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

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

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 survivors of childhood cancer 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.

Study Overview

• Status: Completed
• Conditions: Childhood Cancer; Bone Sarcoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Cognitive Behavior Therapy; Device: Transcranial Direct Current Stimulation; Drug: Placebo Administration; Other: Interview

Detailed Description

Survivors of pediatric childhood cancer 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 childhood cance with chronic pain using culturally adapted CBT paired with remote tDCS. Study results will inform the development of a randomized clinical trial.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusions Criteria for cultural adaption

• Adult
• Hispanic or non-Hispanic Black childhood cancer survivor or parent of Hispanic or non-Hispanic Black childhood cancer survivor
• 18 years or older
• Adolescents
• 10-17 years-old survivors of childhood cancer
• At least one year post treatment
• Hispanic or non-Hispanic Black
• Phase 4 only: History of chronic pain (i.e. pain that was present for more than 3 months)

Exclusion Criteria for cultural adaptation

• Adults/Adolescents
• Inability or unwillingness of research participants or legal guardian/representative to give written informed consent

Inclusion Criteria for feasibility study

• Hispanic, non-Hispanic Black and non-Hispanic White 10-17-year-old survivors of pediatric cancer
• At least one year post treatment
• Pain present over the past 3 months and pain at least once per week
• Pain interfering with at least one area of daily functioning

