Mobile CBT for Chronic Pain in Childhood Cancer Survivors

(ADAPTED2 Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Psychiatric condition, Substance abuse, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app offering cognitive behavioral therapy (CBT) can more effectively reduce chronic pain and improve daily life for adolescent survivors of childhood cancer than standard pain education. Participants are randomly assigned to either use the CBT app or receive educational materials about chronic pain. Suitable candidates for this trial are teenagers who have survived childhood cancer, completed treatment over a year ago, and have experienced persistent pain affecting their daily activities for at least three months. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could lead to new pain management solutions.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mobile CBT app is safe for adolescent survivors of pediatric cancer?

Research shows that using mobile apps for cognitive behavioral therapy (CBT) to treat chronic pain is generally safe. Previous studies have found that traditional CBT is well-tolerated by most people. Delivered through a mobile app, this therapy focuses on teaching skills to manage pain, avoiding the risks associated with medication or surgery.

CBT has a strong safety record because it involves talking and learning new coping strategies, rather than physical treatments or drugs. Significant problems with mobile CBT have not been reported, making it a low-risk option for managing pain. This is reassuring for those considering joining the trial, as it suggests the treatment is likely safe and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mobile CBT for chronic pain in adolescent cancer survivors because it offers a culturally adapted, accessible way to manage pain outside of traditional settings. Unlike standard treatments that might involve medication or in-person therapy, this approach leverages technology to deliver cognitive behavioral therapy directly to the user's smartphone, making it potentially more convenient and engaging for young people. Additionally, the incorporation of cultural adaptations aims to make the therapy more relatable and effective for diverse populations, potentially increasing its overall impact.

What evidence suggests that this trial's treatments could be effective for chronic pain in adolescent cancer survivors?

Research has shown that cognitive behavioral therapy (CBT) can help reduce long-term pain. In this trial, participants will be randomized into different treatment arms. One arm will receive mobile CBT, specially designed for teenagers who have survived childhood cancer. This approach has shown promise in helping them feel better and experience less pain. Studies indicate that about one in four childhood cancer survivors experience ongoing pain after their treatment ends. CBT, especially when available through a mobile app, offers an easy-to-access, non-drug option. These findings suggest that mobile CBT might help manage pain and improve the quality of life for young cancer survivors. ^{1 2 3 4 5}

Who Is on the Research Team?

Tara Brinkman, PhD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for adolescent survivors of pediatric cancer who are experiencing chronic pain. Participants will include 102 adolescents and their caregivers, totaling 204 individuals across four U.S. hospitals. To join, they must be dealing with ongoing pain after surviving childhood cancer.

Inclusion Criteria

I am a teen cancer survivor aged 10-17.

I am a teenager and have had pain for over 3 months that affects my daily activities.

I am over 18 and can legally consent for a minor in a clinical trial.

Exclusion Criteria

Adolescent Participants with current substance abuse as determined by the Substance Use Screening Questionnaire

Parent/Caregiver Participants who are unable to provide consent for their own participation or for the participation of the adolescent participant

Adolescent Participants who completed the feasibility study (ADAPTED) cannot participate in the subsequent clinical trial (ADAPTED2)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants will use a mobile CBT program or review educational materials about pain for 6 weeks

6 weeks

Participants use the app at least 2 to 3 days per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Cancer

Trial Overview The study tests a mobile app delivering cognitive behavioral therapy (CBT) adapted for these survivors, comparing it to standard pain education. The goal is to see if the app can better reduce pain and improve daily life. Assessments will be made at the start, after treatment, and three months later.

How Is the Trial Designed?

Group I: Arm I (mobile CBT) Experimental Treatment 2 Interventions

Participants who are randomized to receive mobile CBT for chronic pain.

Group II: Arm II (Patient education) Placebo Group 2 Interventions

Participants who are randomized to receive educational materials about chronic pain.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07160621

Culturally Adapted Mobile Treatment of Chronic Pain in ... Outcomes include pain reduction, improved function, and the role of social determinants of health. Assessments occur at baseline, post-treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10427928/

Internet-Delivered Cognitive Behavioral Treatment for ... Our previous work demonstrated that approximately 1 in 4 survivors of childhood cancer experiences chronic pain after treatment completion and 1 in 5 ...

3. trialx.com trialx.com/clinical-trials/listings/322346/culturally-adapted-mobile-treatment-of-chronic-pain-in-adolescent-survivors-of-pediatric-cancer-a-randomized-clinical-trial/?&radius=10&place=a&user_country=a%20N

Culturally Adapted Mobile Treatment of Chronic Pain in ... Outcomes include pain reduction, improved function, and the role of social determinants of health. Assessments occur at baseline, post-treatment ...

4. withpower.com withpower.com/trial/phase-chronic-pain-8-2025-d0e54

Mobile CBT for Chronic Pain in Childhood Cancer Survivors Trial Overview The study tests a mobile app delivering cognitive behavioral therapy (CBT) adapted for these survivors, comparing it to standard pain education.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05746429

Culturally Adapted Mobile Treatment of Chronic Pain in ... Survivors of pediatric bone sarcoma are at-risk for developing chronic pain. Cognitive behavioral therapy (CBT) is an effective non-pharmacologic treatment for ...