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

Stanford University

Status: Enrolling

Conditions: Oncology; Pediatric Cancer; Adolescent Behavior

Treatments: Behavioral: Age- and Role-Specific Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT06824441

IRB- 71098

NCI-2025-00233 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 7 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Behavioral: Age- and Role-Specific Questionnaire Administration