About this trial
The purpose of the study is to determine if an adapted mobile cognitive behavioral therapy (CBT) app (WebMAP Onc) is more effective than standard pain education in reducing chronic pain and improving daily functioning in adolescent survivors of pediatric cancer.
This randomized study led by St. Jude Children's Research Hospital will involve 228 participants (114 adolescent survivors and 114 caregivers) across four U.S. hospitals. Outcomes include pain reduction, improved function, and the role of social determinants of health. Assessments occur at baseline, post-treatment, and 3-month follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescent Participants
10-17-year-old survivors of childhood cancer or those who received cancer directed therapies (e.g., Langerhan's Histiocytosis)
At least one-year post treatment completion
Pain present for 3 months or longer
Disqualifiers
Adolescent Participants
Serious comorbid psychiatric condition
Current substance abuse as determined by the Substance Use Screening Questionnaire
History of development delay or significant cognitive impairment
Trial design
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy (CBT)
BehavioralReceive mobile CBT
Education
BehavioralReceive educational materials
Questionnaires
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Pain intensity
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).
Pain interference
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).
Pain catastrophizing
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.
Depression
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.
Sponsors and contacts
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