Pediatric Oncology, Quality of Life
Conditions
Keywords
Pediatric Oncology, Randomized Control Trial, Symptom Screening, Quality of Life
Brief summary
Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application which builds upon the Symptom Screening in Pediatrics Tool (SSPedi) and consists of two components: (1) a symptom screening component centered on SSPedi; and (2) a supportive care clinical practice guideline (CPG) component. This proposal is a randomized controlled trial that compares daily completion of SSPedi via SPARK for 5 days with symptom feedback to healthcare providers compared with standard of care
Detailed description
Participants will be children with cancer or hematopoietic stem cell transplantation (HSCT) recipients who are 8-18 years of age and who can understand English, and who are expected to be in hospital or in clinic daily for 5 days. This will be a multi-center RCT in which we will randomize children to either undergo daily symptom screening for 5 days with symptom reports provided to the healthcare team or standard of care. The primary outcome will be the self-reported day 5 total SSPedi score (range 0-60; higher worse). Secondary outcomes will be the day 5 self-reported individual symptom, pain and QoL scores, and documentation of symptoms and provision of interventions for symptoms over the 5 day trial. We will enroll 345 participants over 4 years from 7 Canadian centers
Interventions
OTHERSPARK
see above
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 8 to 18 years of age * Diagnosis of cancer or have received or about to receive HSCT * Understand English * Expected to be in hospital or clinic for 5 day
Exclusion criteria
* illness severity * cognitive disability * visual impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSPedi (Symptom Screening in Pediatrics) Total Scores | Measure will be completed by all participants at baseline (day 1) and day 5±1 day. | The primary outcome will be the self-reported total SSPedi score on day 5. The total SSPedi score is a validated measure that reflects the total burden of bothersome symptoms experienced. The total score is the sum of each of the 15 items' Likert scores which range from 0 (not at all bothered) to 4 (extremely bothered) to yield a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | Measure will be completed by all participants on baseline (day 1) and day 5±1 day. | The subscale SSPedi score is a validated measure that reflects the burden of a bothersome symptom experienced. Each of the 15 symptoms assessed by the SSPedi questionnaire will serve as secondary outcomes. The subscale uses a Likert score that ranges from 0 (not at all bothered) to 4 (extremely bothered). The reported values represent the number of participants who had symptoms rated as severely bothersome, defined as a score of 3 or 4 on the subscale. Higher reported scores indicate a higher number of participants that reported the level of bother for that symptom as a 3 or a 4. |
| Faces Pain Scale-Revised | Measure will be completed by all participants on day 1 (baseline) and day 5±1 day | Self-reported pain will be assessed using the Faces Pain Scale-Revised which consists of a series of horizontal faces that depict a neutral facial expression of no pain on the left and worst pain on the right. It has 6 faces and may be scored on a 0 to 10 scale in which higher numbers denote more pain. |
| PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | Measure will be completed by all participants on day 1 (baseline) and day 5±1 day | Self-reported QoL will be measured using the PedsQL 3.0 Acute Cancer Module. This measure is a multidimensional instrument that is reliable and valid in children with cancer. It assesses pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance and communication. The self-report 7-day recall version will be used. The problems are rated from 0; never a problem to 4 if it is almost always a problem. They produce 8 domain scores ranging from 0 to 100, with higher scores denote better health. |
Countries
Canada
Participant flow
Pre-assignment details
No participants were enrolled but excluded from assignment to study groups.
Participants by arm
| Arm | Count |
|---|---|
| SPARK Intervention Participants will complete symptom screening using SPARK once daily on a study-supplied iPad. For inpatients, daily reminders to complete SSPedi will appear on the iPad. Reports will be available to the child at any time. For outpatients, clinical research associates will provide the iPad in person daily and reports may be viewed at those encounters. The intervention is daily symptom screening with provision of reports to the healthcare team. Severe symptoms will result in email alerts. More specifically, SSPedi reports will be printed daily and provided in the patient chart. On days 1 and 3, an alert will be emailed to the physician providing direct medical care if any symptom is a lot or extremely bothersome (score 3 or 4 on 0-4 scale). Reports and alerts will have links to SPARK-housed CPGs.
