Combination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
Objectives:
Primary:
To compare the effects of the combination therapy arm with the placebo arm on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) at the end of 6 weeks (primary end point). We hypothesize that there will be a greater maintenance of sleep quality in the combination arm than in the placebo arm after 6 weeks.
Secondary:
To compare the effects of the combination therapy arm with the placebo arm on sleep quality (PSQI) at 3- and 6-months post-intervention. We hypothesize that there will be a greater maintenance of sleep quality in the combination arm than in the placebo arm at 3- and 6-months post intervention.
Secondary:
To compare the effects of the remaining active therapy arms with the placebo and combination arms on sleep quality (PSQI) at all post-intervention assessments. We hypothesize that there will be a greater maintenance of sleep quality in the active arms than in the placebo arm at all post-intervention assessments. Additionally, there will be greater maintenance of sleep quality in the combination arm than in the remaining active arms.
Secondary:
To compare the effects of the active therapy arm and the placebo arm for sleep-wake cycle disturbance (Actigraphy - sleep onset latency, wake after sleep onset, total sleep time, sleep efficiency, and mean daytime activity). We hypothesize that there w/ill be greater maintenance of sleep-wake cycle (synchronization) in the combination therapy arm.
Secondary:
To determine whether the addition of MP to BLT+MT synergistically maintains sleep quality as measured by change from baseline PSQI. We hypothesize that MP and BLT+MT will synergistically maintain sleep quality.
Exploratory:
To explore the effects of the active therapy arm on psychological symptoms (Hospital Anxiety and Depression Scale), fatigue (Functional Assessment of Chronic Illness Therapy - Fatigue), sleep and related symptoms (PROMIS-Sleep), inflammation (C-reactive protein), and quality of life (Functional Assessment of Cancer Therapy - General) and how they vary over time. We hypothesize that there will be more promotion of sleep related symptoms and quality of life in the combination therapy arm than in the placebo, BLT, and Methylphenidate arms.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cognitive Behavior Therapy (called CBT) Participant would be using the CBT counseling technique found to improve sleep disturbance. |
Behavioral: Cognitive Behavior Therapy
Counseling session
|
| Experimental: Bright Light Therapy (called BLT) Participants would be utilized in the study of the BLT designed to use light to improve the sleeping/waking cycle or pattern in order to help people sleep better |
Behavioral: Bright Light Therapy
Sleep patterns
|
| Experimental: Methylphenidate Participants would be take this medication designed to increase activity of the central nervous system. |
Drug: Methylphenidate
Given by PO
|
| Experimental: Melatonin Participants would take this medication designed to show the changes in levels to help your body know when it is time to go to sleep and when it is time to wake up |
Drug: Melatonin
Given by PO
|
Outcome Measures
Primary Outcome Measures
- Edmonton Symptom Assessment System (ESAS) questionnaires [through the study completion, an average of 1 year.]
Edmonton Symptom Assessment System (ESAS) questionnaires score scale ranges (0-10) No Pain 0/10 Worst Pain Imaginable
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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;
-
ability to communicate in English;
-
cognitively competent to respond appropriately to questions, as measured by the Memorial Delirium Assessment Scale (≤ 13/30);
-
willing and able to sign a written informed consent;
-
life expectancy of ≥ 1 year as assessed by the oncologist using the "surprise question," "Would I be surprised if this patient died in the next 12 months?"; and
-
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).
Exclusion Criteria:
-
active use of systemic anti-inflammatory prescription medications;
-
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.
-
Hospital Anxiety and Depression (HADS) score ≥ 13, or use of antidepressants, unless the patient is receiving a stable dose for at least 3 months;
-
use of hypnosedative drugs or stimulants; and
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Sriram Yennu, MD, MD Anderson
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2022-0180
- NCI-2022-06045