Modernized Instructions for Cancer

(PEERs Trial)

Overseen By Priya Gurjar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Prior radiotherapy, Inpatient, Prisoners, others

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

Compensation: Varies

Number of Visits: Unknown

650 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 Modernized patient instructions treatment for cancer?

Research shows that when patients understand health information clearly, they tend to have better health outcomes, such as improved control of conditions and fewer hospitalizations. Simplifying medical instructions and using plain language can help patients follow their treatment plans more effectively, which may support the effectiveness of Modernized patient instructions in cancer care. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Safety data from various studies show that adverse events (unwanted side effects) are common in cancer treatments, with 83% of patients in one study reporting them. Proper education and adherence to safety practices can reduce risks, highlighting the importance of understanding potential side effects and following medical guidance. ^{6 7 8 9 10}

How does the Modernized Instructions for Cancer treatment differ from other cancer treatments?

The Modernized Instructions for Cancer treatment is unique because it focuses on providing clear, patient-friendly guidelines that help patients understand their treatment options and the potential benefits and risks, which is different from traditional treatments that may not prioritize patient education and comprehension. ^{1 11 12 13 14}

What is the purpose of this trial?

Daily patient participation is critical to the successful, life-saving delivery of radiotherapy. There is very little in the literature describing the best way to prepare patients to give optimal participation. This study aims to look at an already-prepared conversion of patient instruction materials and measure whether the improvement in clarity and specificity produces the desired changes in patient decision-making and emotional comfort.

Research Team

Kathryn Hitchcock, MD, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for adults (18+) who are about to start their first external beam radiotherapy for cancer. Participants must be able to give written consent and agree to follow the study procedures.

Inclusion Criteria

I am 18 or older and planning my first radiation treatment.

I have signed the consent form and agree to follow the study's procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive radiotherapy with either modernized or existing patient instructions

8 weeks

Daily visits for radiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after radiotherapy

4 weeks

Treatment Details

Interventions

• Modernized patient instructions

Trial Overview The study compares existing patient instructions with modernized versions to see if clearer, more specific guidelines improve patients' decision-making and emotional comfort during radiotherapy.

Participant Groups

Group I: Arm 2: Modernized patient instructions Experimental Treatment 1 Intervention

Group II: Arm 1: Existing patient instructions Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

Patient versions of oncology guidelines in Germany effectively translate complex medical recommendations into plain language, making them accessible to educated laypeople, as confirmed by automated readability analyses and positive user feedback.

While these guidelines meet the needs of their target audience, there is a recognized need for additional formats that cater to individuals with lower health literacy, although it's uncertain if these simpler formats can adequately convey the complexities of high-quality clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient guidelines in oncology: objectives, procedures and first experiences with this format]. Schaefer, C., Zowalla, R., Wiesner, M., et al.[2015]

A randomized controlled trial with 84 mental health service users showed that rewriting clinical guidelines in behaviorally specified 'plain English' significantly increased participants' intentions to implement the guidelines and their positive attitudes towards them.

The study found no difference in satisfaction or perceived comprehension between the original and rewritten guidelines, suggesting that the improved clarity and specificity may enhance implementation without compromising understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Words matter: increasing the implementation of clinical guidelines. Michie, S., Lester, K.[2018]

Patients with low literacy skills, which affects about 90 million adult Americans, often struggle to understand their health information, leading to poor compliance with treatment plans.

To improve patient understanding and compliance, healthcare providers should use simpler language, repeat instructions, provide easy-to-read educational materials, and involve family members in the education process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient education for patients with low literacy skills. Mayeaux, EJ., Murphy, PW., Arnold, C., et al.[2007]

Understanding health care information, such as medication directions and physician guidance, leads to improved health outcomes for consumers.

Lack of comprehension of medical instructions can result in serious health issues, including poor management of chronic conditions like diabetes, increased hospitalizations, and medication errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crystal-clear communication. Kantor, A.[2008]

Non-compliance in patients is often due to a lack of information and support from healthcare providers rather than intentional neglect, highlighting the need for better communication and education.

Effective self-management programs, particularly for conditions like type 1 diabetes and severe asthma, can significantly improve treatment outcomes when they provide evidence-based knowledge and empower patients, unlike generic programs that do not target specific diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Does patient knowledge improve treatment outcome?]. Mühlhauser, I., Lenz, M.[2019]

In a study of 101 adult cancer patients undergoing chemotherapy, 83% reported experiencing adverse events, highlighting the common side effects of anticancer drugs.

The research found that 11% of adverse events and a significant portion of medical consultations and hospitalizations were linked to a lack of therapeutic education, emphasizing the need for better patient education on treatment and supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. Santucci, R., Aatmani, AE., Lescoute, A., et al.[2017]

A review of 209 lung cancer phase I and II trials presented at the American Society for Clinical Oncology meetings from 2017 to 2019 revealed significant variability in how adverse events (AEs) were reported, with six different thresholds for reporting AEs of any grade.

Treatment-related AEs were reported twice as often as treatment-emergent AEs, and there was a lack of clear definitions for critical terms like dose-limiting toxicity and serious AEs, highlighting the need for standardized reporting methods to improve data comparability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. Simons, EA., Smith, DE., Gao, D., et al.[2021]

In the ICON8 ovarian cancer clinical trial, 51,019 adverse events were reported, but only 61% of serious adverse events were matched to existing adverse events, indicating a significant gap in safety reporting.

Re-analyzing safety data by including serious adverse events increased the detection of grade 3 or worse safety events, highlighting the importance of comprehensive safety data collection for accurate risk assessment in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. James, EC., Dunn, D., Cook, AD., et al.[2021]

A review of 325 phase III oncology randomized clinical trials (RCTs) from 2007 to 2011 revealed a mean adverse event reporting quality score (AERQS) of only 10.1 out of 16, indicating significant shortcomings in how adverse events (AEs) were reported.

Key areas of poor reporting included the methodology for AE collection (only 10% adequately reported), descriptions of AEs leading to withdrawals (15%), and attribution of AEs to trial interventions (38%), highlighting the need for better adherence to the 2004 CONSORT guidelines for improved transparency in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review. Péron, J., Maillet, D., Gan, HK., et al.[2022]

The implementation of Medical Safety Practice (MSP) significantly reduced medication errors in childhood leukemia patients, with adherence to chemotherapy processes improving in transcribing, administering, and monitoring after training.

Adverse Drug Events (ADEs) related to chemotherapy also decreased significantly from 52.1% to 30.5% post-intervention, highlighting the effectiveness of MSP in enhancing patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Medication Safety Practice in Childhood Acute Lymphoblastic Leukemia Treatment Mulatsih, S., Dwiprahasto, I., Sutaryo, .[2018]

The study highlights the shift from traditional paternalistic patient education to a more informed approach, emphasizing the importance of educating cancer patients about their treatment options, particularly for those with gynaecological cancers treated with brachytherapy.

It suggests that transitioning from face-to-face education to distance learning can be effective if adult learning principles are applied and communication channels are maintained, ensuring patients receive the support they need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education at a distance. Mitchell, F.[2021]

A standardized computer format for providing essential oncological information has been developed to assist rural hospitals in administering chemotherapy safely and effectively, addressing the limited experience of local health professionals with antineoplastic agents.

This initiative has led to increased satisfaction among participating hospitals, resulting in fewer inquiries and complications related to chemotherapy administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing medication errors in cancer chemotherapy referred to rural and remote hospitals. Gilbar, PJ.[2019]

A cancer patient symposium significantly improved participants' understanding of their disease and treatment options, with knowledge about disease comprehension increasing from 80% to 92% after the event, and treatment options from 60% to 76%.

Despite the improvements, many patients still expressed a desire for more information on various topics, including nutrition and stress management, indicating ongoing knowledge needs even three months after the symposium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living with Cancer: an Educational Intervention in Cancer Patients Can Improve Patient-Reported Knowledge Deficit. Padrnos, L., Bennett, R., Kosiorek, H., et al.[2023]

A new guideline document was developed to help create summarized patient information forms (SPIFs) for cancer clinical trials, which was positively received by over 73% of survey respondents who believed it would aid patient decision-making.

The sample SPIFs created using the guideline were found to be understandable, with reading ease scores indicating they are suitable for patients, thus enhancing the clarity of information provided to those considering participation in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of a guideline document to provide essential information for patient decision making regarding cancer clinical trials. Kao, CY., Aranda, S., Krishnasamy, M., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[Patient guidelines in oncology: objectives, procedures and first experiences with this format]. [2015]

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

Words matter: increasing the implementation of clinical guidelines. [2018]

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

Improving patient education for patients with low literacy skills. [2007]

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

Crystal-clear communication. [2008]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Does patient knowledge improve treatment outcome?]. [2019]

6. France pubmed.ncbi.nlm.nih.gov

[Potential clinical impact of therapeutic education in patients treated with anticancer drugs]. [2017]

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

Variation in Toxicity Reporting Methods for Early Phase Lung Cancer Treatment Trials at Oncology Conferences. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial. [2021]

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

Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review. [2022]

10. Thailand pubmed.ncbi.nlm.nih.gov

Implementation of Medication Safety Practice in Childhood Acute Lymphoblastic Leukemia Treatment [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Patient education at a distance. [2021]

12. Australia pubmed.ncbi.nlm.nih.gov

Preventing medication errors in cancer chemotherapy referred to rural and remote hospitals. [2019]

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

Living with Cancer: an Educational Intervention in Cancer Patients Can Improve Patient-Reported Knowledge Deficit. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Development and testing of a guideline document to provide essential information for patient decision making regarding cancer clinical trials. [2021]