Exclusion Criteria for feasibility study

• Limb amputation
• History of seizures or other neurological disorders
• Implanted medical device or metal in the head
• Serious comorbid psychiatric condition
• Current substance abuse
• History of development delay or significant cognitive impairment
• History of brain tumor diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (mobile CBT + active tDCS); Participants receive mobile CBT and undergo active tDCS to the dorsolateral prefrontal cortex (DLPFC) over 20 minutes twice a week for 6 weeks.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Cognitive Behavior Therapy; Receive mobile CBT; Other Names: CBT, CBT, cognitive behavior therapy, cognitive therapy, CT; Device: Transcranial Direct Current Stimulation; Undergo active tDCS; Other Names: tDCS
Sham Comparator: Arm II (mobile CBT + sham tDCS); Participants receive mobile CBT and undergo sham tDCS to the DLPFC over 20 minutes twice a week for 6 weeks.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Cognitive Behavior Therapy; Receive mobile CBT; Other Names: CBT, CBT, cognitive behavior therapy, cognitive therapy, CT; Drug: Placebo Administration; Undergo sham tDCS
Experimental: Interview; Participants attend virtual meetings and virtual focus groups during the cultural adaptation phase. Feedback is collected and analyzed to develop the finalized adaptation.	Other: Interview; Attend virtual meetings and focus groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Efficacy of mobile CBT paired with active versus sham tDCS on pain intensity in adolescent survivors with chronic pain. 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 using a 10-point rating scale (0=no pain to 10=pain as bad as you can imagine). The pain severity score was calculated as the average of the 4 items, with scores ranging between 0 and 10. Higher scores indicate greater pain intensity. Changes in pain intensity from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Pain Interference	Efficacy of mobile CBT paired with active versus sham tDCS on pain interference in adolescent survivors with chronic pain. Using the BPI, participants rate the impact of pain on general activity, mood, walking ability, normal work/school, relationships with other people, sleep and enjoyment of life using a 10-point rating scale (0=does not interfere to 10=completely interferes). The pain interference score was calculated as the average of the 7 items, with scores ranging between 0 and 10. Higher scores indicate greater pain interference. Changes in pain interference from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Pain Catastrophizing	The Pain Catastrophizing Scale, Child version (PCS-C) is a 13-item self-report measure of overly negative attitudes of pain. It consists of three scales of rumination, magnification and helplessness. The measure uses a 5-point rating scale (0=not at all true to 4=very true). The scores of three subscales were calculated as the sum of specific items: Rumination (4 items; score range 0-16), Magnification (3 items; score range 0-12), and Helplessness (6 items; score range 0-24). The total score was calculated as the sum of all 13 items (score range 0-52). Higher scores indicate worse outcomes (i.e., more pain rumination, magnification, helplessness and overall pain catastrophizing). Changes in pain catastrophizing from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Depression	The Patient-Reported Outcomes Measurement Information (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 Always). The PROMIS Health Measures Scoring Service was used to convert raw scores to T-scores (population mean=50 and standard deviation=10. Higher scores indicate more severe depressive symptoms. Changes in depressive symptoms from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Anxiety	The Patient-Reported Outcomes Measurement Information System (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). The PROMIS Health Measures Scoring Service was used to convert raw scores to T-scores (population mean=50 and standard deviation=10). Higher scores indicate more severe anxiety symptoms. Changes in anxiety symptoms from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility 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 (0=Not at All to 4=A Great Deal). The total score was calculated as the sum of all 9 items, with scores ranging between 0 and 36. Higher scores indicate greater cancer-related worry. Changes in cancer-related worry symptoms from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Physical Functioning	The Patient-Reported Outcomes Measurement Information System (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 PROMIS Pediatric Upper Extremity is an 8-item measure of self-upper extremity function in the past 7 days. Both measures have a 5-point rating scale (No Trouble to Not Able to Do). For both measures, the PROMIS Health Measures Scoring Service was used to convert raw scores to T-scores (population mean=50 and standard deviation=10). Higher scores indicate better outcomes (i.e., greater mobility and upper extremity function, respectively). Changes in physical functioning from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Peer Relations	The Patient-Reported Outcomes Measurement Information System (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). The PROMIS Health Measures Scoring Service was used to convert raw scores to T-scores (population mean=50 and standard deviation=10). Higher scores indicate better quality relationships with peers. Changes in peer relationship quality from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Fatigue	The Patient-Reported Outcomes Measurement Information System (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 (Never to Almost Always). The PROMIS Health Measures Scoring Service was used to convert raw scores to T-scores (population mean=50 and standard deviation=10). Higher scores indicate more fatigue. Changes in fatigue from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Sleep (Adolescent Sleep Wake Scale (ASWS))	The Adolescent Sleep Wake Scale (ASWS) short form is a 10-item measure of behavioral sleep patterns in adolescents. The measure has a 6-point rating scale (1=Never to 6=Always). The total score was calculated as the average of the 10 items, with scores ranging between 0 and 6. Higher scores indicating better success of sleep quality. Changes in sleep from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Sleep (PROMIS Sleep-related Impairment)	The Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment 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 assesses sleep-related impairment over the past 7 days. The measure has a 5-point rating scale (Never to Always). The PROMIS Health Measures Scoring Service was used to convert raw scores to T-scores (population mean=50 and standard deviation=10). Higher scores indicate more sleep problems. Changes in sleep from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Global Acceptability and Satisfaction With Treatment	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 acceptability and satisfaction. The answers were categorized as agree yes (strongly agree or agree) versus no (neither agree nor disagree, disagree, or strongly disagree).	Up to 8 weeks from start of feasibility 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. Opioid doses will be converted to morphine equivalent doses (MED; in mg) using an opioid equivalence table. Changes in opioid use from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported. Note: no participants reported taking opioids during the study	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Parental Depression	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 disorder. The Patient Health Questionnaire is a 4-point rating scale (0=Not at All to 3=Nearly Every Day). The total score was calculated as the sum of all 8 items, with scores ranging between 0 and 24. Higher scores indicate greater depression. . Changes in parental depression from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study
Parental Anxiety	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 (0=Not at 3=All to Nearly Every Day). The total score was calculated as the sum of all 7 items, with scores ranging between 0 and 21. Higher scores indicate greater anxiety. Changes in parental anxiety from baseline (enrollment) up to 8 weeks from the start of the intervention in the active treatment and placebo groups were reported.	Baseline (enrollment) and up to 8 weeks from start of feasibility study

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Tara Brinkman, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Actual): October 29, 2024
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Bone Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Interviews as Topic; Cognitive Behavioral Therapy; Transcranial Direct Current Stimulation
• Other Study ID Numbers: ADAPTED; NCI-2022-10013 (Other Identifier: NCI Clinical Trial Registration Program); R61CA280978 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes