Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial

Primary outcomes

1. Pain intensity

   Time frame: Up to 8 weeks from start of study

   The Brief Pain Inventory-Short Form (BPI) includes a 4-item pain severity scale. Participants rate their worst and least pain in the last 24 hours, average pain, and current pain. This measure includes a body diagram to allow participants to indicate where they experience the most pain and has a 10-point rating scale (No Pain to Pain As Bad As You Can Imagine). The higher scores indicate greater pain. The Brief Pain Inventory pain intensity has good internal consistency in survivors of childhood cancer (α=0.87).

2. Pain interference

   Time frame: Up to 8 weeks from start of study

   The Functional Disability Inventory (FDI) is a 15-item measure assessing difficulty performing daily activities in home, school, and social domains with higher scores indicating greater pain-related disability. The measure has a 4-point rating scale (No Trouble to Impossible) for performing daily activities. The Functional Disability Inventory has good internal consistency (α=0.85-0.92) and test-retest reliability (r=0.48-0.80).

3. Pain catastrophizing

   Time frame: Up to 8 weeks from start of study

   The Pain Catastrophizing Scale, Child version (PCS-C) is a 13-item self-report measure of overly negative attitudes of pain and it consists of three scales of rumination, magnification and helplessness. The 5-point rating scale (Not at All to Extremely). Higher scores indicate more pain catastrophizing. This measure has good reliability (Cronbach's α=0.90) in a clinical sample of children and adolescents with chronic or recurrent pain.

4. Depression

   Time frame: Up to 8 weeks from start of study

   The PROMIS Pediatric Depressive Symptoms is an 8-item measure of self-reported symptoms of low mood in children and adolescents over the past 7 days. The measure has a 5-point rating scale (Never to Almost Never). Higher scores indicate greater symptoms.

5. Anxiety

   Time frame: Up to 8 weeks from start of study

   The PROMIS Pediatric Anxiety is an 8-item measure of self-reported symptoms of anxiety symptoms in children and adolescents over the past 7 days. The measure has a 5-point rating scale (Never to Almost Always). Higher scores indicate greater symptoms.

6. Cancer-related worry

   Time frame: Up to 8 weeks from start of study

   The Fear of Cancer Recurrence Inventory is a 9-item measure developed specifically for survivors of childhood cancer (8-18 years) to assess the presence of fear of recurrence and perceived risk recurrence. The measure has 5-point rating scale (Not at All to A Great Deal). Higher scores indicate greater cancer-related worry. Internal consistency is good (ICC=0.88).

7. Physical functioning

   Time frame: Up to 8 weeks from start of study

   The PROMIS Pediatric Mobility is an 8-item measure of self-reported ability at physical activities in children and adolescents in the past 7 days. The measure has a 5-point rating scale (No Trouble to Not Able to Do). Higher scores indicate greater ability. It has excellent test-retest reliability (ICC=0.73) and adequate internal consistency (Cronbach's α=0.73-0.74). The PROMIS Pediatric Upper Extremity is an 8-item measure of self-upper extremity function in the past 7 days with higher score indicating greater ability. It has excellent test-retest reliability (ICC=0.71) and adequate internal consistency (Cronbach's α=0.62-0.63). Both measures are sensitive to change in participants with chronic pain.

8. Peer relations

   Time frame: Up to 8 weeks from start of study

   The PROMIS Pediatric Peer Relationship is an 8-item measure that assesses the quality of peer relationships. The measure has a 5-point rating scale (Never to Almost Always). Higher score indicating higher quality. It has excellent test-retest reliability (ICC=0.81) and excellent internal consistency (Cronbach's α=0.83-0.84).

9. Fatigue

   Time frame: Up to 8 weeks from start of study

   The PROMIS Pediatric Fatigue is a 10-item measure that assesses symptoms of fatigue in the past 7 days. The measure has a 5-point rating scale. Higher scores indicate more fatigue. It has excellent test-retest reliability (ICC=0.76) and internal consistency (Cronbach's α=0.87).

10. Sleep

    Time frame: Up to 8 weeks from start of study

    The Adolescent Sleep Wake Scale (ASWS) short form93 is a 10-item measure of behavioral sleep patterns in adolescents. The measure is a 6-point rating scale (Never to Always). Higher scores indicate better success of sleep quality. Internal consistency was good (α=0.74-0.84) in a pooled clinical sample of adolescents with mixed health conditions).93 Acceptable reliability was reported in a sample of ethnically diverse adolescents from an economically disadvantage community (α=0.70-0.90).94 We also will use the PROMIS Sleep-Related Impairment95 8-item measure to allow for assessment of sleep quality during the night as well as the impact of sleepiness on daytime function. This measure is validated for children and adolescents and assess sleep-related impairment over the past 7 days.

11. Opioid Use

    Time frame: Up to 8 weeks from start of study

    At each timepoint participants and/or their parents will be asked to list the names of their medications, doses taken, and the frequency with which the medications were taken over the past 2 weeks. Medications will be classified as anti-inflammatory (e.g., nonsteroidal anti-inflammatory drugs); regular (daily) opioids, opioid medication as required (PRN), adjuvant pain medications (e.g., anticonvulsants). Opioid doses will be converted to morphine equivalent doses (MED) using an opioid equivalence table.