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Trial Title:
Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Bone Sarcoma
NCT ID:
NCT05746429
Condition:
Bone Sarcoma
Conditions: Official terms:
Sarcoma
Osteosarcoma
Chronic Pain
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cognitive Behavior Therapy
Description:
Receive mobile CBT
Arm group label:
Arm I (mobile CBT + active tDCS)
Arm group label:
Arm II (mobile CBT + sham tDCS)
Other name:
CBT, CBT, cognitive behavior therapy, cognitive therapy, CT
Intervention type:
Device
Intervention name:
Transcranial Direct Current Stimulation
Description:
Undergo active tDCS
Arm group label:
Arm I (mobile CBT + active tDCS)
Other name:
tDCS
Intervention type:
Other
Intervention name:
Interview
Description:
Attend virtual meetings and focus groups
Arm group label:
Interview
Intervention type:
Drug
Intervention name:
Placebo Administration
Description:
Undergo sham tDCS
Arm group label:
Arm II (mobile CBT + sham tDCS)
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (mobile CBT + active tDCS)
Arm group label:
Arm II (mobile CBT + sham tDCS)
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.
Criteria for 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
- Phase 4 only: History of chronic pain
- Pain that was present for more than 3 months
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
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
Gender:
All
Minimum age:
10 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tara Brinkman, PhD
Phone:
866-278-5833
Email:
referralinfo@stjude.org
Start date:
April 6, 2023
Completion date:
October 2025
Lead sponsor:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
St. Jude Children's Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746429
