Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial
ID: NCT07160621
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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.
Read Full Scientific Objectives & Methods
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.
Receive mobile CBT
Receive educational materials
Ancillary studies
Treatment Arms Description
Participants who are randomized to receive mobile CBT for chronic pain.
Participants who are randomized to receive educational materials about chronic pain.
- 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
- 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
Primary Outcome Measures
- Pain intensity — Time Frame: Up to 8 weeks from start of study
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).
- Pain interference — Time Frame: Up to 8 weeks from start of study
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).
- Pain catastrophizing — Time Frame: Up to 8 weeks from start of study
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.
- Depression — Time Frame: Up to 8 weeks from start of study
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.
- Anxiety — Time Frame: Up to 8 weeks from start of study
The PROMIS Pediatric Anxiety is an 8-item measure of self-reported symptoms of anxiety symptoms in children and adolescents over the past 7 days. The measure has a 5-point rating scale (Never to Almost Always). Higher scores indicate greater symptoms.
- Cancer-related worry — Time Frame: Up to 8 weeks from start of study
The Fear of Cancer Recurrence Inventory is a 9-item measure developed specifically for survivors of childhood cancer (8-18 years) to assess the presence of fear of recurrence and perceived risk recurrence. The measure has 5-point rating scale (Not at All to A Great Deal). Higher scores indicate greater cancer-related worry. Internal consistency is good (ICC=0.88).
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial