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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether new, clearer instructions for cancer patients can enhance their involvement and comfort during radiotherapy, a treatment using high-energy rays to kill cancer cells. The study compares current instructions with updated versions to determine which better informs and prepares patients. It is ideal for adults about to begin their first round of external beam radiotherapy. Participants must be ready to follow the study's procedures and provide written consent. As an unphased trial, this study allows patients to contribute to improving communication and support in cancer care.

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 these modernized patient instructions are safe?

Research has shown that updated patient instructions are safe for use. These instructions help patients understand and follow their cancer treatment plans more effectively. No reports have linked negative effects or side effects directly to these new instructions. The goal is to make the treatment process clearer and more comfortable for patients, especially those receiving radiotherapy, where understanding and involvement are crucial. While many cancer treatments can have side effects, the instructions themselves are not expected to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how modernized patient instructions can enhance cancer treatment outcomes. Unlike traditional patient instructions, which might be complex or outdated, these modernized instructions aim to be more user-friendly and tailored to patients' needs. By potentially improving patients' understanding and adherence to their treatment plans, these new instructions could lead to better management of cancer and improved overall patient experiences. The trial seeks to find out if these modernized instructions can make a meaningful impact on patient outcomes compared to existing methods.

What evidence suggests that modernized patient instructions are effective for improving patient participation in radiotherapy?

Research has shown that when patients clearly understand health information, they often experience better health. For instance, those who receive clear instructions tend to manage their conditions better and enjoy a higher quality of life. In this trial, participants will be divided into two groups: one receiving existing patient instructions and the other receiving modernized patient instructions. Studies have found that updated patient instructions can help people make better decisions and feel more at ease. In cancer care, new methods for patients to report their outcomes have been linked to longer survival and better overall life quality. These findings suggest that modernized patient instructions could increase participation and effectiveness in cancer treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Kathryn Hitchcock, MD, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822297

Patient-Reported Outcome Measures in Cancer Care The findings of this study suggest that the integration of PROMs into cancer care may improve overall survival and quality of life.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12391282/

Effectiveness of question prompt list interventions for patients ... This study aimed to evaluate the effectiveness of question prompt list (QPL) interventions in patients with cancer and to synthesize the ...

3. withpower.com withpower.com/trial/phase-malignancies-2-2024-920f8

Modernized Instructions for Cancer (PEERs Trial) Research shows that when patients understand health information clearly, they tend to have better health outcomes, such as improved control of conditions and ...

4. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/modernizing-patient-reported-outcomes-legacy-measures-contemporary-healthcare

Modernizing Patient-Reported Outcomes: Bridging the Gap ... Using such outdated measures can lead to skewed data that do not capture the true impact of the disease or treatment, overlooking the evolving ...

5. nature.com nature.com/articles/s41746-025-01812-x

Effectiveness of symptom monitoring on electronic patient ... The meta-analysis showed significant improvement in health-related quality of life (SMD = 2.44, P < 0.001) among patients with lung cancer.

6. fda.gov fda.gov/media/149994/download

Core Patient-Reported Outcomes in Cancer Clinical Trials Cancer trials typically employ standardized efficacy assessments using overall survival and tumor measures, and safety assessments provided by clinician ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3119205/

Improving Modern Cancer Care Through Information ... This article presents a review of the challenges of delivering well coordinated, patient-centered cancer care in a complex modern healthcare system.

8. prescancerpanel.cancer.gov prescancerpanel.cancer.gov/reports-meetings/enhancing-patient-navigation-2024/action-to-improve-equity/privacy-security-data-sharing

Priority 4: Maintain Privacy and Security While Facilitating ... The cancer journey creates vast quantities of patient health data, including test results, referrals, prescriptions, visit summaries, ...

9. researchgate.net researchgate.net/publication/51451269_Safety_hazards_in_cancer_care_Findings_using_three_different_methods

(PDF) Safety hazards in cancer care: Findings using three ... Adverse events in cancer care were identified through reports from healthcare staff to the Danish Patient Safety Database, a retrospective chart ...