Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial (ADAPTED2)
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Details and patient eligibility
About
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 204 participants (102 adolescent survivors and 102 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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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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
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Parent/Caregiver Participants
- ≥ 18 years of age
- Legally authorized to provide informed consent for the adolescent participant
Exclusion criteria
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Adolescent Participants
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Serious comorbid psychiatric condition
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Current substance abuse as determined by the Substance Use Screening Questionnaire
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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)
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Parent/Caregiver Participants
- Not fluent in English or Spanish
- Unable to provide consent for own participation or for the participation of the adolescent participant
Trial design
Primary purpose
Allocation
Interventional model
Masking
204 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Tara Brinkman, PhD; Tara Brinkman
Data sourced from clinicaltrials.gov
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