ClinicalTrials.gg
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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
7 Years to 21 Years
Sex
All
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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.

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Conditions studied

  • Adolescent Behavior
  • Pediatric Cancer
  • Oncology
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In context

Adolescent Behavior

305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.

This study's enrollment of 85 is below the median of 172 across 256 interventional studies indexed under Adolescent Behavior.

Browse Adolescent Behavior studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 or assent document as appropriate
  7. Disease can be newly diagnosed, in relapse or , 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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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).

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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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06824441
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 ↗

Not currently enrolling

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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Discussion

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