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

NCT ID: NCT06824441

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-18
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Age- and Role-Specific Questionnaire Administration

Intervention Type: 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).

Interventions

Age- 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly Pyke-Grimm

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kimberly Pyke-Grimm

Role: CONTACT

kpgrimm@stanford.edu

650-683-5920

Facility Contacts

Kimberly Pyke-Grimm, PhD, RN, CNS, CPHON

Role: primary

kpgrimm@stanford.edu

Other Identifiers

NCI-2025-00233

Identifier Type: OTHER

Identifier Source: secondary_id

IRB- 71098

Identifier Type: -

Identifier Source: org_study_id