Symptom Trajectory Approaches to Research

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.

• Health surveys (Other): Participants will complete several surveys about their quality of life and health.

Primary outcomes

• Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) [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.

Secondary outcomes

• Change in PROMIS Pediatric Global Health 7 [Baseline, bi-weekly for 4 months]: 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.
• Change in PROMIS Pediatric Mobility - Short Form 7a [Baseline, bi-weekly for 4 months]: 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.
• Change in PROMIS Pediatric Physical Stress Experiences - Short Form 8a [Baseline, bi-weekly for 4 months]: 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.

Sex: All, ages: 8 Years to 18 Years

Inclusion Criteria - Children:

* 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

Inclusion Criteria - Caregivers:

* Aged >18
* Caregiver of a child diagnosed with advanced cancer
* English or Spanish literate
* Identified as being substantially involved in caring for the child

Exclusion Criteria:

* Any condition that would prevent participants from completing surveys

• 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

NIH grants: R01CA307143