Advanced CancerSTARNCT07804875
Symptom Trajectory Approaches to Research
An observational study of Advanced Cancer and Metastatic Disease, run by University of Wisconsin, Madison at 5 sites in United States.
Trial summary
The goal of this observational study is to understand how cancer makes children feel over time. The main things the researchers hope to learn are: When and how often do children have different feelings or sickness; Why do these feelings happen; and, How these feelings change a child's overall health. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Advanced Cancer, Metastatic Disease, Cancer Treatment
- What is being tested?
- Health surveys
- How many people
- 228 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Dec 2026to 31 May 2031
- Phase
- Observational
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Potential participants will be identified through the pediatric hematology/oncology research team and/or clinicians.
Who may be able to join
- Aged 8-18 years
- Diagnosis of advanced cancer of any type made by the hematology, oncology, or cellular therapy team
- Undergoing cancer treatment or comfort care
- Be English or Spanish literate
- Aged >18
- Caregiver of a child diagnosed with advanced cancer
- English or Spanish literate
- Identified as being substantially involved in caring for the child
Who cannot join
- Any condition that would prevent participants from completing surveys
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sabrina Cordon-Royer contact
5 sites in 1 country
United States5 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital Los Angeles
Los Angeles, California, 90027
American Family Children's Hospital
Madison, Wisconsin, 53705
New York -Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
OHSU Doernbecher Children's Hospital
Portland, Oregon, 97239
About this study
Official title: Defining Symptom Trajectories to Inform Risk-Stratified Approaches to Symptom Management in Children With Advanced Cancer
The goal of this observational study is to understand how cancer makes children feel over time. The main things the researchers hope to learn are:
- When and how often do children have different feelings or sickness;
- Why do these feelings happen; and,
- How these feelings change a child's overall health.
Participants will answer simple surveys about their health.
Read the detailed description
The use of conventional and novel therapeutics to treat children with advanced cancer leads to burdensome physical and psychological symptoms. Advanced cancer is metastatic upon initial diagnosis, relapsed, progressed, or refractory to treatment, resulting in an uncertain and prolonged disease course. Symptom burden and associated suffering are amplified for these children due to disease burden, intense therapy, and often lengthy treatment. Symptom patterns (trajectories) have been identified in children diagnosed with early-stage cancer, but research characterizing symptom patterns over time in the understudied patient population of children with advanced cancer is sparse.
- Conditions
- Advanced Cancer, Metastatic Disease, Cancer Treatment, Progressive Disease, Recurrent Cancer
- Being tested
- Health surveys
- Keywords
- Undergoing cancer treatment, undergoing cancer comfort care
- Medical subject headings
- Neoplasm Metastasis, Disease Progression, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health surveysOther
Participants will complete several surveys about their quality of life and health.
| Study group | Role | What they receive |
|---|---|---|
| Children with advanced cancer | Not described Receives: Other: Health surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
Ped-PRO-CTCAE evaluates pediatric cancer symptoms using patient or caregiver reports scored on a 0-to-3 scale across attributes like frequency, severity, and interference. 38 items are scored 0-3, where 0 = never (or equivalent) and 3 = all the time (or equivalent). Scores range from 0 to 114, with higher scores indicating worse symptoms. This score will be used to measure the trajectory of symptoms over time.
Measured: Baseline, bi-weekly for 4 months
Secondary outcomes (3)
Change in PROMIS Pediatric Global Health 7
PROMIS Pediatric Global Health 7 is a 7-item survey used to measure overall physical, mental, and social health in children and adolescents. It is scored using a 5-point Likert scale, where 1 = poor and 5 = excellent. Scores range from 7 to 35, with higher scores indicating better global health.
Measured: Baseline, bi-weekly for 4 months
Change in PROMIS Pediatric Mobility - Short Form 7a
PROMIS Pediatric Mobility is a 7-item questionnaire that evaluates self-perceived physical mobility and functioning in children and adolescents. It uses a 5-point Likert scale ranging from "Without no trouble" to "Not able to do". Raw scores range from 7 to 35. Raw scores are translated into normalized T-scores with a US population-level mean of 50 and a standard deviation (SD) of 10. A T-score of 50 represents average mobility for the general population. Scores above 50 mean better-than-average mobility, while scores below 50 indicate greater impairment.
Measured: Baseline, bi-weekly for 4 months
Change in PROMIS Pediatric Physical Stress Experiences - Short Form 8a
PROMIS Physical Stress Experiences is an 8-item questionnaire designed to measure physical symptoms of stress in children and adolescents. It is scored by summing the raw item responses (ranging from 8 to 40) and converting that total into a standardized T-score. The raw score maps to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10 for the general population. Higher T-scores reflect a greater level of physical stress.
