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

NCT06824441 | Active Not Recruiting

• 2 other identifiers: IRB- 71098NCI-2025-00233
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Adolescent Behavior; Pediatric Cancer; Oncology

Outcome Measures

Primary Outcomes (3)

• 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.

  1 year

• 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

  1 year

• 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.

  1 year

Study Arms (1)

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

EXPERIMENTAL

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

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).

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

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Neoplasms

Interventions

Aging

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Kimberly Pyke-Grimm

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: August 18, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)