Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Bone Sarcoma

Not Applicable

Completed

• Conditions: Bone Sarcoma
• Interventions: Behavioral: Cognitive Behavior Therapy; Other: Interview; Device: Transcranial Direct Current Stimulation; Drug: Placebo Administration; Other: Questionnaire Administration

• Registration Number: NCT05746429
• Lead Sponsor: St. Jude Children's Research Hospital

Brief Summary

This is a prospective study that will conduct a series of focus groups with non-Hispanic Black and Hispanic childhood cancer survivors to obtain their input on culturally adapting a mobile CBT program for chronic pain and tDCS procedures. Once this adaptation process is completed, the investigators will conduct a feasibility trial with non-Hispanic Black, Hispanic and non-Hispanic White childhood cancer survivors of bone sarcoma with chronic pain. The feasibility study will assign eligible participants to either culturally adapted mobile CBT + active tDCS to the dorsolateral prefrontal cortex or culturally adapted mobile CBT + sham tDCS. We anticipate approximately 60 participants for the focus groups and approximately 30 participants for the feasibility study for a total of about 90 participants.

Detailed Description

Survivors of pediatric bone sarcoma are at-risk for developing chronic pain. Cognitive behavioral therapy (CBT) is an effective non-pharmacologic treatment for chronic pain, and can be delivered remotely to reduce access barriers. However, these programs have not been adapted to be culturally sensitive to underserved populations thus limiting their reach, usefulness, and uptake. The investigators propose to culturally tailor an established, evidence-based mobile CBT program for chronic pain to Black and Hispanic adolescent survivors of childhood cancer. Once the program is fully adapted, we propose to pair the culturally adapted mobile CBT program with remotely delivered transcranial direct current stimulation (tDCS), which may enhance pain control in survivors. The investigators will conduct a 6-week feasibility study in a racially/ethnically diverse sample of non-Hispanic White, non-Hispanic Black, and Hispanic adolescent survivors of pediatric bone sarcoma with chronic pain using culturally adapted CBT paired with remote tDCS. Study results will inform the development of a randomized clinical trial.

Study Timeline

• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-02-27
• Study Start: 2023-04-06
• Primary Completion: 2024-10-29
• Study Completion: 2024-10-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (mobile CBT + sham tDCS)	Questionnaire Administration	Participants receive mobile CBT and undergo sham tDCS to the DLPFC over 20 minutes twice a week for 6 weeks.
Arm II (mobile CBT + sham tDCS)	Cognitive Behavior Therapy	Participants receive mobile CBT and undergo sham tDCS to the DLPFC over 20 minutes twice a week for 6 weeks.
Arm I (mobile CBT + active tDCS)	Cognitive Behavior Therapy	Participants receive mobile CBT and undergo active tDCS to the dorsolateral prefrontal cortex (DLPFC) over 20 minutes twice a week for 6 weeks.
Arm I (mobile CBT + active tDCS)	Questionnaire Administration	Participants receive mobile CBT and undergo active tDCS to the dorsolateral prefrontal cortex (DLPFC) over 20 minutes twice a week for 6 weeks.
Interview	Interview	Participants attend virtual meetings and virtual focus groups during the cultural adaptation phase. Feedback is collected and analyzed to develop the finalized adaptation.
Arm I (mobile CBT + active tDCS)	Transcranial Direct Current Stimulation	Participants receive mobile CBT and undergo active tDCS to the dorsolateral prefrontal cortex (DLPFC) over 20 minutes twice a week for 6 weeks.
Arm II (mobile CBT + sham tDCS)	Placebo Administration	Participants receive mobile CBT and undergo sham tDCS to the DLPFC over 20 minutes twice a week for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Fatigue	Up to 8 weeks from start of feasibility study	The PROMIS Pediatric Fatigue89 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).
Parental anxiety	Up to 8 weeks from start of feasibility study	Parental anxiety will be measured at each time point using the Generalized Anxiety Disorder 7-item (GAD-7), a measure of symptoms of generalized anxiety. The Generalized Anxiety Disorder measure is a 4-point rating scale (Not at All to Nearly Every Day). Higher scores indicate greater anxiety.
Pain intensity	Up to 8 weeks from start of feasibility 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).This will be used to inform placement of the anodal tDCS electrode (i.e., right vs. left DLPFC).
Pain interference	Up to 8 weeks from start of feasibility study	The Functional Disability Inventory (FDI)83 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	Up to 8 weeks from start of feasibility study	The Pain Catastrophizing Scale, Child version (PCS-C)85 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.86 This measure has good reliability (Cronbach's α=0.90) in a clinical sample of children and adolescents with chronic or recurrent pain.
Peer relations	Up to 8 weeks from start of feasibility study	The PROMIS Pediatric Peer Relationship92 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).
Opioid Use	Up to 8 weeks from start of feasibility study	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.98 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.
Parental depression	Up to 8 weeks from start of feasibility study	Parental depression will be measured at each time point using the Patient Health Questionnaire 8-item (PHQ-8), a measure of symptoms of major depressive disorder101. The Patient Health Questionnaire is a 4-point rating scale (Not at All to Nearly Every Day) Higher scores indicate greater depression.
Depression	Up to 8 weeks from start of feasibility study	The PROMIS Pediatric Depressive Symptoms87 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	Up to 8 weeks from start of feasibility study	The PROMIS Pediatric Anxiety87 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	Up to 8 weeks from start of feasibility study	The Fear of Cancer Recurrence Inventory88 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).
Physical functioning	Up to 8 weeks from start of feasibility study	The PROMIS Pediatric Mobility89 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).90 The PROMIS Pediatric Upper Extremity89 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).90 Both measures are sensitive to change in participants with chronic pain.
Sleep	Up to 8 weeks from start of feasibility study	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.
Global acceptability and satisfaction with treatment	Up to 8 weeks from start of feasibility study	Acceptability and satisfaction with treatment will be assessed using a 5-point numerical rating scale (NRS) (strongly disagree to strongly agree). Higher score indicates greater satisfaction. The numerical rating scale has been recommended for use in pediatric pain clinical trials.96 Two adapted questions from the modified treatment evaluation inventory will be utilized.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States