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

Study Overview
=================
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.

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

Conditions
-----------------
Bone Sarcoma

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavior Therapy
* Device: Transcranial Direct Current Stimulation
* Other: Interview
* Drug: Placebo Administration
* Other: Questionnaire Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for focus groups Adults Hispanic or non-Hispanic Black childhood cancer survivor or parent of Hispanic or non-Hispanic childhood cancer survivor 18 years or older Adolescents 10-17 year-old survivors of childhood cancer At least one year post treatment Hispanic or non- Hispanic Black Exclusion Criteria for focus groups • Adults/Adolescents o Inability or unwillingness of research participant 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 bone sarcoma 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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (mobile CBT + active tDCS)<br>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<br>* Receive mobile CBT<br>* Other names: CBT, CBT, cognitive behavior therapy, cognitive therapy, CT;Device: Transcranial Direct Current Stimulation<br>* Undergo active tDCS<br>* Other names: tDCS;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Sham Comparator: Arm II (mobile CBT + sham tDCS)<br>Participants receive mobile CBT and undergo sham tDCS to the DLPFC over 20 minutes twice a week for 6 weeks. | Behavioral: Cognitive Behavior Therapy<br>* Receive mobile CBT<br>* Other names: CBT, CBT, cognitive behavior therapy, cognitive therapy, CT;Drug: Placebo Administration<br>* Undergo sham tDCS<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: Interview<br>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<br>* Attend virtual meetings and focus groups<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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).This will be used to inform placement of the anodal tDCS electrode (i.e., right vs. left DLPFC). | Up to 8 weeks from start of feasibility study | 
| Pain interference | 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). | Up to 8 weeks from start of feasibility study | 
| Pain catastrophizing | 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. | Up to 8 weeks from start of feasibility study | 
| Depression | 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. | Up to 8 weeks from start of feasibility study | 
| Anxiety | 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. | Up to 8 weeks from start of feasibility study | 
| Cancer-related worry | 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). | Up to 8 weeks from start of feasibility study | 
| Physical functioning | 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. | Up to 8 weeks from start of feasibility study | 
| Peer relations | 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). | Up to 8 weeks from start of feasibility study | 
| Fatigue | 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). | Up to 8 weeks from start of feasibility 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 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 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. | 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.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. | 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 disorder101. The Patient Health Questionnaire is a 4-point rating scale (Not at All to Nearly Every Day) Higher scores indicate greater depression. | 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 (Not at All to Nearly Every Day). Higher scores indicate greater anxiety. | Up to 8 weeks from start of feasibility study |