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

NCT ID: NCT05746429

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2024-10-29

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.

Conditions

Bone Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (mobile CBT + active tDCS)

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

Group Type: EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type: BEHAVIORAL

Receive mobile CBT

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

Undergo active tDCS

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II (mobile CBT + sham tDCS)

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

Group Type: SHAM_COMPARATOR

Cognitive Behavior Therapy

Intervention Type: BEHAVIORAL

Receive mobile CBT

Placebo Administration

Intervention Type: DRUG

Undergo sham tDCS

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interview

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

Group Type: EXPERIMENTAL

Interview

Intervention Type: OTHER

Attend virtual meetings and focus groups

Interventions

Cognitive Behavior Therapy

Receive mobile CBT

Intervention Type: BEHAVIORAL

Transcranial Direct Current Stimulation

Undergo active tDCS

Intervention Type: DEVICE

Interview

Attend virtual meetings and focus groups

Intervention Type: OTHER

Placebo Administration

Undergo sham tDCS

Intervention Type: DRUG

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

CBT, CBT, cognitive behavior therapy, cognitive therapy, CT; tDCS

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Adults/Adolescents

o Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

• 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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tara Brinkman, Phd

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

NCI-2022-10013

Identifier Type: OTHER

Identifier Source: secondary_id

R61CA280978

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ADAPTED

Identifier Type: -

Identifier Source: org_study_id