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

NCT07160621 | Recruiting

• 2 other identifiers: ADAPTED2NCI-2025-06050
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Cancer Survivor; Chronic Pain

Keywords

Adult Caregiver; Adolescent Survivor

Outcome Measures

Primary Outcomes (11)

• Pain intensity

  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).

  Up to 8 weeks from start of study

• Pain interference

  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).

  Up to 8 weeks from start of study

• Pain catastrophizing

  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.

  Up to 8 weeks from start of study

• Depression

  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.

  Up to 8 weeks from start of study

• Anxiety

  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.

  Up to 8 weeks from start of study

• Cancer-related worry

  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).

  Up to 8 weeks from start of study

• Physical functioning

  The PROMIS Pediatric Mobility is an 8-item measure of self-reported ability at physical activities in children and adolescents in the past 7 days. The measure has a 5-point rating scale (No Trouble to Not Able to Do). Higher scores indicate greater ability. It has excellent test-retest reliability (ICC=0.73) and adequate internal consistency (Cronbach's α=0.73-0.74). The PROMIS Pediatric Upper Extremity is an 8-item measure of self-upper extremity function in the past 7 days with higher score indicating greater ability. It has excellent test-retest reliability (ICC=0.71) and adequate internal consistency (Cronbach's α=0.62-0.63). Both measures are sensitive to change in participants with chronic pain.

  Up to 8 weeks from start of study

• Peer relations

  The PROMIS Pediatric Peer Relationship is an 8-item measure that assesses the quality of peer relationships. The measure has a 5-point rating scale (Never to Almost Always). Higher score indicating higher quality. It has excellent test-retest reliability (ICC=0.81) and excellent internal consistency (Cronbach's α=0.83-0.84).

  Up to 8 weeks from start of study

• Fatigue

  The PROMIS Pediatric Fatigue is a 10-item measure that assesses symptoms of fatigue in the past 7 days. The measure has a 5-point rating scale. Higher scores indicate more fatigue. It has excellent test-retest reliability (ICC=0.76) and internal consistency (Cronbach's α=0.87).

  Up to 8 weeks from start of study

• Sleep

  The Adolescent Sleep Wake Scale (ASWS) short form93 is a 10-item measure of behavioral sleep patterns in adolescents. The measure is a 6-point rating scale (Never to Always). Higher scores indicate better success of sleep quality. Internal consistency was good (α=0.74-0.84) in a pooled clinical sample of adolescents with mixed health conditions).93 Acceptable reliability was reported in a sample of ethnically diverse adolescents from an economically disadvantage community (α=0.70-0.90).94 We also will use the PROMIS Sleep-Related Impairment95 8-item measure to allow for assessment of sleep quality during the night as well as the impact of sleepiness on daytime function. This measure is validated for children and adolescents and assess sleep-related impairment over the past 7 days.

  Up to 8 weeks from start of study

• Opioid Use

  At each timepoint participants and/or their parents will be asked to list the names of their medications, doses taken, and the frequency with which the medications were taken over the past 2 weeks. Medications will be classified as anti-inflammatory (e.g., nonsteroidal anti-inflammatory drugs); regular (daily) opioids, opioid medication as required (PRN), adjuvant pain medications (e.g., anticonvulsants). Opioid doses will be converted to morphine equivalent doses (MED) using an opioid equivalence table.

  Up to 8 weeks from start of study

Study Arms (2)

Arm I (mobile CBT)

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy (CBT); Other: Questionnaires

Arm II (Patient education)

SHAM COMPARATOR

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

Behavioral: Education; Other: Questionnaires

Interventions

Questionnaires OTHER

Ancillary studies

Arm I (mobile CBT); Arm II (Patient education)

Education BEHAVIORAL

Receive educational materials

Also known as: Psychoeducation; patient education

Arm II (Patient education)

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Receive mobile CBT

Also known as: CBT, CBT, cognitive behavior therapy, cognitive therapy, CT

Arm I (mobile CBT)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescent Participants
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy; Educational Status; Patient Education as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tara Brinkman, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Brinkman, PhD

CONTACT

888-226-4343; referralinfo@stjude.org

Tara Brinkman

CONTACT

8662785833; referralinfo@stjude.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)