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Prevention of Delirium After Bone Marrow Transplantation

Primary Purpose

Delirium

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright light therapy
Sham light
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Delirium, Hematopoietic stem cell transplantation, Bone marrow transplantation, Bright Light Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 or older
  • Male or female
  • Patients scheduled to undergo HSCT
  • English speaking

Exclusion Criteria:

  • Previous history of bipolar affective disorder
  • On-going delirium
  • History of substance abuse/dependence within 6 months prior to HSCT
  • History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins
  • History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria
  • Eye condition that makes eyes vulnerable to light damage
  • Concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement St. John's Wort
  • Established primary insomnia

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright light therapy

Sham light

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
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)

Secondary Outcome Measures

Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
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
Average Dose of Antipsychotic Medications Required to Manage Delirium
Hospital Length of Stay
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
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).
Serum Creatinine and Blood Urea Nitrogen (BUN)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Red Blood Cells (RBC)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
White Blood Cells (WBC)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Hemoglobin (HGB)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Hematocrit (HCT)
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.
Platelet Count
Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.

Full Information

First Posted
October 1, 2012
Last Updated
May 26, 2017
Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01700816
Brief Title
Prevention of Delirium After Bone Marrow Transplantation
Official Title
Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Low incidence of delirium.
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Cancer Society, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.
Detailed Description
This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition. Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there). Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Hematopoietic stem cell transplantation, Bone marrow transplantation, Bright Light Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright light therapy
Arm Type
Experimental
Arm Description
2500 Lux gaze directed every morning from 8 am until 8:30 am
Arm Title
Sham light
Arm Type
Placebo Comparator
Arm Description
<1000 Lux gaze directed every morning from 8 am until 8:30 am
Intervention Type
Device
Intervention Name(s)
Bright light therapy
Other Intervention Name(s)
DL930 Day-Light Classic by Uplift Technologies Inc.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham light
Other Intervention Name(s)
DL930 Day-Light Classic Uplift Tecnologies placebo box
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
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
Secondary Outcome Measure Information:
Title
Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)
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
Title
Average Dose of Antipsychotic Medications Required to Manage Delirium
Time Frame
From admission to hospital to discharge, an expected average of 28 days post-transplant
Title
Hospital Length of Stay
Time Frame
From admission to hospital to discharge, an expected average of 28 days post-transplant
Title
Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)
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
Title
Serum Creatinine and Blood Urea Nitrogen (BUN)
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
Title
Red Blood Cells (RBC)
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
Title
White Blood Cells (WBC)
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
Title
Hemoglobin (HGB)
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
Title
Hematocrit (HCT)
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
Title
Platelet Count
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 or older Male or female Patients scheduled to undergo HSCT English speaking Exclusion Criteria: Previous history of bipolar affective disorder On-going delirium History of substance abuse/dependence within 6 months prior to HSCT History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria Eye condition that makes eyes vulnerable to light damage Concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement St. John's Wort Established primary insomnia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Fernandez-Robles, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Prevention of Delirium After Bone Marrow Transplantation

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