Culturally adapted mobile cognitive behavioral therapy for chronic pain in adolescent survivors of childhood cancer

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

This trial tests whether a culturally adapted mobile cognitive behavioral therapy app can help adolescent survivors of childhood cancer reduce chronic pain and improve daily life, with a caregiver taking part too.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 10 Years to 17 Years
• Sex: All
• Sponsor: St. Jude Children's Research Hospital (other)
• Locations: 1 site (Memphis, Tennessee)
• Trial ID: NCT07160621 on ClinicalTrials.gov

What this trial studies

This randomized study will enroll 228 participants (114 adolescent survivors aged 10–17 plus 114 caregivers) across four U.S. pediatric centers and randomize adolescents to use an adapted mobile CBT app or to receive standard pain education for six weeks. The app is designed for at-home use with a recommended 2–3 sessions per week, while outcomes are measured at baseline, post-treatment, and three-month follow-up. Primary outcomes include pain intensity and functional disability, and analyses will consider the influence of social determinants of health. Participants are screened for eligibility including pain duration (≥3 months), being ≥1 year off cancer treatment, and exclusion of serious psychiatric or cognitive conditions.

Who should consider this trial

Good fit: Ideal candidates are 10–17-year-old survivors of childhood cancer who are at least one year off treatment, have pain for three months or longer that interferes with daily life, and have a consenting caregiver aged 18 or older.

Not a fit: Patients with serious psychiatric illness, current substance abuse, significant cognitive impairment or developmental delay, or caregivers not fluent in English or Spanish are unlikely to benefit from or be eligible for this program.

Why it matters

Potential benefit: If successful, the app could reduce chronic pain and improve daily functioning for adolescent cancer survivors while offering a convenient, culturally tailored option families can use at home.

How similar studies have performed: Mobile CBT programs for pediatric chronic pain have shown promise in prior work and a feasibility ADAPTED study informed this trial, but large randomized trials specifically in adolescent cancer survivors remain limited.

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

Where this trial is running

Memphis, Tennessee

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States (RECRUITING)

Study contacts

• Principal investigator: Tara Brinkman, PhD — St. Jude Children's Research Hospital
• Study coordinator: Tara Brinkman, PhD

Conditions: Childhood Cancer Survivor, Chronic Pain, Adult Caregiver, Adolescent Survivor