Trial Outcomes & Findings for Treating Pain in Children With Cancer: Pain Buddy (NCT NCT03384134)

Children and caregivers were recruited in oncology outpatient clinics and inpatient floors at both hospitals (CHOC Children's and St Jude Children's Research Hospital) between August 1, 2019 and May 2, 2024. The Pain Buddy app was designed for child use, thus, only the child was randomized to an arm. These numbers reflect the revised protocol included in this record. The originally reported phases (1, 2, and RCADS sample) have been removed, thus no data is available for reporting.

Caregivers only completed outcome assessments. Although the protocol references additional samples, this group was never recruited separately. All children randomized to either arm of the study completed the RCADS measure.

Parent sex is unknown/not collected from parents

As part of the daily electronic Pain Buddy diary, children were administered the Memorial Symptoms Assessment Scale. Children 8-9 years of age received an 8-item instrument and were asked to report frequency (i.e. a very short time, a medium amount, almost all the time) severity (i.e. a little, a medium amount, very), and how distressful (i.e. not at all, a little, a medium amount, very) each symptom was. Children 10-18 years of age received a 30-item instrument and were asked to report how often (i.e. almost never, sometimes, a lot, almost always), how severe (i.e. slight, moderate, severe, very severe), and how distressful (i.e. not at all, a little bit, somewhat, quite a bit, very much) each symptom was. The items related to pain severity were used to calculate a 0-10 continuous score of self-reported pain severity for participants in each group. For this outcome, lower scores represent improvement in pain severity.

Medication Attitude Questionnaire (MAQ) (parent self-report). This questionnaire was developed to examine attitudes about using pain medication for treating children's pain. The instrument consists of 16 items each rated on a seven-point Likert-type scale that ranges from strongly disagree to strongly agree. The factors were Appropriate-Use, Side-Effects (e.g., "Side effects are something to worry about when giving children pain medication"), and Avoidance (e.g., "Pain medication works best if saved for when the pain is quite bad"). Scores for the side effects scale range from 5-35. Scores for Avoidance range from 7-49. Scores for Appropriate Use range from 4-28 A total score reflective of misconceptions is calculated by summing all the subscales. The total score ranges from 16-112 with higher scores indicating more negative attitudes towards use of pain medication.

Perceived Stress Scale (PSS) (parent self-report) The PSS is a widely used 14-item self-report measure of perceived stress. Parents will be asked to rate statements such as "In the past month, how often have you been upset because of something that happened unexpectedly?" and "In the past month how often have you felt that things were going your way?" Subjects rate the items on a 5-point Likert-type scale. Seven items are reverse-keyed and items are summed to obtain the final score. Total scores range from 0-56. Higher scores reflect greater perceived stress. The PSS has been shown to have adequate reliability and validity. Completed at baseline, 60 days, and 6 month follow-up using REDCap

State-Trait Anxiety Inventory (STAI) (parent self-report). This is a widely used self-report anxiety assessment instrument for adults.The questionnaire contains two separate, 20-item, 4-point self-report rating scales for measuring trait and state anxiety. TOTAL scores are summed for situational and trait anxiety. Scores range from 20 to 80 each; higher scores denote higher levels of anxiety. For our purposes, only the one page Trait section of the questionnaire will be administered and utilized. Completed at baseline (T1) using REDCap. Scores from 20-37 indicate low anxiety, 38-44 indicate moderate anxiety, and 45-80 indicate high anxiety.

The Revised Child Anxiety and Depression Scale (RCADS) -Child's self report on 47-item scale with subscales including separation anxiety, social phobia, generalized anxiety, panic disorder, obsessive compulsive disorder, and major depression. Items are rated on a 4-point Likert scale from 0 ("never") to 3 ("always"). Higher scores suggest higher levels of anxiety and depression. TOTAL Scores range from 0-141.

Children and parents are asked to report on the child's health related quality of life. The measure incorporates a generic (divided into 4 categories: physical, emotional, social and school), cancer (divided into 8 categories: pain \& hurt, nausea, procedural anxiety, treatment anxiety, cognitive problems, perceived physical appearance and communication), and fatigue module (divided into 3 categories: general fatigue, sleep/rest fatigue, cognitive fatigue). Higher scores on the scale suggest a better health related quality of life. Questions are asked on a 5-point likert scale ranging from 0=never to 4=almost always. Scores are transformed from 0-100. TOTAL scores for each module range from 0-100 on the PedsQL.