Measured: Baseline, bi-weekly for 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 May 2031 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Nationwide Children's Hospital, Oregon Health and Science University, Children's Hospital Los Angeles, New York Presbyterian Hospital, OHSU Doernbecher Children's Hospital, Columbia University
- Responsible party
- Sponsor
- Investigators
- Kathleen (Kitty) Montgomery, PhD, RN, PCNS-BC, Principal investigator, University of Wisconsin, MadisonKristine Kwekkeboom, PhD, RN, FAAN, Principal investigator, University of Wisconsin, MadisonRoger Brown, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804875
- Sponsor's protocol ID
- 2026-0259
- Other IDs
- 1R01CA307143, Protocol Version 2/11/26, UWMSN | Nursing | Administrati
- Acronym
- STAR
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Symptom Trajectories to Inform Risk-Stratified Approaches to Symptom Management in Children With Advanced Cancer
- ClinicalTrials.gov ID
- NCT07804875
- Acronym / sponsor ID
- STAR / 2026-0259
- Conditions
- Advanced Cancer, Metastatic Disease, Cancer Treatment, Progressive Disease, Recurrent Cancer
- Keywords
- Undergoing cancer treatment, undergoing cancer comfort care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Nationwide Children's Hospital, Oregon Health and Science University, Children's Hospital Los Angeles, New York Presbyterian Hospital, OHSU Doernbecher Children's Hospital, Columbia University
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 May 2031 (estimated)
- First posted
- 4 Sep 2026 (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 goal of this observational study is to understand how cancer makes children feel over time. The main things the researchers hope to learn are:
- When and how often do children have different feelings or sickness;
- Why do these feelings happen; and,
- How these feelings change a child's overall health.
Participants will answer simple surveys about their health.
Detailed description
The use of conventional and novel therapeutics to treat children with advanced cancer leads to burdensome physical and psychological symptoms. Advanced cancer is metastatic upon initial diagnosis, relapsed, progressed, or refractory to treatment, resulting in an uncertain and prolonged disease course. Symptom burden and associated suffering are amplified for these children due to disease burden, intense therapy, and often lengthy treatment. Symptom patterns (trajectories) have been identified in children diagnosed with early-stage cancer, but research characterizing symptom patterns over time in the understudied patient population of children with advanced cancer is sparse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with advanced cancer | – | Other: Health surveys |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Potential participants will be identified through the pediatric hematology/oncology research team and/or clinicians.
Key inclusion criteria (8 listed)
- Aged 8-18 years
- Diagnosis of advanced cancer of any type made by the hematology, oncology, or cellular therapy team
- Undergoing cancer treatment or comfort care
- Be English or Spanish literate
- Aged >18
Key exclusion criteria (1 listed)
- Any condition that would prevent participants from completing surveys
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 |
|---|---|---|
| Health surveysParticipants will complete several surveys about their quality of life and health. | Other | Children with advanced cancer |
Primary outcome
Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
Time frame: Baseline, bi-weekly for 4 months
Ped-PRO-CTCAE evaluates pediatric cancer symptoms using patient or caregiver reports scored on a 0-to-3 scale across attributes like frequency, severity, and interference. 38 items are scored 0-3, where 0 = never (or equivalent) and 3 = all the time (or equivalent). Scores range from 0 to 114, with higher scores indicating worse symptoms. This score will be used to measure the trajectory of symptoms over time.
3 secondary outcomes
Change in PROMIS Pediatric Global Health 7
Time frame: Baseline, bi-weekly for 4 months
Change in PROMIS Pediatric Mobility - Short Form 7a
Time frame: Baseline, bi-weekly for 4 months
Change in PROMIS Pediatric Physical Stress Experiences - Short Form 8a
Time frame: Baseline, bi-weekly for 4 months
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 4 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Sabrina Cordon-Royer contact
Kathleen (Kitty) Montgomery, PhD, RN, PCNS-BC principal investigator
University of Wisconsin, Madison
Kristine Kwekkeboom, PhD, RN, FAAN principal investigator
University of Wisconsin, Madison
Roger Brown, PhD principal investigator
University of Wisconsin, Madison
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Metastatic Disease, run by University of Wisconsin, Madison at 5 sites 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: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Contact Sabrina Cordon-Royer (cordonroyer@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) (time frame: Baseline, bi-weekly for 4 months). 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 4 Sep 2026.