Hematopoietic and Lymphoid Cell NeoplasmPhase 2NCT01628029

Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer

A Phase 2 study testing Counseling, Methylphenidate Hydrochloride and Phototherapy in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Sleep Disorder
What is being tested?: Counseling, Methylphenidate Hydrochloride and Phototherapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2014to 31 Dec 2028
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cancer patients currently on cancer therapy with a positive screening for SD (screening PSQI score >= 5)
Patients should have a Zubrod =< 2
Patients with no pain and with stable pain (defined as pain under control and on stable doses of opioids for 1 week) are eligible
Memorial delirium assessment scale =< 13
Controlled pain and depression symptoms, if present (defined as no change in the morphine equivalent dose of 30% or change in the dose of antidepressant medication in the past 2 weeks)
All patients who are receiving chemotherapy and/or radiation therapy are eligible for study if they have completed > 1 week of radiation therapy, and if they have been approved to go on study by their primary oncologist; the principal investigator (PI)/designated research staff of this study will obtain and document approval from the primary oncologist and principal investigator of the clinical trial in case the patient is on another clinical trial as referenced in the patient's study documents

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Serum creatinine =< 2.0 mg/dL
Total bilirubin =< 1.5 mg/dL
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x upper limit of normal (ULN) or =< 5 x ULN if hepatic metastases are present
Patients on stable doses (defined as same dose for 2 weeks) of dexamethasone, mirtazapine, zolpidem, benzodiazepines, phenothiazines are allowed to participate in the study

Who cannot join

Have a major contraindication to methylphenidate (MP) (e.g., allergy/hypersensitivity to study medications or their constituents), light therapy (e.g., currently receiving ultraviolet A [UVA]/ultraviolet B [UVB] therapy), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician
Currently taking MP or have taken it within the previous 10 days
Patients with a diagnosis of polysomnographically confirmed obstructive sleep apnea or narcolepsy
Regularly used cognitive behavioral therapy in the last 6 weeks for sleep disturbance
Unable to complete the baseline assessment forms or to understand the recommendations for participation in the study
Currently with a diagnosis of major depression, manic depressive disorder, obsessive-compulsive disorder, or schizophrenia)

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Need monoamine oxidase inhibitors, tricyclic antidepressants, or clonidine
Have glaucoma
Symptomatic tachycardia and uncontrolled hypertension (determined to be clinically significant by the PI)
Currently receiving anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, clonidine, and/or tricyclic drugs (imipramine, clomipramine, or desipramine)
Unable to speak and understand English
Persons with congenital blindness and self-reported acquired blindness (independent of the cause) with no light perception
Patients with a history of retinal disease
Patients with > 2 hours of direct exposure to outdoor natural light per day by interview with the Study Coordinator
Patients with a diagnosis of obesity hypoventilation syndrome
Positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated beta (b)-human chorionic gonadotropin (HCG), these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth control specifications: women who are able to become pregnant must use birth control during the study and for 30 days after
Women who are nursing
Patients who have taken melatonin within the past two weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer

Read the detailed description

PRIMARY OBJECTIVE:

To obtain preliminary estimates of the effects of cognitive behavioral therapy (CBT) and various treatments (light therapy, melatonin, methylphenidate [methylphenidate hydrochloride]) and combinations of treatments in multimodal therapy (MMT) in reducing sleep disturbance in patients with cancer, as measured by change in Pittsburgh Sleep Quality Index (PSQI) scores taken at baseline and on day 15.

SECONDARY OBJECTIVES:

To explore the effect of MMT on Insomnia Severity Index, cancer related symptoms (fatigue [Functional Assessment of Chronic Illness Therapy (FACIT-F) subscale, Edmonton Symptom Assessment System (ESAS)], anxiety, depression anxiety [Hospital Anxiety Depression Scale (HADS), ESAS]), quality of life (Functional Assessment of Cancer Therapy-General [FACT-G], ESAS), and physical activity/sleep efficacy (actigraphy), before and after treatment with various sleep disturbance (SD) treatment combinations of MMT.

