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NCT Number: NCT06824441

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Adolescent Behavior Behavior Neoplasms Oncology Pediatric Cancer

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First diagnosis of cancer
  • Receiving cancer therapy: surgery, myelosuppressive chemotherapy and/or radiation 7-21 years of age
  • 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
  • If surgery was part of treatment, the patient must be 3-6 weeks post surgery before participating in study
  • Caregiver must be present and 18 years and older
  • Ability to understand and the willingness to personally sign the written IRB-approved informed consent or assent document as appropriate
  • Disease can be newly diagnosed, in relapse or refractory, as long as this is the first diagnosis of cancer
  • Child must be able to read or listen to and understand English

Exclusion criteria

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

Treatment and study plan

Age- and Role-Specific Questionnaire Administration

Behavioral

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).

Primary outcomes

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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

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

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Symptom Reporting by Children, Adolescents and Young Adults With Cancer and Their Caregivers During a Clinic Visit: A Feasibility, Usability and Acceptability Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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