CBT and Light Therapy for Sleep Issues in Cancer Patients

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

Recruiting Phase 2 Phase 3 Interventional Study
Sleep Fatigue Anxiety Cancer Depression
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
188 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for

This trial is looking for cancer patients who have trouble sleeping. Participants will try Cognitive Behavior Therapy along with other treatments to see if it helps improve their sleep and related symptoms.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have poor sleep quality for at least 2 weeks.
  • I am 18 years or older.
  • I can communicate in English.
  • I can sign a written consent.
  • I expect to live for at least 1 more year.
  • My pain is stable or controlled.
  • I can attend follow-up visits in Texas.

You may not be able to join if

  • I use certain prescription anti-inflammatory medications.
  • I have a history of some psychiatric illnesses or sleep disorders.
  • I have a Hospital Anxiety and Depression score of 21 or higher.
  • I take hypnosedative drugs or stimulants.
  • I have had certain eye conditions or night shift work.
  • I have had bright sunlight exposure for at least 30 minutes daily recently.
  • I cannot have an MRI due to metal in my body or claustrophobia.
  • I am currently pregnant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

To learn if Cognitive Behavior Therapy (called CBT), combined with either Bright Light Therapy (called BLT), methylphenidate, and/or melatonin, can help improve sleep and other related symptoms such as fatigue, anxiety, and depression in cancer patients. This is an investigational study. In this study, BLT, Methylphenidate and Melatonin will be compared to their placebos.

Trial Locations
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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 question…
Contacts

Sriram Yennu, MD

713-792-6085

syennu@mdanderson.org

CONTACT