Symptom Reporting Tool for Pediatric Cancer

Overseen By Kimberly Pyke-Grimm

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cognitive impairments, Memory impairments, others

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

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new electronic tool designed to help children and young adults with cancer report their symptoms more effectively to doctors. The focus is on simplifying the process for patients and caregivers to share their feelings during outpatient visits, potentially improving communication and care over time. The trial seeks participants who have been recently diagnosed with cancer, are undergoing treatments such as chemotherapy or surgery, and can understand English. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance patient-doctor communication and improve care for future patients.

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 is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this symptom assessment tool is safe for pediatric cancer patients?

Research has shown that using special questionnaires, like the Ped-PRO-CTCAE, is safe for participants. These questionnaires are designed for children, teens, young adults, caregivers, and healthcare providers to gather information on patients' feelings about their symptoms and treatments.

Studies have found that these questionnaires do not cause harm. They collect information directly from patients about their health experiences, such as pain, nausea, and tiredness. This helps doctors understand patients' experiences without requiring medical procedures.

In short, filling out these questionnaires is generally easy and involves no physical health risks. Participants simply share their experiences by answering questions about their symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how symptoms are reported in pediatric cancer patients. Unlike traditional methods that often rely on general assessments, this trial uses age- and role-specific questionnaires, which means that children, adolescents, young adults, caregivers, and clinicians each provide input tailored to their perspective. This personalized approach allows for a more detailed understanding of the patient's condition, potentially leading to better-targeted treatments and care strategies. By incorporating multiple viewpoints, researchers hope to enhance communication and ensure that the unique experiences of young patients are thoroughly understood and addressed.

What evidence suggests that this symptom reporting tool is effective for pediatric cancer?

Research has shown that patient-reported outcome measures (PROMs) are valuable tools for understanding patient experiences and enhancing their quality of life. These questionnaires track symptoms and their impact on daily life, which is crucial for children with cancer. In this trial, participants—including children, adolescents, young adults, caregivers, and clinicians—will complete the Ped-PRO-CTCAE Questionnaire to monitor symptoms. Studies have found that PROMs can enhance communication between patients and doctors, leading to more personalized care. By monitoring symptoms with these tools, doctors can identify problems early, potentially improving treatment outcomes. Overall, PROMs are regarded as a top method for assessing how treatments affect patients' quality of life. ^{1 6 7 8 9}

Who Is on the Research Team?

Kimberly Pyke-Grimm

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This study is for children, adolescents, and young adults with cancer. Participants will use an electronic tool to report symptoms during outpatient clinic visits. Caregivers may also be involved in the process.

Inclusion Criteria

Ability to understand and the willingness to personally sign the written IRB approved informed consent or assent document as appropriate

I am between 7 and 21 years old.

I've completed at least 1 month of chemotherapy and am between treatments or currently in treatment.

Exclusion Criteria

Caregiver must be able to read and understand English

Child must be able to read or listen to and understand English and not have cognitive/memory impairments determined by the child's clinician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Questionnaire Completion

Participants complete study-specific questionnaires at designated time points, including 3 before and 2 after the clinic visit for children/AYAs/caregivers, and 2 after the clinic visit for clinicians.

1 year

Follow-up

Participants are monitored for the feasibility, usability, and acceptability of the Ped-PRO-CTCAE tool in an outpatient oncology clinic setting.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Age- and Role-Specific Questionnaire Administration

Trial Overview

The trial is testing a symptom assessment tool called Ped-PRO-CTCAE designed for young patients with cancer. It's about seeing how feasible and acceptable this electronic questionnaire is when used by patients and shared with their doctors.

How Is the Trial Designed?

Group I: Ped-PRO-CTCAE Questionnaire Completion for Children, AYAs, Caregivers, and Clinicians Experimental Treatment 1 Intervention

Participants in this arm include children, adolescents, young adults (AYAs), caregivers, and clinicians. All participants will complete study-specific questionnaires at designated time points. Child/AYA/Caregiver Group: Participants will complete 3 questionnaires before the clinic visit and 2 questionnaires after the clinic visit. Clinician Group: Clinicians will complete 2 questionnaires after the clinic visit.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a study involving 96 pediatric oncology patients undergoing chemotherapy, most PROMIS pediatric measures showed significant changes over time, indicating their responsiveness and potential effectiveness in capturing patient-reported outcomes during treatment.

The findings support the validity of these measures, demonstrating that they can reliably assess symptoms and psychological impacts in children with cancer, making them suitable for use in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PROMIS pediatric measures validated in a longitudinal study design in pediatric oncology. Hinds, PS., Wang, J., Cheng, YI., et al.[2023]

Feeding back patient-reported outcomes (PROs) to healthcare providers and families of children with advanced cancer did not significantly improve overall symptom distress or health-related quality of life (HRQoL) scores during the 20-week study, based on a multicentered pilot randomized controlled trial involving 104 participants.

However, in a subgroup of children aged 8 years and older who survived the study duration, feedback led to notable improvements in emotional HRQoL and symptom distress, indicating that while the overall impact was limited, there may be specific benefits for certain age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: results from the PediQUEST randomized controlled trial. Wolfe, J., Orellana, L., Cook, EF., et al.[2021]

A study involving 187 pediatric clinicians identified 64 adverse event (AE) terms from the National Cancer Institute's CTCAE that are suitable for self-reporting by children aged 7 and older, enhancing the understanding of treatment toxicities in pediatric cancer.

