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

NCT05746429 | Completed Results DMC FDA Device

• 3 other identifiers: ADAPTEDNCI-2022-10013R61CA280978
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bone Sarcoma; Childhood Cancer

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (3)

Arm I (mobile CBT + active tDCS)

EXPERIMENTAL

Participants receive mobile CBT and undergo active tDCS to the dorsolateral prefrontal cortex (DLPFC) over 20 minutes twice a week for 6 weeks.

Behavioral: Cognitive Behavior Therapy; Device: Transcranial Direct Current Stimulation; Other: Questionnaire Administration

Arm II (mobile CBT + sham tDCS)

SHAM COMPARATOR

Participants receive mobile CBT and undergo sham tDCS to the DLPFC over 20 minutes twice a week for 6 weeks.

Behavioral: Cognitive Behavior Therapy; Drug: Placebo Administration; Other: Questionnaire Administration

Interview

EXPERIMENTAL

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

Interventions

Cognitive Behavior Therapy BEHAVIORAL

Receive mobile CBT

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

Arm I (mobile CBT + active tDCS); Arm II (mobile CBT + sham tDCS)

Placebo Administration DRUG

Undergo sham tDCS

Arm II (mobile CBT + sham tDCS)

Transcranial Direct Current Stimulation DEVICE

Undergo active tDCS

Also known as: tDCS

Arm I (mobile CBT + active tDCS)

Questionnaire Administration OTHER

Ancillary studies

Arm I (mobile CBT + active tDCS); Arm II (mobile CBT + sham tDCS)

Interview OTHER

Attend virtual meetings and focus groups

Interview

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Bone Neoplasms; Neoplasms

Interventions

Cognitive Behavioral Therapy; Transcranial Direct Current Stimulation; Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; 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

Results Point of Contact

• Title: Tara Brinkman, PhD
• Organization: St. Jude Children's Research Hospital

info@stjude.org

1-866-278-5833

Study Officials

• Tara Brinkman, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 27, 2023
• Study Start: April 6, 2023
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-02

Locations

US (1)