SPARK: see above | 176 |
| Standard of Care Arm Participants randomized to the control arm will not complete daily symptom screening. They will complete SSPedi on days 1 and 5 to obtain the primary outcome. Health care providers will not be notified of their SSPedi scores and no symptom reports or symptom alerts will be generated. | 169 |
| Total | 345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | SPARK Intervention | Standard of Care Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 176 Participants | 169 Participants | 345 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 13.9 years | 13.6 years | 13.8 years |
| Race/Ethnicity, Customized Aboriginal | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Arab or West Asian | 10 Participants | 13 Participants | 23 Participants |
| Race/Ethnicity, Customized Asian | 53 Participants | 27 Participants | 80 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized Latin American | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Other race or mixed race | 20 Participants | 20 Participants | 40 Participants |
| Race/Ethnicity, Customized Prefer not to say | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown or missing | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 78 Participants | 92 Participants | 170 Participants |
| Region of Enrollment Canada | 176 participants | 169 participants | 345 participants |
| Sex: Female, Male Female | 76 Participants | 74 Participants | 150 Participants |
| Sex: Female, Male Male | 100 Participants | 95 Participants | 195 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 176 | 0 / 169 |
| other Total, other adverse events | 0 / 176 | 0 / 169 |
| serious Total, serious adverse events | 0 / 176 | 0 / 169 |
Outcome results
Primary
SSPedi (Symptom Screening in Pediatrics) Total Scores
The primary outcome will be the self-reported total SSPedi score on day 5. The total SSPedi score is a validated measure that reflects the total burden of bothersome symptoms experienced. The total score is the sum of each of the 15 items' Likert scores which range from 0 (not at all bothered) to 4 (extremely bothered) to yield a total score that ranges from 0 (no bothersome symptoms) to 60 (worst bothersome symptoms).
Time frame: Measure will be completed by all participants at baseline (day 1) and day 5±1 day.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPARK Intervention | SSPedi (Symptom Screening in Pediatrics) Total Scores | SSPedi Baseline Total Scores | 13.2 score on a scale | Standard Deviation 8 |
| SPARK Intervention | SSPedi (Symptom Screening in Pediatrics) Total Scores | SSPedi Day 5 Total Scores | 10.2 score on a scale | Standard Deviation 7.4 |
| Standard of Care Arm | SSPedi (Symptom Screening in Pediatrics) Total Scores | SSPedi Baseline Total Scores | 13.1 score on a scale | Standard Deviation 8.2 |
| Standard of Care Arm | SSPedi (Symptom Screening in Pediatrics) Total Scores | SSPedi Day 5 Total Scores | 12.7 score on a scale | Standard Deviation 8.3 |
Secondary
Faces Pain Scale-Revised
Self-reported pain will be assessed using the Faces Pain Scale-Revised which consists of a series of horizontal faces that depict a neutral facial expression of no pain on the left and worst pain on the right. It has 6 faces and may be scored on a 0 to 10 scale in which higher numbers denote more pain.
Time frame: Measure will be completed by all participants on day 1 (baseline) and day 5±1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPARK Intervention | Faces Pain Scale-Revised | Face Pain Scale-Revised score baseline | 1.6 score on a scale | Standard Deviation 1.9 |
| SPARK Intervention | Faces Pain Scale-Revised | Face Pain Scale-Revised score day 5 | 1.7 score on a scale | Standard Deviation 2.1 |
| Standard of Care Arm | Faces Pain Scale-Revised | Face Pain Scale-Revised score baseline | 1.4 score on a scale | Standard Deviation 1.9 |
| Standard of Care Arm | Faces Pain Scale-Revised | Face Pain Scale-Revised score day 5 | 1.4 score on a scale | Standard Deviation 1.9 |
Secondary
Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom
The subscale SSPedi score is a validated measure that reflects the burden of a bothersome symptom experienced. Each of the 15 symptoms assessed by the SSPedi questionnaire will serve as secondary outcomes. The subscale uses a Likert score that ranges from 0 (not at all bothered) to 4 (extremely bothered). The reported values represent the number of participants who had symptoms rated as severely bothersome, defined as a score of 3 or 4 on the subscale. Higher reported scores indicate a higher number of participants that reported the level of bother for that symptom as a 3 or a 4.
