Enhanced Assistance During Radiotherapy for Cancer

(EARN Trial)

No longer recruiting at 1 trial location

Overseen By Joanna Yang, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Anaplastic thyroid cancer, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if enhanced assistance can help cancer patients complete their radiotherapy without delays. It focuses on individuals undergoing more than 10 radiotherapy sessions who have unmet essential needs, such as food or transportation issues. Participants will receive extra help in addition to the usual support to address these needs. Ideal candidates are those receiving treatment at Barnes-Jewish Hospital and facing challenges that standard assistance cannot fully address. As an unphased trial, this study offers a unique opportunity to receive additional support that could significantly improve the treatment experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this enhanced assistance is safe during radiotherapy?

Research has shown that extra support during radiotherapy is generally safe for patients. In earlier studies, patients who received this support had fewer hospital visits. On average, they experienced 1.72 fewer hospital admissions, and their hospital stays were shorter. This suggests that the treatment is well-tolerated and might even reduce the need for additional medical care. No specific reports of negative effects have been linked to the extra support, reinforcing its safety when used with radiotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Assistance during radiotherapy for cancer because it goes beyond treating the cancer itself and focuses on improving patients' overall well-being. Unlike standard care that primarily targets the tumor, this approach provides additional financial support to address unmet essential needs during treatment. This holistic method aims to reduce stress and improve the quality of life for patients, potentially leading to better treatment outcomes. By addressing financial burdens, researchers hope to discover if enhanced assistance can lead to improved adherence to radiotherapy and overall patient satisfaction.

What evidence suggests that enhanced assistance during radiotherapy is effective for cancer?

Research has shown that extra support during radiotherapy can greatly improve patient health. In this trial, participants will receive standard assistance plus enhanced financial support for unmet essential needs during radiotherapy. Previous studies found that patients who received this extra help had fewer hospital visits and shorter stays. With more support, patients can manage their treatment better and require less additional care. These benefits make it easier for patients to complete their radiotherapy on time. Overall, extra support may lead to better health outcomes for cancer patients undergoing radiotherapy. ^{1 5 6 7 8}

Who Is on the Research Team?

Joanna Yang, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for patients with various cancers, including uterine, salivary gland, head and neck, vaginal, esophageal, stomach, bladder, cervical cancer and more. Participants must be undergoing radiotherapy in over 10 sessions.

Inclusion Criteria

Have unmet essential needs that cannot be fully addressed by standard assistance

Indicate at least 1 unmet essential need such as food insecurity, transportation insecurity, housing instability, utility needs, childcare needs, or other financial insecurity

I am undergoing or scheduled for a specific long-term radiation therapy aimed at curing my condition.

Exclusion Criteria

My radiotherapy simulation is scheduled for more than 28 days after I give consent.

I am in the hospital and will not have more than 10 radiotherapy sessions as an outpatient.

I am currently being treated for anaplastic thyroid cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive radiotherapy with enhanced assistance for unmet essential needs

4 months

Follow-up

Participants are monitored for delay-free completion of radiotherapy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced assistance

Trial Overview

The study tests if enhanced assistance during radiotherapy helps patients complete their treatment without delays compared to past data on standard support.

How Is the Trial Designed?

Group I: Standard Assistance + Enhanced Assistance Experimental Treatment 2 Interventions

In the time period that patients are receiving radiotherapy, study participants will receive standard plus enhanced financial assistance for unmet essential needs.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

American Society of Clinical Oncology

Collaborator

Trials

40

Recruited

148,000+

Published Research Related to This Trial

A comprehensive review of over 7,700 radiotherapy incidents from 1976 to 2007 revealed that 3,125 cases resulted in patient harm, including serious outcomes like overdose toxicity and even death in 1% of cases.

The World Health Organization has published a radiotherapy risk profile emphasizing the importance of communication, training, and adherence to protocols to enhance patient safety in radiotherapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An international review of patient safety measures in radiotherapy practice. Shafiq, J., Barton, M., Noble, D., et al.[2022]

Emotional support is crucial for patients undergoing radiation therapy, and a written interview can help radiation oncologists provide realistic information and support throughout the treatment process.

Supportive care measures also focus on protecting and maintaining the health of body tissues affected by radiation and chemotherapy, including skin and mucosal tissues, while addressing nutritional needs to combat weight loss during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive therapy in radiation oncology. Rotman, M., Rogow, L., DeLeon, G., et al.[2019]

In a study of 322,887 cancer patients undergoing treatment, 19% experienced oncology-specific adverse events, with higher rates in those with metastatic cancers (41% for colorectal and 50% for lung cancer).

The most common triggers for these adverse events included abnormal serum bicarbonate levels and blood transfusions, highlighting the need for targeted monitoring in cancer care to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. Weingart, SN., Nelson, J., Koethe, B., et al.[2021]

Over a 27-month study involving four clinical physicists, 871 safety events were recorded during radiation therapy quality assurance, with 4.7% classified as high severity, highlighting the importance of incident learning in improving safety protocols.

The study identified that targeted interventions, such as preplanning chart rounds and increased automation in planning processes, could effectively reduce the occurrence of high-risk errors in radiation therapy clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fusion of Incident Learning and Failure Mode and Effects Analysis for Data-Driven Patient Safety Improvements. Paradis, KC., Naheedy, KW., Matuszak, MM., et al.[2021]

In a study involving 22 family members and friends of cancer patients undergoing radiotherapy, participants identified themselves as 'helpers' rather than 'carers', highlighting their supportive role during treatment.

The research revealed two types of help: invisible support that helpers provided without the patient's knowledge and visible support that was openly discussed, emphasizing the importance of recognizing and supporting the role of helpers in the cancer care process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The construction of help during radiotherapy: Redefining informal care. Appleton, L., Perkins, E.[2018]

Supportive care in cancer, as defined by the MASCC, plays a crucial role in managing the physical and psychological effects of cancer and its treatments, aiming to enhance quality of life throughout the entire cancer journey.

Evidence suggests that supportive care not only improves patient morbidity and quality of life but also has potential health economic benefits, highlighting its importance in cancer treatment and survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive Care: The "Keystone" of Modern Oncology Practice. Scotté, F., Taylor, A., Davies, A.[2023]

Patients nearing discharge after primary curative treatment for cancer expressed a need for both personal and social support, emphasizing the importance of trust-based relationships with healthcare providers to help them regain a sense of control.

Tailored support that adapts to patients' changing needs can significantly enhance their feelings of safety and well-being, suggesting that healthcare professionals should focus on providing personalized care beyond just biomedical information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Need of support perceived by patients primarily curatively treated for breast, colorectal, or prostate cancer and close to discharge from hospital-A qualitative study. Hajdarevic, S., Fallbjörk, U., Fransson, P., et al.[2022]

The Enhanced Supportive Care (ESC) service, implemented for 265 patients with treatable but not curable cancer, required a multidisciplinary team and cost £125,542 over 12 months.

Patients receiving ESC had significantly reduced secondary care usage, with 1.72 fewer hospital admissions and shorter average lengths of stay, leading to a total savings of £2,398,537.68 in healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary supportive care in cancer: cost analysis. Monnery, D., Liu, Y., Griffiths, A., et al.[2022]

Concurrent chemotherapy and radiotherapy (CCRT) followed by durvalumab immune therapy is the standard treatment for fit stage III non-small-cell lung cancer (NSCLC), but it can cause significant toxicity and side effects, making supportive care essential.

Experts recommend various supportive care strategies, including smoking cessation, nutrition management, physical exercise, and specific treatments for side effects like esophagitis and fatigue, to improve patient quality of life and outcomes during CCRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendation for supportive care in patients receiving concurrent chemotherapy and radiotherapy for lung cancer. De Ruysscher, D., Faivre-Finn, C., Nackaerts, K., et al.[2021]

An automated trigger tool designed for radiation oncology was developed and validated, analyzing 3159 treatment courses over 3.5 years, and successfully identified additional near-miss events that were not reported through voluntary reporting systems.

The tool showed a modest predictive performance with an area under the curve of 0.652, indicating it can help detect potential high-grade near misses, suggesting that further exploration and refinement of such tools could enhance patient safety in radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Radiation Oncology-Specific Automated Trigger Indicator Tool for High-Risk, Near-Miss Safety Events. Hartvigson, PE., Gensheimer, MF., Spady, PK., et al.[2020]

Patients undergoing radiotherapy often experience distress due to a lack of relevant information, feelings of isolation, and inadequate support from family and caregivers, highlighting the need for improved patient care policies.

A multidisciplinary approach involving training for caregivers, collaboration with psychologists and social workers, and emotional support from healthcare professionals is essential to enhance the patient experience during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The patient care experience in radiotherapy: perspectives for better patient support]. Dilhuydy, JM., Hoarau, H., Délices, BF., et al.[2019]

A comprehensive electronic condition reporting program in a multisite radiation oncology department led to the reporting of 8,504 conditions over 46 months, averaging 185 reports per month, which indicates strong employee engagement and a proactive approach to safety.

The majority (98%) of reported conditions were classified as low severity, allowing the department to address potential issues before they escalated into serious adverse events, thus enhancing overall patient safety and quality improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incident learning in pursuit of high reliability: implementing a comprehensive, low-threshold reporting program in a large, multisite radiation oncology department. Gabriel, PE., Volz, E., Bergendahl, HW., et al.[2019]

Recent meta-analyses indicate that combination chemotherapy provides a modest survival benefit compared to best supportive care, challenging the belief that chemotherapy offers no advantages.

Chemotherapy has been associated with improvements in performance status and specific disease-related symptoms, such as pain and dyspnoea, suggesting that more patients experience benefits than what is reflected by objective response rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptomatic benefit from gemcitabine and other chemotherapy in advanced non-small cell lung cancer: changes in performance status and tumour-related symptoms. Thatcher, N., Anderson, H., Betticher, DC., et al.[2022]

About 13% of cancer patients undergoing outpatient radiotherapy expressed a desire for psychooncology (PO) support, with low emotional wellbeing and lack of social support being strong predictors of this wish.

The study highlights that psychosocial issues are more indicative of the need for PO support than demographic or clinical factors, suggesting that routine stress screening should be integrated into cancer care to better identify patients in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer patients' wish for psychological support during outpatient radiation therapy : Findings from a psychooncological monitoring program in clinical routine. Riedl, D., Gastl, R., Gamper, E., et al.[2019]

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