Table 3. Study instruments.
| Baseline Packet (week -2, right after consent) | ||||||||||||||
| Most baseline tools will help characterize the study sample. | ||||||||||||||
| Respondent | Construct | Instrument | Description | |||||||||||
| Enrolled Parent | Demographics | Demographic section of the Survey about Caring for Children with Cancer (SCCC), originally developed by study investigators [34] | Age, gender, race, marital status, number of siblings (of participant child), religion, religiousness, education, zip code. | |||||||||||
| Household Material Hardship | Household Material Hardship Survey [49] | Self-report family income, child’s health insurance, health literacy, evaluation of household hardship (housing and transportation, utilities, food insecurity, and financial strain). | ||||||||||||
| Social Support | Medical Outcomes Study Social Support-Short Form [50] | 4 domains: emotional/ informational, tangible, affectionate, and positive social interaction; 8-items total. Response options: 5-point Likert type (from none of the time to most of the time). Scoring: sum of item scores. Score range: 8–40 (higher = more support). High reliability (α>0.91) and stability over time. | ||||||||||||
| Anxiety | Spielberger’s State-Trait Anxiety Scale (S-TAI)-Trait subset [41] | Measures trait anxiety (20 items); evaluates relatively stable aspects such as calmness, confidence, and security. Response options: 4-point Likert type (from almost never to almost always; scoring reversed for some items). Scoring: sum of item scores. Score range: 20–80 (higher = greater anxiety). High validity, reliability, and stability over time. | ||||||||||||
| Symptom-related stress | Stress portion of the Response to Stress Questionnaire-Pain (aRSQ-stress) [43,51] | Adapted version including 9 items that evaluate parental stress in past month related to uncertainty, meaning, treatment adherence, and effects on daily life of child symptom distress; Response options: 5-point Likert type (from no stress at all to a lot of stress). Scoring: sum of item scores. Score range: 9–45 (higher = higher stress); 1 open-ended item that asks about other sources of stress; and 1 item that assesses overall perceived control over these problems; Response options: 5-point Likert type (from no control at all to a lot of control). Score range: 1–5 (higher = greater control). High internal consistency [52]. | ||||||||||||
| Activation | Brief-COPE [44] | Adapted version (15 items) of the Brief-COPE scale evaluating parent’s use of five coping strategies relevant to symptom management using two items each: active coping, planning, instrumental support, acceptance, and self-blame. Five additional items evaluate emotional support, religion, positive reframing, behavioral disengagement, and denial. Scores on each scale (or item) range from 2 to 8, with higher scores indicating greater use of that strategy. Use of selected subscales encouraged by author. Use of single items decided after piloting instrument and finding no variability for the 2-item scales. | ||||||||||||
| PediQUEST Survey (weekly, from week -2 to week 16) | ||||||||||||||
| English and Spanish PQ-Surveys which have 5 versions (respondent- and age-adapted) that collect both parent and child reports (child from the age of five).1 Children answer the same survey version throughout the 16-weeks according to the age at time of enrollment. | ||||||||||||||
| Instruments |
PQ-Memorial Symptom Assessment Scale (PQ-MSAS) [19,39,40,53] |
Pediatric Quality of Life Inventory Generic Core Module (PedsQL 4.0™) [37,38] |
Overall Well-being [34] | |||||||||||
| Construct measured | Symptom Burden | HRQOL | General Health Perception | |||||||||||
| Instrument Characteristics | Measures presence, severity, frequency, and extent of bother in past weeks for 26 physical, psychological and 3 “other” symptoms | Assesses how much of a problem each item has been in past week (evaluates physical (7 items), and emotional, social, and school performance (5 items each)) | 1-item (“Overall, how have you been feeling during the past week?” Anchors: not well at all; extremely well) | |||||||||||
| Versions | Proxy (Parent) | Self-report | Proxy (Parent) | Self-Report |
Proxy
(Parent) |
Self-report | ||||||||
| 7–122 | 13–18 | 2–4 | 5–7 | 8–12 | 13+ | 5–7 | 8–12 | 13+ | 5–6 | >6 | ||||
| Response Types 3 | L-5 | L-4 | L-5 | L-5 | FS-3 | L-5 | VAS | FS-3 | VAS | |||||
| PQ Versions | 2–4 | |||||||||||||
| 5–6 | ||||||||||||||
| 7 | ||||||||||||||
| 8–12 | ||||||||||||||
| 13+ | ||||||||||||||
1Data from 5–12 year-olds will mainly be used for intervention delivery purposes (PediQUEST reports provide feedback on child and parent answers when available) and to analyze patient-parent concordance (see Discussion)
2 PQ-MSAS 7–12 evaluates shorter time frame (past two days) and only 8 symptoms
3Response types: L-5: 5-option Likert type; L-4: 4-option Likert type; FS-3: 3-option Faces scale; VAS: Visual analogue scale (100 mm)
4Data from pilot PQ RCT [34].