Clinical trial · Interventional
Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer
Symptom Reporting by Children, Adolescents and Young Adults With Cancer and Their Caregivers During a Clinic Visit: A Feasibility, Usability and Acceptability Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adolescent Behavior | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Age- and Role-Specific Questionnaire Administration | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ped-PRO-CTCAE Questionnaire Completion for Children, AYAs, Caregivers, and Clinicians
- description
- 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.
- interventionNames
- Behavioral: Age- and Role-Specific Questionnaire Administration
Primary outcomes (3)
- measure
- Feasibility of Utilizing Ped-PRO-CTCAE for Clinician Access to Child/AYA and Caregiver Proxy Symptom Reports During Clinic Visits
- timeFrame
- 1 year
- description
- To determine the feasibility of providing clinicians with child/AYA and caregiver (proxy) subjective symptom reports using the validated Ped-PRO-CTCAE items during a clinic visit.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. First diagnosis of cancer 2. Receiving cancer therapy: surgery, myelosuppressive chemotherapy and/or radiation 7-21 years of age 3. Completed at least 1 month of cancer chemotherapy treatment and are within 7-28 days of starting a treatment cycle or during ongoing therapy, followed at least every month in clinic 4. If surgery was part of treatment, the patient must be 3-6 weeks post surgery before participating in study 5. Caregiver must be present and 18 years and older 6. Ability to understand and the willingness to personally sign the written IRB-approved informed consent or assent document as appropriate 7. Disease can be newly diagnosed, in relapse or refractory, as long as this is the first diagnosis of cancer 8. Child must be able to read or listen to and understand English Exclusion Criteria: 1\. Child must not have cognitive/memory impairments determined by the child's clinician
References
Publications (0)
Data not yet available