. It aims to understand their needs better by assessing resilience and creating personalized care plans.

Inclusion Criteria

Providers: Treating medical oncologist of at least one patient participant who enrolled on to the study and completed baseline assessment

Patients with cancer: Ability to understand and willingness to sign an IRB-approved informed consent

Patients with cancer: eFI pre-frail or frail status (available in EHR) within 30 days before enrollment

Exclusion Criteria

Patients: Chemotherapy planned at a facility outside the Atrium Health system

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

I am currently undergoing chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment and receive results regarding their frailty, with referrals for supportive care interventions

1 week

1 visit (in-person)

Chemotherapy and Symptom Reporting

Participants receive chemotherapy and participate in weekly symptom reporting via electronic survey and phone call

12 weeks

12 visits (virtual)

Follow-up

Follow-up assessments are completed, and a subset of participants and providers are interviewed for feedback on the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Frailty Index-Directed Care Pathway

Trial Overview The intervention being studied is a supportive care approach that uses an electronic frailty index to guide the creation of individualized care pathways for elderly patients receiving chemotherapy.

How Is the Trial Designed?

Group I: Participants 65 years or older with active cancer diagnosis and planned chemotherapy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Wake Forest Baptist

Collaborator

Trials

3

Recruited

250+

Atrium Health Wake Forest Baptist

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07175376

Resilience Enhancement Using Electronic Frailty Index ... This is a prospective single-arm intervention trial of patients aged 65 or older with an active cancer diagnosis who are planned to receive ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.12009

Electronic frailty index predicts 30-day mortality from ... The eFI closely predicts poor outcomes from SACT, particularly in early breast and colon cancer, and requires further evaluation in a prospective study.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2260134124004079

Frailty Index, Not Age, Predicts Treatment Outcomes and ... The median FI (IQR) was 0.24 (0.15–0.31) and 43% were frail (FI>0.25). FI was positively correlated with ECOG, however 28% of ECOG 0–1 were frail. In ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10066705/

Frailty and Cancer: Current Perspectives on Assessment ... This review describes the current standards and perspectives for the assessment and monitoring of frailty in elderly patients with cancer.

5. academic.oup.com academic.oup.com/jnci/article/117/7/1316/7991298

Frailty and outcomes in adults undergoing systemic anticancer ... This review and meta-analysis summarizes existing evidence evaluating the association between baseline frailty assessment tools and systemic anticancer ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.28_suppl.375

Electronic Frailty Index: A risk stratification tool for survival ... Electronic frailty index predicts 30-day mortality from chemotherapy in breast, colorectal and lung cancer.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406821000175

Challenges and opportunities to developing a frailty index ... Frailty indices can be developed from varied data sources including elements captured in EHRs, such as comorbidities, laboratory values, and assessments of ...

8. cancernetwork.com cancernetwork.com/view/new-frailty-index-associated-outcomes-older-patients-chemotherapy

New Frailty Index Associated With Outcomes in Older ... That index was found to be associated with outcomes both related to chemotherapy toxicity and to age-related outcomes.