What side effects are associated with this type of intervention?

The known side effects of treatments for bone sarcoma, particularly those similar to the trial involving culturally adapted mobile CBT and active tDCS, include mild side effects from tDCS such as itching, tingling, headache, and discomfort at the stimulation site. CBT, being a psychological intervention, has minimal physical side effects but may cause temporary emotional discomfort as patients work through challenging thoughts and feelings. These treatments aim to manage chronic pain effectively with minimal adverse effects.

What prior FDA approvals exist?

There is limited information on FDA approvals specifically for treatments combining cognitive-behavioral therapy (CBT) and transcranial direct current stimulation (tDCS) for Bone Sarcoma. However, traditional FDA-approved treatments for Bone Sarcoma typically include surgical resection, chemotherapy agents like methotrexate, doxorubicin, and cisplatin, and radiation therapy. For chronic pain management in cancer patients, including those with Bone Sarcoma, the FDA has approved various pharmacological treatments and some neuromodulation devices, but specific approvals for the combination of mobile CBT and tDCS are not well-documented.

What other types of research exist?

Promising novel alternatives for bone sarcoma patients in 2024 include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown significant pain reduction and improved quality of life in advanced NSCLC patients. 2) High-Definition Transcranial Alternating Current Stimulation (HD-tACS), which has demonstrated efficacy in reducing pain and psychological distress in fibromyalgia patients. 3) Integrative therapies such as guided imagery, progressive muscle relaxation, and biofeedback, which have been effective in managing chronic pain and improving quality of life in cancer patients.

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Cognitive Behavioral Therapy

Mobile CBT + tDCS for Chronic Pain after Bone Sarcoma

N/A

Recruiting

Led By Tara Brinkman, Phd

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks from start of feasibility study

Summary

This trial aims to help childhood cancer survivors who have chronic pain by using a special therapy app and a device that sends mild electrical currents to the brain. The therapy app is designed to be culturally sensitive for better effectiveness. The study will test if this combined approach can improve pain management in these patients.

Who is the study for?

This trial is for non-Hispanic Black and Hispanic survivors of pediatric bone sarcoma, aged 10-17 years, who are at least one year post-treatment. They must experience chronic pain that affects their daily life. Adults can participate if they're a survivor or parent of a survivor, over 18 years old.

What is being tested?

The study is testing a mobile Cognitive Behavior Therapy (CBT) program adapted for cultural relevance, combined with either real or sham Transcranial Direct Current Stimulation (tDCS). The goal is to see if this combination helps manage chronic pain in adolescent cancer survivors.

What are the potential side effects?

Possible side effects may include discomfort from the tDCS device like itching or tingling on the scalp, fatigue after therapy sessions, and potential emotional distress from discussing painful experiences during CBT.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks from start of feasibility study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks from start of feasibility study

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks from start of feasibility study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety

Cancer-related worry

Depression

+11 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: InterviewExperimental Treatment1 Intervention

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

Group II: Arm I (mobile CBT + active tDCS)Experimental Treatment3 Interventions

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

Group III: Arm II (mobile CBT + sham tDCS)Placebo Group3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavior Therapy

2010

Completed Phase 3

~2630

Transcranial Direct Current Stimulation

2014

Completed Phase 3

~1100

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bone sarcoma include surgery, chemotherapy, and radiation therapy. Surgery involves the physical removal of the tumor, chemotherapy uses drugs to kill cancer cells or stop them from growing, and radiation therapy uses high-energy rays to target and destroy cancer cells. The trial studying Culturally Adapted Mobile CBT and active tDCS focuses on non-pharmacological approaches to manage chronic pain. CBT helps patients develop coping strategies and change pain-related thoughts, while tDCS modulates brain activity to reduce pain perception. Understanding these mechanisms is crucial for bone sarcoma patients as it provides comprehensive pain management options, potentially improving their quality of life and functional ability.

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