NCT07160621 Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial
| NCT ID | NCT07160621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Childhood Cancer Survivor |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2025-09-05 |
| Primary Completion | 2028-02 |
Trial Parameters
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Brief Summary
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
Inclusion Criteria: * 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 * Pain interfering with at least one area of daily functioning * Parent/Caregiver Participants * ≥ 18 years of age * Legally authorized to provide informed consent for the adolescent participant Exclusion Criteria: * 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 * Note: A participant who completed the feasibility study (ADAPTED) cannot participate in the subsequent clinical trial (ADAPTED2) * Parent/Caregiver Participants * Not fluent in English or Spanish * Unable to provide consent for own participation or for the participation of the adolescent participant
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