Trial Summary
What is the purpose of this trial?
This randomized phase II trial studies how well cognitive behavioral therapy and multimodal therapy works in treating sleep disturbance in patients with cancer. Cognitive behavioral therapy may help reduce sleep disturbances, fatigue, and insomnia as well as improve the well-being and quality of life of patients with cancer when given together with methylphenidate hydrochloride, therapeutic melatonin, and light therapy.
Research Team
Sriram Yennu
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for cancer patients experiencing sleep disturbances, on stable pain control, and undergoing cancer therapy. They must have a certain level of physical functioning (Zubrod <= 2), controlled symptoms of pain and depression, normal organ function tests, and not be on excluded medications or have specific conditions like blindness or major psychiatric disorders.Inclusion Criteria
Exclusion Criteria
Treatment Details
Interventions
- Cognitive Behavioral Therapy (Behavioural Intervention)
- Methylphenidate Hydrochloride (Other)
- Multimodal Therapy (Behavioural Intervention)
- Phototherapy (Procedure)
- Therapeutic Melatonin (Other)
Cognitive Behavioral Therapy is already approved in European Union, United States, Canada, Australia for the following indications:
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Substance use disorders
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
- Anxiety disorders
- Depressive disorders
- Eating disorders
- Post-traumatic stress disorder (PTSD)
- Obsessive-compulsive disorder (OCD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator