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

Trial Summary

What is the purpose of this trial?

The purpose of this project is to pilot test an electronically delivered symptom assessment tool Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE), completed by children/adolescents and young adults (AYAs) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.

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 data supports the effectiveness of the Symptom Reporting Tool for Pediatric Cancer treatment?

Research shows that using tools like the Memorial Symptom Assessment Scale and Patient-Reported Outcomes Measurement Information System can help children with cancer report their symptoms accurately, leading to better symptom management and improved health outcomes. ^{1 2 3 4 5}

Is the Symptom Reporting Tool for Pediatric Cancer safe for children?

The Symptom Reporting Tool for Pediatric Cancer, which involves self-reporting of adverse events by children, has been studied for its validity and reliability, ensuring it accurately captures children's experiences. While the tool itself is not a treatment, it is designed to safely gather information about side effects from cancer treatments. ^{6 7 8 9 10}

How does the Symptom Reporting Tool for Pediatric Cancer differ from other treatments for this condition?

The Symptom Reporting Tool for Pediatric Cancer is unique because it focuses on helping children with cancer report their symptoms through a game-based app, making it easier for them to communicate their experiences. This approach is different from traditional treatments as it emphasizes symptom tracking and communication rather than directly treating the cancer itself. ^{1 4 11 12 13}

Research Team

Kimberly Pyke-Grimm

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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 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]

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]

References

1. United States 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. [2022]

2. England 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). [2021]

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

PROMIS pediatric measures validated in a longitudinal study design in pediatric oncology. [2023]

4. United States 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. [2019]

5. United States 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. [2021]

6. United States 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. [2021]

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

Validity and Reliability of the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. [2021]

8. Switzerland 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. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. [2022]

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

Validation of the caregiver Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events measure. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a game-based symptom-reporting app for children with cancer: perspectives of children and parents. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Feasibility of three times weekly symptom screening in pediatric cancer patients. [2023]

13. Germany pubmed.ncbi.nlm.nih.gov

Initial development of the Symptom Screening in Pediatrics Tool (SSPedi). [2022]