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

Обзор

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.

Подробное описание

Survivors of childhood cancer with lasting pain may have problems with daily life, such as paying attention, sleeping, or daily activities. A mobile cognitive behavioral therapy program (App) and patient education materials may be helpful for survivors with pain. Researchers at St. Jude Children's Research Hospital want to see if these tools can used to improve pain in survivors. Participants will be recruited from 4 sites: St. Jude Children's Research Hospital (SJCRH), Children's Healthcare of Atlanta (CHOA), Texas Children's Hospital (TCH), and Seattle Children's Hospital (SCH).

Standard treatment for pain that continues after cancer and its treatment may include pain education, medication and/or cognitive behavioral therapy. Cognitive behavioral therapy (CBT) is a treatment that focuses on helping people change how they think and feel about pain. This treatment is often delivered in person.

Participants will be asked to either use a mobile CBT program or review educational materials about pain for 6 weeks. For those using the CBT program, the program can be accessed at their convenience through an App on their phone and they will be asked to use the App at least 2 to 3 days per week.

Primary Objective:

To conduct a randomized clinical trial to determine the efficacy of adapted mobile CBT vs. patient education to improve pain intensity and functional disability post-intervention in a racially/ethnically and geographically diverse sample of adolescent survivors of childhood cancer with chronic pain.

Secondary Objective:

To investigate longitudinal associations between patient-reported comorbidities including symptoms of depression, anxiety, sleep quality, fatigue, physical functioning, and pain medication use with changes in pain intensity and functional disability.

Вмешательства

• Поведенческое Cognitive Behavioral Therapy (CBT)
  Receive mobile CBT
• Поведенческое Education
  Receive educational materials
• Другое Questionnaires
  Ancillary studies

Первичные конечные точки

• Pain intensity [Срок оценки: Up to 8 weeks from start of study]
• Pain interference [Срок оценки: Up to 8 weeks from start of study]
• Pain catastrophizing [Срок оценки: Up to 8 weeks from start of study]
• Depression [Срок оценки: Up to 8 weeks from start of study]
• Anxiety [Срок оценки: Up to 8 weeks from start of study]
• Cancer-related worry [Срок оценки: Up to 8 weeks from start of study]
• Physical functioning [Срок оценки: Up to 8 weeks from start of study]
• Peer relations [Срок оценки: Up to 8 weeks from start of study]
• Fatigue [Срок оценки: Up to 8 weeks from start of study]
• Sleep [Срок оценки: Up to 8 weeks from start of study]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• St. Jude Children's Research Hospital — Memphis

Идентификаторы

NCT: NCT07160621 · ADAPTED2 · NCI-2025-06050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