Testing a tool for children and young adults with cancer to report their symptoms
Symptom Reporting by Children, Adolescents and Young Adults With Cancer and Their Caregivers During a Clinic Visit: A Feasibility, Usability and Acceptability Study
This study is testing a new tool that helps kids and young adults with cancer share their symptoms with doctors to see how well it works for them and their families.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 7 Years to 21 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06824441 on ClinicalTrials.gov |
What this trial studies
This project aims to pilot test an electronic symptom assessment tool called the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE). The tool will be completed by children, adolescents, and young adults with cancer, along with their caregivers, and shared with clinicians during outpatient visits. The study focuses on participants aged 7-21 who are currently receiving cancer therapy and have completed at least one month of treatment. The goal is to evaluate the feasibility, usability, and acceptability of this tool in preparation for future efficacy testing.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 7-21 who have been diagnosed with cancer and are currently undergoing treatment.
Not a fit: Patients who are not proficient in English or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could enhance communication between young patients and their healthcare providers, leading to better symptom management.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving patient-reported outcomes in oncology settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Kimberly Pyke-Grimm — Stanford University
- Study coordinator: Kimberly Pyke-Grimm
- Email: kpgrimm@stanford.edu
- Phone: 650-683-5920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.