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

Primary Purpose

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Sleep Disorder

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Counseling

Methylphenidate Hydrochloride

Phototherapy

Placebo Administration

Quality-of-Life Assessment

Sham Intervention

Therapeutic Melatonin

About this trial

This is an interventional supportive care trial for Hematopoietic and Lymphoid Cell Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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)
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

Sites / Locations

M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Arm I (methylphenidate, melatonin, light therapy, CBT)

Arm II (placebo, placebo, sham light therapy, CBT)

Arm III (methylphenidate, melatonin, sham light therapy, CBT)

Arm IV (methylphenidate, placebo, light therapy, CBT)

Arm V (placebo, melatonin, light therapy, CBT)

Arm VI (placebo, placebo, light therapy, CBT)

Arm VII (methylphenidate, placebo, sham light therapy, CBT)

Arm VIII (placebo, melatonin, sham light intervention, CBT)

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Pittsburgh Sleep Quality Index (PSQI) score

Estimates of treatment effects and combinations of treatment effects will be obtained by using standard linear regression techniques in which the change in PSQI values are regressed on indicator variables that represent treatment combinations that received 3 main effects for the primary treatments, 3 two-way interaction terms for each combination of two treatments, and 1 three-way interaction effects, which will be included in the linear regression model.

Secondary Outcome Measures

Change in Insomnia Severity Index scores

Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of Insomnia Severity Index. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

Change in Functional Assessment of Chronic Illness Therapy (FACIT)-F scores

Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of FACIT-F scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

Change in Hospital Anxiety Depression Scale (HADS) scores

Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of HADS scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

Change in Edmonton Symptom Assessment System (ESAS) scores

Exploratory data analyses to examine associations between patients' change in PSQI score and the secondary measure of ESAS scores. Multivariate regression analyses will also be performed to determine the predictive relationship of this variable on PSQI and change in PSQI scores.

Change in actigraphy data

Differences between participants receiving the MMT or the placebo treatment will be analyzed. This analysis will be based on fitting mixed effect linear models with actigraphy data as the response variables, and treatment intervention, demographic variables, and treatment site as independent variables.

Incidence of adverse events

Full Information

NCT ID

NCT01628029

First Posted

June 22, 2012

Last Updated

September 6, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01628029

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 15, 2014 (Actual)

Primary Completion Date

June 30, 2028 (Anticipated)

Study Completion Date

June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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 cancer when given together with methylphenidate hydrochloride, therapeutic melatonin, and light therapy.

Detailed Description

PRIMARY OBJECTIVE: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Sleep Disorder

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (methylphenidate, melatonin, light therapy, CBT)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (placebo, placebo, sham light therapy, CBT)

Arm Type

Experimental

Arm Description

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 Title

Arm III (methylphenidate, melatonin, sham light therapy, CBT)

Arm Type

Experimental

Arm Description

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 Title

Arm IV (methylphenidate, placebo, light therapy, CBT)

Arm Type

Experimental

Arm Description

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 Title

Arm V (placebo, melatonin, light therapy, CBT)

Arm Type

Experimental

Arm Description

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 Title

Arm VI (placebo, placebo, light therapy, CBT)

Arm Type

Experimental

Arm Description

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 Title

Arm VII (methylphenidate, placebo, sham light therapy, CBT)

Arm Type

Experimental

Arm Description

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 Title

Arm VIII (placebo, melatonin, sham light intervention, CBT)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Counseling

Other Intervention Name(s)

Counseling Intervention

Intervention Description

Undergo CBT

Intervention Type

Drug

Intervention Name(s)

Methylphenidate Hydrochloride

Other Intervention Name(s)

Concerta, Quillivant XR, Ritalin

Intervention Description

Given PO

Intervention Type

Procedure

Intervention Name(s)

Phototherapy

Other Intervention Name(s)

Actinotherapy, Bright Light Therapy, light therapy

Intervention Description

Undergo light therapy

Intervention Type

Other

Intervention Name(s)

Placebo Administration

Intervention Description

Given PO

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Procedure

Intervention Name(s)

Sham Intervention

Other Intervention Name(s)

Sham Comparator

Intervention Description

Undergo sham light therapy

Intervention Type

Drug

Intervention Name(s)

Therapeutic Melatonin

Other Intervention Name(s)

Circadin, Melatonin, Melaxen

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

Change in Pittsburgh Sleep Quality Index (PSQI) score

Description

Time Frame

Baseline up to day 29

Secondary Outcome Measure Information:

Title

Change in Insomnia Severity Index scores

Description

Time Frame

Baseline up to day 29

Title

Change in Functional Assessment of Chronic Illness Therapy (FACIT)-F scores

Description

Time Frame

Baseline up to day 29

Title

Change in Hospital Anxiety Depression Scale (HADS) scores

Description

Time Frame

Baseline up to day 29

Title

Change in Edmonton Symptom Assessment System (ESAS) scores

Description

Time Frame

Baseline up to day 29

Title

Change in actigraphy data

Description

Time Frame

Baseline up to day 15

Title

Incidence of adverse events

Time Frame

Up to 45 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sriram Yennu

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31924662

Citation

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.

Results Reference

derived

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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