Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer: A Randomized Clinical Trial
NCT ID: NCT07160621
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
204 participants
INTERVENTIONAL
2025-09-05
2029-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (mobile CBT)
Participants who are randomized to receive mobile CBT for chronic pain.
Cognitive Behavioral Therapy (CBT)
Receive mobile CBT
Questionnaires
Ancillary studies
Arm II (Patient education)
Participants who are randomized to receive educational materials about chronic pain.
Education
Receive educational materials
Questionnaires
Ancillary studies
Interventions
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Cognitive Behavioral Therapy (CBT)
Receive mobile CBT
Education
Receive educational materials
Questionnaires
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
17 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Tara Brinkman, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2025-06050
Identifier Type: OTHER
Identifier Source: secondary_id
ADAPTED2
Identifier Type: -
Identifier Source: org_study_id
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