Clinical trial NCT05746429: Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Bone Sarcoma
Official title: Culturally Adapted Mobile Treatment of Chronic Pain in Adolescent Survivors of Pediatric Bone Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Sarcoma
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2023-02-27
Enrollment: 68
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: Up to 8 weeks from start of feasibility study
measure: Pain interference
timeFrame: Up to 8 weeks from start of feasibility study
measure: Pain catastrophizing
timeFrame: Up to 8 weeks from start of feasibility study
measure: Depression
timeFrame: Up to 8 weeks from start of feasibility study
measure: Anxiety
timeFrame: Up to 8 weeks from start of feasibility study
measure: Cancer-related worry
timeFrame: Up to 8 weeks from start of feasibility study
measure: Physical functioning
timeFrame: Up to 8 weeks from start of feasibility study
measure: Peer relations
timeFrame: Up to 8 weeks from start of feasibility study
measure: Fatigue
timeFrame: Up to 8 weeks from start of feasibility study
measure: Sleep
timeFrame: Up to 8 weeks from start of feasibility study
measure: Global acceptability and satisfaction with treatment
timeFrame: Up to 8 weeks from start of feasibility study
measure: Opioid Use
timeFrame: Up to 8 weeks from start of feasibility study
measure: Parental depression
timeFrame: Up to 8 weeks from start of feasibility study
measure: Parental anxiety
timeFrame: Up to 8 weeks from start of feasibility study
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Tara Brinkman, Phd
role: PRINCIPAL_INVESTIGATOR
References: