Enhanced Assistance During Radiotherapy for Cancer

(EARN Trial)

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

33 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Enhanced Assistance During Radiotherapy for Cancer?

Research shows that enhanced supportive care, which includes a multiprofessional approach, is being developed to support cancer patients, suggesting potential benefits in managing symptoms and improving quality of life during radiotherapy. Additionally, psychooncology can help patients cope with stress during outpatient radiotherapy, indicating that supportive care can be beneficial. ^{1 2 3 4 5}

Is Enhanced Assistance During Radiotherapy safe for humans?

The safety of radiotherapy, including supportive care during treatment, has been studied extensively. While errors and adverse events can occur, many safety measures and tools are in place to minimize risks, such as incident learning programs and trigger tools to detect potential issues. Communication, training, and adherence to guidelines are crucial for improving safety. ^{6 7 8 9 10}

How is the Enhanced Assistance During Radiotherapy treatment different from other cancer treatments?

Enhanced Assistance During Radiotherapy is unique because it focuses on providing emotional and nutritional support, managing side effects, and improving quality of life during cancer treatment, rather than directly targeting the cancer itself. This supportive care approach helps patients cope with the physical and psychological challenges of radiotherapy. ^{5 11 12 13 14}

What is the purpose of this trial?

This is a prospective single-arm study of an enhanced assistance intervention for patients with unmet essential needs undergoing \>10 fractions of radiotherapy comparing delay-free completion of radiotherapy in study participants to historic controls.

Research Team

Joanna Yang, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary supportive care in cancer: cost analysis. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Cancer patients' wish for psychological support during outpatient radiation therapy : Findings from a psychooncological monitoring program in clinical routine. [2019]

4. France pubmed.ncbi.nlm.nih.gov

[The patient care experience in radiotherapy: perspectives for better patient support]. [2019]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A Radiation Oncology-Specific Automated Trigger Indicator Tool for High-Risk, Near-Miss Safety Events. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The Fusion of Incident Learning and Failure Mode and Effects Analysis for Data-Driven Patient Safety Improvements. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. [2021]

9. Netherlands 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. [2019]

10. Ireland pubmed.ncbi.nlm.nih.gov

An international review of patient safety measures in radiotherapy practice. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The construction of help during radiotherapy: Redefining informal care. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Supportive therapy in radiation oncology. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Recommendation for supportive care in patients receiving concurrent chemotherapy and radiotherapy for lung cancer. [2021]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Supportive Care: The "Keystone" of Modern Oncology Practice. [2023]