Adolescent BehaviorNCT06824441
Feasibility Usability & Acceptability Study: Symptom Reporting by Children Adolescents & Young Adults w/Cancer
A study testing Age- and Role-Specific Questionnaire Administration in people with Adolescent Behavior and Pediatric Cancer, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Adolescent Behavior, Pediatric Cancer, Oncology
- What is being tested?
- Age- and Role-Specific Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 1. Child must not have cognitive/memory impairments determined by the child's clinician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptom Reporting by Children, Adolescents and Young Adults With Cancer and Their Caregivers During a Clinic Visit: A Feasibility, Usability and Acceptability Study
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
- Being tested
- Age- and Role-Specific Questionnaire Administration
- Medical subject headings
- Adolescent Behavior, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Age- and Role-Specific Questionnaire AdministrationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Age- and Role-Specific Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start18 Aug 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly Pyke-Grimm, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824441
- Sponsor's protocol ID
- IRB-71098
- Other IDs
- NCI-2025-00233
- Status last verified
- Aug 2026
- First submitted
- 7 Feb 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Reporting by Children, Adolescents and Young Adults With Cancer and Their Caregivers During a Clinic Visit: A Feasibility, Usability and Acceptability Study
- ClinicalTrials.gov ID
- NCT06824441
- Acronym / sponsor ID
- IRB-71098
- Conditions
- Adolescent Behavior, Pediatric Cancer, Oncology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ped-PRO-CTCAE Questionnaire Completion for Children, AYAs, Caregivers, and Clinicians | Experimental | Behavioral: Age- and Role-Specific Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Child must not have cognitive/memory impairments determined by the child's clinician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Age- and Role-Specific Questionnaire AdministrationParticipants 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). | Behavioural | Ped-PRO-CTCAE Questionnaire Completion for Children, AYAs, Caregivers, and Clinicians |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Pyke-Grimm principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Age- and Role-Specific Questionnaire Administration in people with Adolescent Behavior and Pediatric Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Utilizing Ped-PRO-CTCAE for Clinician Access to Child/AYA and Caregiver Proxy Symptom Reports During Clinic Visits (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.