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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-17
SponsorSt. Jude Children's Research Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Cognitive Behavioral Therapy (CBT)

    Behavioral

    Receive mobile CBT

  • Education

    Behavioral

    Receive educational materials

  • Questionnaires

    Other intervention

    Ancillary studies

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Arm I (mobile CBT)Experimental treatment 2 interventions
Group B: Arm II (Patient education)Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 8 weeks from start of study
2

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).

Time frame
Up to 8 weeks from start of study
3

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.

Time frame
Up to 8 weeks from start of study
4

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.

Time frame
Up to 8 weeks from start of study

Secondary outcomes

Other outcomes

Sponsors and contacts

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