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

St. Jude Children's Research Hospital

Status: Completed

Conditions: Bone Sarcoma; Childhood Cancer

Treatments: Drug: Placebo Administration; Behavioral: Cognitive Behavior Therapy; Other: Questionnaire Administration; Other: Interview; Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05746429

ADAPTED

R61CA280978 (U.S. NIH Grant/Contract)

NCI-2022-10013 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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
• History of brain tumor diagnosis

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 3 patient groups

Arm I (mobile CBT + active tDCS)

Experimental group

Description:

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

Treatment:

Device: Transcranial Direct Current Stimulation

Other: Questionnaire Administration

Behavioral: Cognitive Behavior Therapy

Arm II (mobile CBT + sham tDCS)

Sham Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Drug: Placebo Administration

Behavioral: Cognitive Behavior Therapy

Interview

Experimental group

Description:

Participants attend virtual meetings and virtual focus groups during the cultural adaptation phase. Feedback is collected and analyzed to develop the finalized adaptation.

Treatment:

Other: Interview