Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer

Launched by M.D. ANDERSON CANCER CENTER · Jul 23, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a combination of therapies on sleep disturbances in patients with advanced cancer. Researchers want to find out if Cognitive Behavior Therapy (CBT) along with treatments like Bright Light Therapy (BLT), methylphenidate (a medication often used for attention issues), and melatonin (a natural sleep aid) can improve not just sleep, but also related problems like fatigue, anxiety, and depression. Participants will be compared to others receiving placebos, which are inactive treatments, to see which approach works better.

To be eligible for this study, participants should be between the ages of 65 and 74, be able to communicate in English, and have experienced poor sleep for at least two weeks. They should also have a life expectancy of at least one year and not be in significant pain. Patients with certain psychiatric conditions, sleep disorders, or those taking specific medications may not be eligible. If you decide to join, you can expect to take part in therapy sessions and possibly receive one of the treatments being tested. It's important to know that this study is still in the recruiting phase, so there may be opportunities to participate if you meet the criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. presence of poor sleep quality, defined as Pittsburgh Sleep Quality Index (PSQI) total score ≥ 5, with patients describing poor sleep as being present for a minimum of 2 weeks;
• • 2. ability to communicate in English;
• • 3. cognitively competent to respond appropriately to questions, as measured by the Memorial Delirium Assessment Scale (MDAS) (≤ 13/30);
• • 4. willing and able to sign a written informed consent;
• • 5. life expectancy of ≥ 1 year as assessed by the oncologist or the principal investigator (SY) using the "surprise question," "Would I be surprised if this patient died in the next 12 months?"; and
• • 6. no pain or stable pain (defined as pain ≤ 4 on Edmonton Symptom Assessment Scale (ESAS) or under control and on stable doses of opioids for 1 month).
• • 7. Age 18 years or older
• • 8. be willing to complete in-person or telemedicine follow-up visits with research staff, and able to complete CBT intervention either in person or virtually within Texas.
• Exclusion Criteria:
• • 1. active use of systemic anti-inflammatory prescription medications including steroids; unless used during or prior to cancer treatment as a prophylaxis (i.e., nausea);
• • 2. known history of psychiatric illness (e.g., schizophrenia, bipolar disorder, major depressive disorder), sleep disorder (e.g., obstructive sleep apnea, narcolepsy, periodic limb movement disorder), obesity hypoventilation syndrome, glaucoma, congenital blindness, self-reported acquired blindness, significant cataracts or retinal disease; and night shift workers.
• • 3. Hospital Anxiety and Depression (HADS) score ≥21, or use of antidepressants, unless the patient is receiving a stable dose for at least 1 month;
• • 4. use of hypnosedative drugs or stimulants; unless on stable doses of hypnosedative drugs or stimulants for at least 1 month;
• • 5. use of monoamine oxidase inhibitors (MOI), tricyclic anti-depressants and anticoagulants; and
• • 6. patients who have bright sunlight exposure for consecutive 30 minutes or more daily in the past month, or prior exposure to BLT, or prior use of MT, MP, or CBT.
• • 7. other medical reason that increases patient risk as determined by PI.
• 8. For patients participating in the MRI data collection component of the study, we will exclude the participants who meet the following criteria:
• • 1. . Any metallic objects in the body. Metal plates, certain types of dental braces, cardiac pacemakers, ext., that are sensitive to electromagnetic fields contraindicate MRI scans
• • 2. . Claustrophobia
• • 9. Pregnancy as documented in the medical record