Bone Sarcoma, Childhood Cancer
Conditions
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.
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.
Interventions
BEHAVIORALCognitive Behavior Therapy
Receive mobile CBT
DEVICETranscranial Direct Current Stimulation
Undergo active tDCS
DRUGPlacebo Administration
Undergo sham tDCS
OTHERQuestionnaire Administration
Ancillary studies
OTHERInterview
Attend virtual meetings and focus groups
Sponsors
St. Jude Children's Research Hospital
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Pain Interference | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Pain Catastrophizing | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Parental Anxiety | Baseline (enrollment) and 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 (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. |
| Depression | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Anxiety | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Cancer-related Worry | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Physical Functioning | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Peer Relations | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Fatigue | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Sleep (Adolescent Sleep Wake Scale (ASWS)) | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| Sleep (PROMIS Sleep-related Impairment) | Baseline (enrollment) and up to 8 weeks from start of feasibility study | 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. |
| 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 acceptability and satisfaction. The answers were categorized as agree yes (strongly agree or agree) versus no (neither agree nor disagree, disagree, or strongly disagree). |
| Opioid Use | Baseline (enrollment) and 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. 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 |
| Parental Depression | Baseline (enrollment) and 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 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTara Brinkman, PhD
St. Jude Children's Research Hospital
Participant flow
Recruitment details
From April 2023 to August 2024, 68 participants were enrolled across two phases. Phase 1, a cultural adaptation study, included 38 participants in qualitative focus groups. Phase 2, a feasibility clinical trial with two arms, enrolled 33 participants. Three adolescents participated in both phases.
Pre-assignment details
In the cultural adaptation phase, participants took part in focus groups and did not receive any intervention. In the feasibility study, all participants received the adapted mobile CBT. Participants were also assigned to active or sham transcranial direct current stimulation (tDCS) using an ABAB design within racial/ethnic groups (Hispanic, non-Hispanic Black, non-Hispanic White).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 13.17 years STANDARD_DEVIATION 2.18 |
| Race/Ethnicity, Customized Black or African American | 30 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 5 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 6 Participants |
| Region of Enrollment United States | 68 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 38 | 14 / 14 | 15 / 16 |
| serious Total, serious adverse events | 0 / 38 | 0 / 14 | 0 / 16 |
Outcome results
None listed