The goal is to create a child-friendly self-report measure for AEs, which will improve the accuracy and completeness of toxicity reporting in clinical trials, ultimately leading to better care for children undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The first step to integrating the child's voice in adverse event reporting in oncology trials: a content validation study among pediatric oncology clinicians. Reeve, BB., Withycombe, JS., Baker, JN., et al.[2021]

A study involving 17 Brazilian adolescents aged 13-18 undergoing chemotherapy showed that they can effectively describe and report their chemotherapy-related adverse events, highlighting the importance of their perspectives in treatment assessments.

The research indicates that using open-ended questions during interviews can facilitate better communication and understanding of adverse events among adolescent cancer patients, paving the way for improved assessment tools tailored to their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. Silva-Rodrigues, FM., Hinds, PS., Nascimento, LC.[2022]

This study will evaluate the effectiveness of the RESPONSE system, which uses electronic Patient Reported Outcome Measures (PROMs) to provide alerts and recommendations for symptom management in 160 children undergoing cancer treatment, aiming to reduce overall symptom burden.

The trial will also assess the feasibility and acceptability of implementing the RESPONSE system, providing insights into how well it can be integrated into routine care for pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE). Bradford, N., Condon, P., Pitt, E., et al.[2021]

The revised Memorial Symptom Assessment Scale (MSAS) for children aged 7-12 has been shown to be a reliable and valid tool for assessing symptoms in young cancer patients, based on a study involving 149 children undergoing treatment.

About one-third of the children reported experiencing significant symptoms like lethargy, pain, and insomnia, highlighting the importance of systematic symptom assessment in understanding and managing the experiences of young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The measurement of symptoms in young children with cancer: the validation of the Memorial Symptom Assessment Scale in children aged 7-12. Collins, JJ., Devine, TD., Dick, GS., et al.[2022]

A focus group of healthcare professionals found that existing symptom assessment scales for pediatric cancer patients were inadequate due to issues with content validity and complexity, leading to the need for a new tool.

The new Symptom Screening in Pediatrics (SSPedi) Tool was developed, focusing on 15 key symptoms while ensuring it is easy for children to understand and minimizing respondent burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial development of the Symptom Screening in Pediatrics Tool (SSPedi). Tomlinson, D., Dupuis, LL., Gibson, P., et al.[2022]

Out of 236 Individual Case Safety Reports (ICSRs) analyzed, only 18 (7.6%) were classified as off-label cases, indicating a low incidence of off-label use of antineoplastic drugs in pediatric patients, primarily related to therapeutic indications.

Among the off-label cases, 29 adverse drug reactions (ADRs) were reported, with common reactions including diarrhea and neutropenia, suggesting that while off-label use is limited, it can still lead to significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System. Mascolo, A., Scavone, C., Bertini, M., et al.[2022]

A game-based symptom-reporting app was used by 19 school-age children with cancer, showing preliminary feasibility with a median usage of 4 days, and high engagement with features like symptom reporting and drawing.

Both children and parents found the app acceptable, appreciating its interactive nature and the opportunity for children to express their symptoms creatively, suggesting it could enhance autonomy and decision-making in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a game-based symptom-reporting app for children with cancer: perspectives of children and parents. Linder, LA., Newman, AR., Stegenga, K., et al.[2023]

The Ped-PRO-CTCAE [Caregiver] measure has been validated as a reliable tool for caregivers to report symptoms in children undergoing cancer treatment, showing strong correlations with other established measures like the PROMIS Parent Proxy.

This study involved 473 caregivers and demonstrated that the Ped-PRO-CTCAE [Caregiver] effectively distinguishes between different levels of child functioning and responsiveness to treatment changes, highlighting its potential to enhance symptom reporting and improve cancer care for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the caregiver Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events measure. Reeve, BB., McFatrich, M., Lin, L., et al.[2022]

The Ped-PRO-CTCAE measurement system, evaluated in a study with 482 children and adolescents newly diagnosed with cancer, demonstrated strong construct validity and reliability in assessing symptom adverse events during cancer treatment.

The system showed significant correlations with established measures of pain, fatigue, and depression, indicating it can effectively capture the cancer treatment experience and improve symptom reporting in pediatric oncology trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity and Reliability of the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. Reeve, BB., McFatrich, M., Mack, JW., et al.[2021]

The Pediatric Cancer Quality of Life Inventory (PCQL) Modular Approach, which includes a 15-item core measure and symptom modules for pain and nausea, has been validated for use in assessing health-related quality of life (HRQL) in pediatric cancer patients, demonstrating strong internal consistency reliability (0.83 for patient reports and 0.86 for parent reports).

The PCQL effectively distinguishes between patients on and off treatment and correlates with days missed from school, indicating that children can provide reliable and valid responses regarding their HRQL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pediatric Cancer Quality of Life Inventory: a modular approach to measuring health-related quality of life in children with cancer. Seid, M., Varni, JW., Rode, CA., et al.[2019]

The study demonstrated that pediatric cancer patients (ages 8-18) can successfully report symptoms three times a week for eight weeks, achieving a feasibility threshold of 90% adherence in the second cohort of 10 patients.

Interventions such as engaging parents and providing reminders helped improve adherence to symptom reporting, indicating that with the right support, regular symptom monitoring in young patients is achievable and can inform healthcare teams about their needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of three times weekly symptom screening in pediatric cancer patients. Calligan, M., Chakkalackal, L., Dadzie, G., et al.[2023]

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