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

Not Applicable

Recruiting

• Conditions: Adolescent Behavior; Pediatric Cancer; Oncology

• Registration Number: NCT06824441
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-18
• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. First diagnosis of cancer
2. Receiving cancer therapy: surgery, myelosuppressive chemotherapy and/or radiation
3. 7-21 years of age
4. 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
5. If surgery was part of treatment, the patient must be 3-6 weeks post surgery before participating in study
6. Caregiver must be present and 18 years and older.
7. Ability to understand and the willingness to personally sign the written IRB approved informed consent or assent document as appropriate.

Exclusion Criteria

1. Child must be able to read or listen to and understand English and not have cognitive/memory impairments determined by the child's clinician
2. Caregiver must be able to read and understand English.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of Utilizing Ped-PRO-CTCAE for Clinician Access to Child/AYA and Caregiver Proxy Symptom Reports During Clinic Visits	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.
Evaluation of Usability and Acceptability of Child/Adolescent and Caregiver Symptom Reports (Ped-PRO-CTCAE) for Clinicians in an Outpatient Oncology Clinic Setting	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
Analysis of Symptom-Related Outcome Variables to Inform Sample Size Calculations for a Future Randomized Clinical Trial of the Ped-PRO-CTCAE Intervention	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States