Trial · NCT01628029

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

NCT01628029, Phase 2, Active not recruiting, M.D. Anderson Cancer Center; results first posted 2026-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer. Trials, record NCT01628029. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01628029

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cognitive Behavioral Therapy and Multimodal Therapy in Treating Sleep Disturbance in Patients With Cancer
NCT number: NCT01628029
Status: Active not recruiting
Phases: Phase 2
Enrollment: 68 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Sleep Disorder
Interventions: Counseling, Methylphenidate Hydrochloride, Phototherapy, Placebo Administration, Quality-of-Life Assessment, Sham Intervention, Therapeutic Melatonin
First posted: 2012-06-26
Last updated: 2026-11-12
Results first posted: 2026-02-04

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pittsburgh Sleep Quality Index (PSQI) Score Change	Baseline and Day 15	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.
Secondary	Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change	Baseline and Day 15	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.
Secondary	Insomnia Severity Index (ISI)) Score Change	Baseline and Day 15	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.
Secondary	Functional Assessment of Cancer Therapy - General (FACT-G) Score Change	Baseline and Day 15	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pittsburgh Sleep Quality Index (PSQI) Score Change	Baseline and Day 15	Those who completed the study assessment and treatment	score on a scale	MEAN
SECONDARY	Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change	Baseline and Day 15	Those who completed the study assessment and treatment	score on a scale	MEDIAN
SECONDARY	Insomnia Severity Index (ISI)) Score Change	Baseline and Day 15	Those who completed the study assessment and treatment	score on a scale	MEDIAN
SECONDARY	Functional Assessment of Cancer Therapy - General (FACT-G) Score Change	Baseline and Day 15	Those who completed the study assessment and treatment	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Pittsburgh Sleep Quality Index (PSQI) Score Change	Dim Red Light + Placebo + Placebo	-1.5	Inter-Quartile Range -5.0 to 0.0	score on a scale
Pittsburgh Sleep Quality Index (PSQI) Score Change	Bright White Light Therpay + Melatonin + Placebo	-6.5	Inter-Quartile Range -8.0 to -4.0	score on a scale
Pittsburgh Sleep Quality Index (PSQI) Score Change	Dim Red Light + Melatonin + Methylphenidate	-1.0	Inter-Quartile Range -5.0 to 0.0	score on a scale
Pittsburgh Sleep Quality Index (PSQI) Score Change	Bright White Light Therapy + Placebo + Methylphenidate	-3.0	Inter-Quartile Range -6.0 to 1.5	score on a scale
Pittsburgh Sleep Quality Index (PSQI) Score Change	Bright White Light Therapy + Placebo + Placebo	-3.0	Inter-Quartile Range -8.0 to -1.0	score on a scale
Pittsburgh Sleep Quality Index (PSQI) Score Change	Dim Red Light + Melatonin + Placebo	-2.0	Inter-Quartile Range -5.0 to 2.0	score on a scale
Pittsburgh Sleep Quality Index (PSQI) Score Change	Dim Red Light + Placebo + Methylphenidate	-3.0	Inter-Quartile Range -3.0 to -2.0	score on a scale
Pittsburgh Sleep Quality Index (PSQI) Score Change	Bright White Light Therapy + Melatonin + Methylphenidate	-5.0	Inter-Quartile Range -7.0 to -2.0	score on a scale
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change	Dim Red Light + Placebo + Placebo	7.0	Inter-Quartile Range 1.5 to 15.0	score on a scale
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change	Bright White Light Therpay + Melatonin + Placebo	2.5	Inter-Quartile Range -5.0 to 16.0	score on a scale

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Dim Red Light + Placebo + Placebo	9
Overall Study	STARTED	Bright White Light Therpay + Melatonin + Placebo	8
Overall Study	STARTED	Dim Red Light + Melatonin + Methylphenidate	8
Overall Study	STARTED	Bright White Light Therapy + Placebo + Methylphenidate	9
Overall Study	STARTED	Bright White Light Therapy + Placebo + Placebo	9
Overall Study	STARTED	Dim Red Light + Melatonin + Placebo	8
Overall Study	STARTED	Dim Red Light + Placebo + Methylphenidate	7
Overall Study	STARTED	Bright White Light Therapy + Melatonin + Methylphenidate	9
Overall Study	COMPLETED	Dim Red Light + Placebo + Placebo	8
Overall Study	COMPLETED	Bright White Light Therpay + Melatonin + Placebo	6

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events80

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Dim Red Light + Placebo + Placebo	0	9
other	Abdominal pain	Gastrointestinal disorders	Bright White Light Therpay + Melatonin + Placebo	0	6
other	Abdominal pain	Gastrointestinal disorders	Dim Red Light + Melatonin + Methylphenidate	0	7
other	Abdominal pain	Gastrointestinal disorders	Bright White Light Therapy + Placebo + Methylphenidate	0	9
other	Abdominal pain	Gastrointestinal disorders	Bright White Light Therapy + Placebo + Placebo	0	9
other	Abdominal pain	Gastrointestinal disorders	Dim Red Light + Melatonin + Placebo	0	8
other	Abdominal pain	Gastrointestinal disorders	Dim Red Light + Placebo + Methylphenidate	1	7
other	Abdominal pain	Gastrointestinal disorders	Bright White Light Therapy + Melatonin + Methylphenidate	0	9
other	Anemia	Blood and lymphatic system disorders	Dim Red Light + Placebo + Placebo	0	9
other	Anemia	Blood and lymphatic system disorders	Bright White Light Therpay + Melatonin + Placebo	0	6

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dim Red Light + Placebo + Placebo	1	9
Total, all-cause mortality	Bright White Light Therpay + Melatonin + Placebo	0	6
Total, all-cause mortality	Dim Red Light + Melatonin + Methylphenidate	0	7
Total, all-cause mortality	Bright White Light Therapy + Placebo + Methylphenidate	0	9
Total, all-cause mortality	Bright White Light Therapy + Placebo + Placebo	0	9
Total, all-cause mortality	Dim Red Light + Melatonin + Placebo	0	8
Total, all-cause mortality	Dim Red Light + Placebo + Methylphenidate	0	7
Total, all-cause mortality	Bright White Light Therapy + Melatonin + Methylphenidate	0	9
Total, other adverse events	Dim Red Light + Placebo + Placebo	4	9
Total, other adverse events	Bright White Light Therpay + Melatonin + Placebo	0	6

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31924662	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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