II. To determine the safety of MMT (type, frequency, and severity of the adverse events).

OUTLINE: Patients are randomized to 1 of 8 treatment arms.

ARM I: Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride orally (PO) twice daily (BID) and therapeutic melatonin PO once daily (QD), and undergo light therapy over 30 minutes for 15 days.

ARM II: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.

ARM III: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.

ARM IV: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.

ARM V: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days.

ARM VI: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days.

ARM VII: Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days.

ARM VIII: Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days.

Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up on days 29 and 45.

Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Sleep Disorder
Being tested: Counseling, Methylphenidate Hydrochloride, Phototherapy, Placebo Administration, Quality-of-Life Assessment
Medical subject headings: Hematologic Neoplasms, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CounselingOther
Also called Counseling Intervention
Undergo CBT
Methylphenidate HydrochlorideDrug
Also called Concerta, Quillivant XR, Ritalin
Given PO
PhototherapyProcedure or surgery
Also called Actinotherapy, Bright Light Therapy, light therapy
Undergo light therapy
Placebo AdministrationOther
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Sham InterventionProcedure or surgery
Also called Sham Comparator
Undergo sham light therapy
Therapeutic MelatoninDrug
Also called Circadin, Melatonin, Melaxen
Given PO

Study groups in NCT01628029
Study group	Role	What they receive
Arm I (methylphenidate, melatonin, light therapy, CBT)	Experimental	Patients undergo CBT comprising 3 30-minute counseling sessions between baseline and day 14. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days. Receives: Other: Counseling; Drug: Methylphenidate Hydrochloride; Procedure: Phototherapy; Other: Quality-of-Life Assessment; Drug: Therapeutic Melatonin
Arm II (placebo, placebo, sham light therapy, CBT)	Experimental	Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days. Receives: Other: Counseling; Other: Placebo Administration; Other: Quality-of-Life Assessment; Procedure: Sham Intervention
Arm III (methylphenidate, melatonin, sham light therapy, CBT)	Experimental	Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days. Receives: Other: Counseling; Drug: Methylphenidate Hydrochloride; Other: Quality-of-Life Assessment; Procedure: Sham Intervention; Drug: Therapeutic Melatonin
Arm IV (methylphenidate, placebo, light therapy, CBT)	Experimental	Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days. Receives: Other: Counseling; Drug: Methylphenidate Hydrochloride; Procedure: Phototherapy; Other: Placebo Administration; Other: Quality-of-Life Assessment
Arm V (placebo, melatonin, light therapy, CBT)	Experimental	Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo light therapy over 30 minutes for 15 days. Receives: Other: Counseling; Procedure: Phototherapy; Other: Placebo Administration; Other: Quality-of-Life Assessment; Drug: Therapeutic Melatonin
Arm VI (placebo, placebo, light therapy, CBT)	Experimental	Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and melatonin placebo PO QD, and undergo light therapy over 30 minutes for 15 days. Receives: Other: Counseling; Procedure: Phototherapy; Other: Placebo Administration; Other: Quality-of-Life Assessment
Arm VII (methylphenidate, placebo, sham light therapy, CBT)	Experimental	Patients undergo CBT as in Arm I. Patients also receive methylphenidate hydrochloride PO BID and melatonin placebo PO QD, and undergo sham light therapy over 30 minutes for 15 days. Receives: Other: Counseling; Drug: Methylphenidate Hydrochloride; Other: Placebo Administration; Other: Quality-of-Life Assessment; Procedure: Sham Intervention
Arm VIII (placebo, melatonin, sham light intervention, CBT)	Experimental	Patients undergo CBT as in Arm I. Patients also receive methylphenidate placebo PO BID and therapeutic melatonin PO QD, and undergo sham light therapy over 30 minutes for 15 days. Receives: Other: Counseling; Other: Placebo Administration; Other: Quality-of-Life Assessment; Procedure: Sham Intervention; Drug: Therapeutic Melatonin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pittsburgh Sleep Quality Index (PSQI) Score Change
PSQI consists of 19 items, and it measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component score ranges from 0 (no difficulty/good) to 3 (severe difficulty/poor). The global PSQI score is then calculated by totaling (summed) seven component scores, providing an overall score ranging from 0 to 21, where 0 indicates very good sleep quality and 21 signifies very poor sleep quality. A global score of greater than 5 often suggests significant sleep problems. In this study, Wilcoxon signed-rank test was used to determine the p value.
Measured: Baseline and Day 15

