Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy (CBT), Education, Questionnaires.
- Who it may be relevant to
- Registry conditions: Childhood Cancer Survivor, Chronic Pain. Basic parameters: 10 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Behavioral Cognitive Behavioral Therapy (CBT)
Receive mobile CBT - Behavioral Education
Receive educational materials - Other Questionnaires
Ancillary studies
Primary outcome measures
- Pain intensity [Time frame: Up to 8 weeks from start of study]
- Pain interference [Time frame: Up to 8 weeks from start of study]
- Pain catastrophizing [Time frame: Up to 8 weeks from start of study]
- Depression [Time frame: Up to 8 weeks from start of study]
- Anxiety [Time frame: Up to 8 weeks from start of study]
- Cancer-related worry [Time frame: Up to 8 weeks from start of study]
- Physical functioning [Time frame: Up to 8 weeks from start of study]
- Peer relations [Time frame: Up to 8 weeks from start of study]
- Fatigue [Time frame: Up to 8 weeks from start of study]
- Sleep [Time frame: Up to 8 weeks from start of study]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- St. Jude Children's Research Hospital — Memphis
Identifiers
NCT: NCT07160621 · ADAPTED2 · NCI-2025-06050