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Active, not recruitingNCT06824441Updated Aug 12, 2026

Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer

An interventional study of Age- and Role-Specific Questionnaire Administration in Adolescent Behavior, Pediatric Cancer and Oncology, sponsored by Stanford University. Active, not recruiting at 1 site in United States. Open to participants aged 7 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Stanford University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
7 Years to 21 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Adolescent Behavior
  • Pediatric Cancer
  • Oncology
03

Who can participate

Ages eligible
7 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

1. Child must not have cognitive/memory impairments determined by the child's clinician

04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Ped-PRO-CTCAE Questionnaire Completion for Children, AYAs, Caregivers, and Clinicians

    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.

    Behavioral: Age- and Role-Specific Questionnaire Administration

Interventions

  • BehavioralAge- and Role-Specific Questionnaire Administration

    Participants will be assigned a sequence number upon eligibility confirmation. The intervention consists of completing a series of questionnaires, as follows: Child/AYA/Caregiver Group: Pre-clinic Visit: 3 questionnaires (approximately 15-20 minutes total). Post-clinic Visit: 2 questionnaires (approximately 5-10 minutes total). Clinician Group: Post-clinic Visit: 2 questionnaires (approximately 5 minutes total).

05

What researchers measure

Primary outcomes

  1. Feasibility of Utilizing Ped-PRO-CTCAE for Clinician Access to Child/AYA and Caregiver Proxy Symptom Reports During Clinic Visits

    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.

    Time frame: 1 year

  2. Evaluation of Usability and Acceptability of Child/Adolescent and Caregiver Symptom Reports (Ped-PRO-CTCAE) for Clinicians in an Outpatient Oncology Clinic Setting

    To evaluate the usability and acceptability of providing the child/adolescent and caregiver symptom reports (Ped-PRO-CTCAE) to the clinician in an outpatient oncology clinic setting

    Time frame: 1 year

  3. Analysis of Symptom-Related Outcome Variables to Inform Sample Size Calculations for a Future Randomized Clinical Trial of the Ped-PRO-CTCAE Intervention

    To describe and analyze symptom-related outcome variables that will assist in sample size calculations for a future randomized clinical trial of the Ped-PRO-CTCAE intervention.

    Time frame: 1 year

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Study locations

1 site
  • Stanford University
    Palo Alto, California 94304, United States
07

Registry details

Key details

Study ID
NCT06824441
Lead sponsor
Stanford University
Responsible party
Sponsor
First posted
Feb 13, 2025
Start date
Aug 18, 2024
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Aug 12, 2026

Study contacts

Kimberly Pyke-Grimm
principal investigator · Stanford University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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