Secondary outcomes (3)

Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
There are 13 items in this FACIT-F subscale. In this subscale, the patient rates the intensity of fatigue and its related symptoms on a scale from 0 to 4 in the past week. The total score can range between 0 and 52, with higher scores denoting less fatigue. Wilcoxon signed-rank test was used to determine the p-value.
Measured: Baseline and Day 15
Insomnia Severity Index (ISI)) Score Change
The ISI is a 7-item questionnaire designed to evaluate insomnia severity. Each item is rated using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much), for a total score ranging from 0 to 28 with a cut-off score of 10 or greater indicating significant insomnia. Wilcoxon signed-rank test was used to determine the p-value.
Measured: Baseline and Day 15
Functional Assessment of Cancer Therapy - General (FACT-G) Score Change
The FACT-G is a quality-of-life instrument that is commonly used in cancer clinical trials. FACT-G consists of 27 general quality-of-life questions divided into 4 domains (physical, social, emotional and functional). The patient rates the intensity of symptoms on a Likert scale from 0 (not at all) to 4 (very much). Total score ranges from 0-108 with higher score indicates better Quality of Life. Wilcoxon signed-rank test was used to determine the p-value.
Measured: Baseline and Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201431 Dec 2028

First posted26 Jun 2012 (estimated)
Study start15 Jan 2014
Primary completion22 Dec 2025
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01628029
Sponsor's protocol ID: 2012-0120
Other IDs: NCI-2012-01352, 2012-0120
Status last verified: May 2026
First submitted: 22 Jun 2012
Last updated: 22 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Yennurajalingam S, Carmack C, Balachandran D, Eng C, Lim B, Delgado M, Guzman Gutierrez D, Raznahan M, Park M, Hess KR, Williams JL, Lu Z, Ochoa J, Bruera E. Sleep disturbance in patients with cancer: a feasibility study of multimodal therapy. BMJ Support Palliat Care. 2021 Jun;11(2):170-179. doi: 10.1136/bmjspcare-2019-001877. Epub 2020 Jan 10.
PubMed 31924662

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer
ClinicalTrials.gov ID: NCT01628029
Acronym / sponsor ID: 2012-0120
Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Sleep Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 68 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 15 Jan 2014 (actual)
Primary completion: 22 Dec 2025 (actual)
Study completion: 31 Dec 2028 (estimated)
First posted: 26 Jun 2012 (estimated)
Results: Posted 4 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVE:

To obtain preliminary estimates of the effects of cognitive behavioral therapy (CBT) and various treatments (light therapy, melatonin, methylphenidate [methylphenidate hydrochloride]) and combinations of treatments in multimodal therapy (MMT) in reducing sleep disturbance in patients with cancer, as measured by change in Pittsburgh Sleep Quality Index (PSQI) scores taken at baseline and on day 15.

SECONDARY OBJECTIVES:

To explore the effect of MMT on Insomnia Severity Index, cancer related symptoms (fatigue [Functional Assessment of Chronic Illness Therapy (FACIT-F) subscale, Edmonton Symptom Assessment System (ESAS)], anxiety, depression anxiety [Hospital Anxiety Depression Scale (HADS), ESAS]), quality of life (Functional Assessment of Cancer Therapy-General [FACT-G], ESAS), and physical activity/sleep efficacy (actigraphy), before and after treatment with various sleep disturbance (SD) treatment combinations of MMT.