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Trial record 1 of 2 for:    11754849 [PUBMED-IDS]
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Prevention of Delirium After Bone Marrow Transplantation

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ClinicalTrials.gov Identifier: NCT01700816
Recruitment Status : Terminated (Low incidence of delirium.)
First Posted : October 4, 2012
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Carlos Fernandez-Robles, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Condition Delirium
Interventions Device: Bright light therapy
Device: Sham light
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Period Title: Overall Study
Started 21 19
Completed 21 19
Not Completed 0 0
Arm/Group Title Bright Light Therapy Sham Light Total
Hide Arm/Group Description

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
53.3  (12.84) 53.1  (14.15) 53.2  (13.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
3
  14.3%
9
  47.4%
12
  30.0%
Male
18
  85.7%
10
  52.6%
28
  70.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Non Hispanic White Number Analyzed 18 participants 17 participants 35 participants
16
  88.9%
17
 100.0%
33
  94.3%
Hispanic or Latino Number Analyzed 18 participants 17 participants 35 participants
1
   5.6%
0
   0.0%
1
   2.9%
Asian Number Analyzed 18 participants 17 participants 35 participants
1
   5.6%
0
   0.0%
1
   2.9%
[1]
Measure Analysis Population Description: Information not provided during interviews by all participants
Marital Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Married/Partnered Number Analyzed 17 participants 17 participants 34 participants
12
  70.6%
13
  76.5%
25
  73.5%
Single/Divorced/Widowed Number Analyzed 17 participants 17 participants 34 participants
5
  29.4%
4
  23.5%
9
  26.5%
[1]
Measure Analysis Population Description: Information not provided during interviews by all participants
Highest Education Level   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
11th grade or less Number Analyzed 17 participants 15 participants 32 participants
1
   5.9%
0
   0.0%
1
   3.1%
High School degree/GED Number Analyzed 21 participants 19 participants 40 participants
2
   9.5%
6
  31.6%
8
  20.0%
Some College Number Analyzed 21 participants 19 participants 40 participants
2
   9.5%
2
  10.5%
4
  10.0%
Completed College Number Analyzed 21 participants 19 participants 40 participants
12
  57.1%
7
  36.8%
19
  47.5%
[1]
Measure Analysis Population Description: Information not provided during interviews by all participants
1.Primary Outcome
Title Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
Hide Description Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
Time Frame From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 20 bright light therapy and 18 sham light participants were analyzed because 2 participants (one from each arm) only had one assessment. Consequently, no change could be documented to analyze change of delirium scales. They did not drop out; they just completed their transplant before more data could be gathered.
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 20 18
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.0%
0
   0.0%
2.Secondary Outcome
Title Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
Hide Description

Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.

10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.

A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium

Time Frame From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only one case of delirium developed, and only an MDAS score was collected for this participant.
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: units on a scale
18
3.Secondary Outcome
Title Average Dose of Antipsychotic Medications Required to Manage Delirium
Hide Description [Not Specified]
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant.
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Hospital Length of Stay
Hide Description [Not Specified]
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One participant in the sham light arm was missing date of discharge, so only 18 hospital lengths of stay were able to be calculated in that arm.
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 21 18
Median (Inter-Quartile Range)
Unit of Measure: days
18
(17 to 21)
18.5
(15 to 22)
5.Secondary Outcome
Title Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
Hide Description Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 13 12
Median (Inter-Quartile Range)
Unit of Measure: mmol/L
Sodium (Na)
139
(137 to 139)
138.0
(136.0 to 140.5)
Potassium (K)
3.6
(3.5 to 3.8)
3.80
(3.45 to 4.30)
Chloride (Cl)
105
(103 to 105)
103.0
(102.0 to 106.5)
Carbon Dioxide (CO2)
24.9
(24.6 to 26.6)
25.10
(23.40 to 26.55)
6.Secondary Outcome
Title Serum Creatinine and Blood Urea Nitrogen (BUN)
Hide Description Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 13 12
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
Serum Creatinine
0.66
(0.54 to 0.84)
0.75
(0.47 to 0.84)
Blood Urea Nitrogen (BUN)
9
(6 to 12)
8.5
(4.5 to 10.5)
7.Secondary Outcome
Title Red Blood Cells (RBC)
Hide Description Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 13 12
Median (Inter-Quartile Range)
Unit of Measure: M/uL
3.21
(2.88 to 3.31)
2.93
(2.80 to 3.16)
8.Secondary Outcome
Title White Blood Cells (WBC)
Hide Description Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 13 12
Median (Inter-Quartile Range)
Unit of Measure: K/uL
2.30
(2.10 to 4.00)
4.75
(1.55 to 7.40)
9.Secondary Outcome
Title Hemoglobin (HGB)
Hide Description Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 13 12
Median (Inter-Quartile Range)
Unit of Measure: g/dl
9.70
(8.90 to 10.20)
9.55
(8.85 to 9.90)
10.Secondary Outcome
Title Hematocrit (HCT)
Hide Description Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 13 12
Median (Inter-Quartile Range)
Unit of Measure: volume percentage (vol%) of red blood ce
28.20
(25.20 to 29.90)
26.70
(25.70 to 28.65)
11.Secondary Outcome
Title Platelet Count
Hide Description Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Time Frame From admission to hospital to discharge, an expected average of 28 days post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description:

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

Overall Number of Participants Analyzed 13 12
Median (Inter-Quartile Range)
Unit of Measure: thousand cells/uL
39
(33 to 94)
33.5
(24.5 to 47.5)
Time Frame 28 days post-transplant or discharge, whichever comes first
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bright Light Therapy Sham Light
Hide Arm/Group Description

2500 Lux gaze directed every morning from 8 am until 8:30 am

Bright light therapy: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user’s eyes daily from 8 am to 8:30 am.

<1000 Lux gaze directed every morning from 8 am until 8:30 am

Sham light: The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.

All-Cause Mortality
Bright Light Therapy Sham Light
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bright Light Therapy Sham Light
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bright Light Therapy Sham Light
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Carlos Fernandez Robles MD
Organization: Massachusetts General Hospital
Phone: 6176432410
Publications:
Reitan RM. Validity of the Trail Making test as an indicator of organic brain damage. Perceptual and Motor Skills 8: 271-276, 1958.
Derogatis LR, Savitz, KL. The SCL-90-R and the Brief Symptom Inventory (BSI) in Primary Care In: M.E.Maruish, ed. Handbook of psychological assessment in primary care settings 236: 297,334, 2000. Mahwah, NJ: Lawrence Erlbaum Associates.
Responsible Party: Carlos Fernandez-Robles, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01700816     History of Changes
Other Study ID Numbers: 2010P002801
First Submitted: October 1, 2012
First Posted: October 4, 2012
Results First Submitted: October 27, 2016
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017