Symptom Reporting Tool for Pediatric Cancer
Recruiting in Palo Alto (17 mi)
Overseen byKimberly Pyke-Grimm
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Cognitive impairments, Memory impairments, others
No Placebo Group
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.
12345Is 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.
678910How 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.
14111213Eligibility 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.
+4 more
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
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Ped-PRO-CTCAE Questionnaire Completion for Children, AYAs, Caregivers, and CliniciansExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
The measurement of symptoms in young children with cancer: the validation of the Memorial Symptom Assessment Scale in children aged 7-12. [2022]Few studies have attempted to describe the experience of symptoms in young children with cancer. This is due, in part, to the lack of validated symptom assessment scales for this patient population. The objective of this study was to evaluate the reliability and validity of a revised Memorial Symptom Assessment Scale (MSAS) in patients aged 7-12 as an instrument for the assessment of symptoms in young children with cancer. The MSAS (7-12) was administered to 149 children (inpatients and outpatients) who were undergoing treatment at either the Royal Marsden NHS Trust, London, United Kingdom or The Children's Hospital at Westmead, Sydney, Australia. Validity was evaluated by comparison with the medical record, parental report, and concurrent assessment on visual analogue scales for selected symptoms. The data provide evidence of the reliability and validity of MSAS (7-12) and demonstrate that children with cancer as young as 7 years can report clinically relevant and consistent information about their symptom experience. Young children with cancer experience multiple symptoms. Approximately one-third had experienced lethargy and/or pain and/or insomnia during the 48 hours prior to the completion of MSAS (7-12). The completion rate for MSAS (7-12) was high and the majority of children completed the instrument in a short period of time and with little difficulty. The instrument appears to be age appropriate and may be helpful to older children unable to independently complete MSAS (10-18). Systematic symptom assessment may be useful in future epidemiological studies of symptoms and in cancer chemotherapy drug trials.
Optimising symptom management in children with cancer using a novel mobile phone application: protocol for a controlled hybrid effectiveness implementation trial (RESPONSE). [2021]Intense and aggressive treatment regimens for most children's cancer have achieved vast improvements in survival but are also responsible for both a high number and burden of symptoms. The use of Patient Reported Outcome Measures (PROMs) demonstrates a range of benefits for improved symptom management in adults with cancer. There are, however, multiple barriers to integrating PROMs into routine care in children and adolescents with cancer. This study aims to evaluate: (1) the effectiveness of electronic PROMs to generate stratified alerts, symptom management recommendations and graphical summaries (the RESPONSE system) to improve health outcomes and (2) the implementation of the RESPONSE system by assessing feasibility, acceptability, satisfaction, and sustainability.
PROMIS pediatric measures validated in a longitudinal study design in pediatric oncology. [2023]This study assessed the responsiveness to change over time and theorized associations of Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures in children and adolescents in treatment for cancer to determine measure readiness for use in cancer clinical trials.
The Pediatric Cancer Quality of Life Inventory: a modular approach to measuring health-related quality of life in children with cancer. [2019]Measurement of pediatric cancer patients' health-related quality of life (HRQL) in phase III randomized, controlled clinical trials is being recognized increasingly as an essential component in evaluating the comprehensive health outcomes of modern anti-neoplastic treatment protocols. Use of a brief core measure of HRQL plus disease-specific symptom modules is a way to assess specific HRQL outcomes with a minimum of subject burden. Demonstrating a measure's feasibility, reliability and validity also represents children's ability to provide reliable and valid responses to HRQL questions. The Pediatric Cancer Quality of Life Inventory (PCQL) Modular Approach consists of a 15-item core measure of HRQL and 2 specific symptom modules: pain and nausea. To validate a patient-report form and a parent-report form, the PCQL was administered to 291 pediatric cancer patients and to their parents. Feasibility and range of measurement, as well as patient-parent concordance, were assessed. Internal consistency reliability was assessed via Cronbach's alpha. Validity was determined by the known-groups approach and by correlating PCQL scores with days missed from school. Patients had minimal missing data, and the range of measurement for the items was good. Patient-parent concordance was large but not perfect. For both patient and parent forms, internal consistency reliability of the PCQL core scale (0.83 and 0. 86, respectively) was strong. The internal consistency reliabilities of the 2 symptom modules for both patient and parent forms were in the acceptable range for group comparisons. Regarding clinical validity, the core scale and the 2 symptom modules distinguished between patients on and off treatment for both patient and parent reports. Further, both patient and parent reports correlated with days of missed school in the past 6 and 12 months. The PCQL Modular Approach has demonstrated acceptable internal consistency reliability and clinical validity for both patient-report and parent-report forms. By implication, children are capable of providing reliable and valid responses to these HRQL questions.
Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: results from the PediQUEST randomized controlled trial. [2021]This study aimed to determine whether feeding back patient-reported outcomes (PROs) to providers and families of children with advanced cancer improves symptom distress and health-related quality of life (HRQoL).
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]Children with cancer experience significant toxicities while undergoing treatment. Documentation of adverse events (AEs) in clinical trials is mandated by federal agencies. Although many AEs are subjective, the current standard is clinician reporting. Our long-term goal is to create and validate a self-report measure of subjective AEs for children aged 7 years and older that will inform AE reporting for the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). This content validation study aimed to identify which of the AEs in the current CTCAE should be included in a pediatric self-report measure.
Validity and Reliability of the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. [2021]Patient-reported outcome (PRO) measurements linked to Common Terminology Criteria for Adverse Events (CTCAE) grading may improve symptom adverse event (AE) reporting in pediatric oncology trials. We evaluated construct validity, responsiveness, and test-retest reliability of the Ped-PRO-CTCAE measurement system for children and adolescents undergoing cancer care.
Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System. [2022]Among factors influencing the higher risk of developing unknown or rare adverse drug reactions (ADRs) among children and adolescents, there is the frequent off-label use of drugs that seems to be very common in pediatric oncological patients. Our study aim to collect and evaluate data on the safety profile of antineoplastic drugs and their off-label use in the pediatrics population using real life data.
Adolescents' understanding of chemotherapy-related adverse events: a concept elicitation study. [2022]to document adolescents' understanding of chemotherapy-related core adverse events from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events and thus begin the validation process of this tool's items with Brazilian adolescents.
Validation of the caregiver Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events measure. [2022]Despite improvements in survival rates, cancer treatments have significant side effects that affect the quality of life of children and their families. When an ill child cannot self-report symptoms (eg, he or she is too ill), caregiver (parent) reporting becomes critical. This study evaluates the validity and reliability of the caregiver-reported Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE [Caregiver]) measure.
Feasibility and acceptability of a game-based symptom-reporting app for children with cancer: perspectives of children and parents. [2023]Children with cancer have difficulty identifying and describing the multiple symptoms they experience during hospitalization and between clinical encounters. Mobile health resources, including apps, are potential solutions to support child-centric symptom reporting. This study evaluated the feasibility and acceptability of a newly developed game-based symptom-reporting app for school-age children with cancer.
Feasibility of three times weekly symptom screening in pediatric cancer patients. [2023]Primary objective was to determine the feasibility of three times weekly symptom reporting by pediatric cancer patients for eight weeks.
Initial development of the Symptom Screening in Pediatrics Tool (SSPedi). [2022]We previously identified published scales for symptom assessment in pediatric cancer patients. The objectives of this study were to identify if any of these scales were suitable for use or adaptation as a self-report symptom screening tool, and if not, to begin the process of creating a new tool.