Time frame: Measure will be completed by all participants on baseline (day 1) and day 5±1 day.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Throwing up or feeling like you may throw up baseline | 17 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling sad or dissapointed baseline | 18 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling scared or worried baseline | 18 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling cranky or angry baseline | 10 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Problems thinking or remembering things baseline | 11 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Changes in how your body or face look baseline | 16 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling tired baseline | 55 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Mouth sores baseline | 12 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Headache baseline | 10 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Hurt or pain (other than headache) baseline | 24 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Tingly or numb hands or feet baseline | 10 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling more or less hungry than you usually do baseline | 40 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Changes in taste baseline | 24 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Constipation baseline | 16 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Diarrhea baseline | 15 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling dissapointed or sad day 5 | 8 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling scared or worried day 5 | 4 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling cranky or angry day 5 | 8 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Problems with thinking or remembering things day 5 | 2 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Changes in how your body or face look day 5 | 9 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling tired day 5 | 31 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Mouth sores day 5 | 9 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Headache day 5 | 8 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Hurt or pain day 5 | 15 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Tingly or numb hands or feet day 5 | 4 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Throwing up or feeling like you may throw up day 5 | 17 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling more or less hungry than you usually do day 5 | 21 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Changes in taste day 5 | 14 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Constipation day 5 | 6 Participants |
| SPARK Intervention | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Diarrhea day 5 | 8 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Headache day 5 | 8 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Constipation baseline | 10 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling dissapointed or sad day 5 | 10 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling sad or dissapointed baseline | 11 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling more or less hungry than you usually do day 5 | 35 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling scared or worried baseline | 17 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling scared or worried day 5 | 6 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling cranky or angry baseline | 11 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Hurt or pain day 5 | 22 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Problems thinking or remembering things baseline | 8 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling cranky or angry day 5 | 16 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Changes in how your body or face look baseline | 15 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Constipation day 5 | 14 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling tired baseline | 54 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Problems with thinking or remembering things day 5 | 9 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Mouth sores baseline | 9 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Tingly or numb hands or feet day 5 | 4 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Headache baseline | 11 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Changes in how your body or face look day 5 | 18 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Hurt or pain (other than headache) baseline | 24 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Changes in taste day 5 | 18 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Tingly or numb hands or feet baseline | 5 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Throwing up or feeling like you may throw up baseline | 19 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling tired day 5 | 53 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Feeling more or less hungry than you usually do baseline | 30 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Throwing up or feeling like you may throw up day 5 | 23 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Changes in taste baseline | 19 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Mouth sores day 5 | 12 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Diarrhea day 5 | 11 Participants |
| Standard of Care Arm | Number of Participants With a Self-reported Severely Bothersome SSPedi (Symptom Screening in Pediatrics) Score Per Symptom | SSPedi: Diarrhea baseline | 11 Participants |
Secondary
PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module
Self-reported QoL will be measured using the PedsQL 3.0 Acute Cancer Module. This measure is a multidimensional instrument that is reliable and valid in children with cancer. It assesses pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance and communication. The self-report 7-day recall version will be used. The problems are rated from 0; never a problem to 4 if it is almost always a problem. They produce 8 domain scores ranging from 0 to 100, with higher scores denote better health.
Time frame: Measure will be completed by all participants on day 1 (baseline) and day 5±1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Pain and hurt baseline | 66.5 score on a scale | Standard Deviation 26.5 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Nausea baseline | 69.2 score on a scale | Standard Deviation 22.2 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Procedural Anxiety baseline | 65.5 score on a scale | Standard Deviation 29.4 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Treatment Anxiety baseline | 77.0 score on a scale | Standard Deviation 25.7 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Worry baseline | 62.4 score on a scale | Standard Deviation 26.9 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Cognitive problems baseline | 69.7 score on a scale | Standard Deviation 21.3 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Perceived physical appearance baseline | 75.3 score on a scale | Standard Deviation 24.4 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Communication baseline | 72.9 score on a scale | Standard Deviation 22.7 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Pain and hurt day 5 | 73.1 score on a scale | Standard Deviation 22.6 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Nausea day 5 | 69.2 score on a scale | Standard Deviation 21.8 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Procedural anxiety day 5 | 69.5 score on a scale | Standard Deviation 29.9 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Treatment anxiety day 5 | 80.5 score on a scale | Standard Deviation 23.7 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Worry day 5 | 68.7 score on a scale | Standard Deviation 26.2 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Cognitive problems day 5 | 74.2 score on a scale | Standard Deviation 21.4 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Percieved physical appearance day 5 | 79.2 score on a scale | Standard Deviation 22.6 |
| SPARK Intervention | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Communication day 5 | 76.4 score on a scale | Standard Deviation 22.3 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Communication day 5 | 78.1 score on a scale | Standard Deviation 21.2 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Pain and hurt baseline | 68.3 score on a scale | Standard Deviation 26.5 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Pain and hurt day 5 | 72.8 score on a scale | Standard Deviation 26.1 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Nausea baseline | 71.6 score on a scale | Standard Deviation 20.7 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Worry day 5 | 69.1 score on a scale | Standard Deviation 25.4 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Procedural Anxiety baseline | 63.8 score on a scale | Standard Deviation 32.7 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Nausea day 5 | 69.5 score on a scale | Standard Deviation 31.8 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Treatment Anxiety baseline | 78.6 score on a scale | Standard Deviation 25.8 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Percieved physical appearance day 5 | 78.2 score on a scale | Standard Deviation 25.5 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Worry baseline | 62.9 score on a scale | Standard Deviation 27 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Procedural anxiety day 5 | 66.5 score on a scale | Standard Deviation 31.8 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Cognitive problems baseline | 70.1 score on a scale | Standard Deviation 21.3 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Cognitive problems day 5 | 74.4 score on a scale | Standard Deviation 21.3 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Perceived physical appearance baseline | 75.4 score on a scale | Standard Deviation 26.2 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Treatment anxiety day 5 | 81.9 score on a scale | Standard Deviation 23.5 |
| Standard of Care Arm | PedsQL (Pediatric Quality of Life) 3.0 Acute Cancer Module | PedsQL 3.0 Communication baseline | 75.1 score on a scale | Standard Deviation 23.1 |