Symptom Reporting by Children, Adolescents and Young Adults With Cancer and Their Caregivers During a Clinic Visit: A Feasibility, Usability and Acceptability Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Stanford University
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Feasibility of Utilizing Ped-PRO-CTCAE for Clinician Access to Child/AYA and Caregiver Proxy Symptom Reports During Clinic Visits
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •1. Child must not have cognitive/memory impairments determined by the child's clinician
Arms & Interventions
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.
Intervention: Age- and Role-Specific Questionnaire Administration (Behavioral)
Outcomes
Primary Outcomes
Feasibility of Utilizing Ped-PRO-CTCAE for Clinician Access to Child/AYA and Caregiver Proxy Symptom Reports During Clinic Visits
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported