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Treating Cancer-Related Fatigue Through Systematic Light Exposure

Primary Purpose

Hematopoietic Stem Cell Transplantation, Breast Cancer, Fatigue

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright white light
Dim red light
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic Stem Cell Transplantation focused on measuring Fatigue, Sleep, Quality of life, Cancer, Light

Eligibility Criteria

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

Inclusion Criteria:

Patients:

  • With a history of HSCT as treatment for hematological malignancies and related diseases and who are up to 3.5 years post-transplant; OR
  • Who are up to three and a half years post completion of chemotherapy OR chemotherapy and radiation for breast cancer with a curative intent;

AND:

  • With a score equal to or less than 33 on the FACIT-Fatigue scale (see below) and no pre-existing anemia (Hb<10gm/dl); or a score equal to or greater than 43 on the Cognitive Failures Questionnaire
  • Who are currently over age 18 and at least age 16 at the time of HSCT or time of breast cancer treatment

Exclusion Criteria:

  • Under age 18;
  • Pregnancy;
  • Confounding underlying medical illnesses;
  • History of mania (which is a contra-indication for light treatment) or current clinical depression;
  • And any other physical or psychological impairments including a sleep disorder diagnosis which would limit participation.

Sites / Locations

  • Hackensack University Medical Center
  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bright white light

Dim red light

Arm Description

using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box

using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box

Outcomes

Primary Outcome Measures

FACIT-Fatigue Scale
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days. Measured at baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use
FACIT-Fatigue Scale
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.
FACIT-Fatigue Scale
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.

Secondary Outcome Measures

The Pittsburgh Sleep Quality Index
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints). Baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use
The Pittsburgh Sleep Quality Index
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints).
The Pittsburgh Sleep Quality Index
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints.
SF-36 Scale
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
SF-36 Scale
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
SF-36 Scale
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
CNS-Vital Signs
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
CNS-Vital Signs
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
CNS-Vital Signs
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
The Cognitive Failures Questionnaire
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
The Cognitive Failures Questionnaire
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
The Cognitive Failures Questionnaire
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
Brief Symptom Inventory-18
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Brief Symptom Inventory-18
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Brief Symptom Inventory-18
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Actiwatch Spectrum
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Actiwatch Spectrum
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Actiwatch Spectrum
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.

Full Information

First Posted
June 6, 2013
Last Updated
April 7, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI), University of California, San Diego, Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT01873794
Brief Title
Treating Cancer-Related Fatigue Through Systematic Light Exposure
Official Title
Treating Cancer-Related Fatigue Through Systematic Light Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Cancer Institute (NCI), University of California, San Diego, Hackensack Meridian Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. There is currently no effective treatment for CRF. The purpose of this study is to investigate whether systematic exposure to light (from a commercially available Litebook) reduces CRF or other symptoms.
Detailed Description
Cancer related fatigue (CRF) - a persistent sense of exhaustion related to cancer or cancer treatment - can severely interfere with activities of daily living, and has even been reported to be a factor in patient requests for hastened death. CRF can represent a serious clinical problem years after all treatment has ended. In our research with cancer survivors 1 to 3 years after completion of hematopoietic stem cell transplant (HSCT), 40% of those we interviewed reported that CRF was a major obstacle to the resumption of usual activities. Despite its impact on quality of life, CRF is under-reported, under-diagnosed, and under-treated. A variety of pharmacologic agents have been studied to treat CRF, but there is insufficient evidence to recommend their use. The most promising non-pharmacologic interventions -- exercise and cognitive-behavior therapy (CBT) -- have shown equally modest effects. The proposed study focuses on a promising new intervention for CRF, using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box. Study collaborator, Ancoli-Israel and her colleagues have successfully piloted this line of research with breast cancer patients undergoing chemotherapy. The goal of this study will be to assess the effect of SLE on long-term HSCT and breast cancer survivors, and to determine the feasibility and acceptability of SLE as an intervention for CRF. The approach will be informed by the procedures that Ancoli-Israel and her colleagues developed for their research on SLE treatment for breast cancer chemotherapy, as well as by Redd's studies of CBT to treat adjustment disorders in survivors of HSCT. The study arms will test the efficacy of two different types of light treatment, bright white light and dim red light. Outcomes will be assessed through standardized measures of CRF, sleep quality, and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Stem Cell Transplantation, Breast Cancer, Fatigue, Mild Cognitive Impairment, Light, Quality of Life, Sleep
Keywords
Fatigue, Sleep, Quality of life, Cancer, Light

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright white light
Arm Type
Active Comparator
Arm Description
using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box
Arm Title
Dim red light
Arm Type
Active Comparator
Arm Description
using systematic light exposure (SLE), consisting of a daily 30-minute exposure to as much as 10,000 lux of light from a commercially available light box
Intervention Type
Device
Intervention Name(s)
Bright white light
Other Intervention Name(s)
Light Box, Litebook
Intervention Type
Device
Intervention Name(s)
Dim red light
Other Intervention Name(s)
Light Box, Litebook
Primary Outcome Measure Information:
Title
FACIT-Fatigue Scale
Description
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days. Measured at baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use
Time Frame
Baseline
Title
FACIT-Fatigue Scale
Description
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.
Time Frame
at 4 weeks
Title
FACIT-Fatigue Scale
Description
A list of statements that patients with cancer have said about their fatigue will be read. Subjects will mark on a 5-point scale how often they have felt each statement over the last 7 days.
Time Frame
at 3 months follow up
Secondary Outcome Measure Information:
Title
The Pittsburgh Sleep Quality Index
Description
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints). Baseline, second week of light box use, fourth (last) week of light box use, three weeks post completion of light box use
Time Frame
Baseline
Title
The Pittsburgh Sleep Quality Index
Description
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints).
Time Frame
at 4 weeks
Title
The Pittsburgh Sleep Quality Index
Description
The validity of the instrument is based on its ability to discriminate patients (those having either sleep problems and/or depressive symptoms) from controls (healthy participants without sleep complaints.
Time Frame
at 3 months follow up
Title
SF-36 Scale
Description
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
Time Frame
Baseline
Title
SF-36 Scale
Description
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
Time Frame
at 4 weeks
Title
SF-36 Scale
Description
Quality of life will be assessed using the SF-36 scale. The SF-36 is a multi-purpose, short form health survey consisting of 36 questions.
Time Frame
at 3 months follow up
Title
CNS-Vital Signs
Description
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
Time Frame
Baseline
Title
CNS-Vital Signs
Description
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
Time Frame
at 4 weeks
Title
CNS-Vital Signs
Description
Objective cognitive function will be assessed using CNS-Vital Signs, a reliable and valid computer-administered cognitive assessment battery that consists of 7 cognitive tests.
Time Frame
at 3 months follow up
Title
The Cognitive Failures Questionnaire
Description
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
Time Frame
Baseline
Title
The Cognitive Failures Questionnaire
Description
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
Time Frame
at 4 weeks
Title
The Cognitive Failures Questionnaire
Description
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
Time Frame
at 3 months follow up
Title
Brief Symptom Inventory-18
Description
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Time Frame
Baseline
Title
Brief Symptom Inventory-18
Description
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Time Frame
at 4 weeks
Title
Brief Symptom Inventory-18
Description
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Time Frame
at 3 months follow up
Title
Actiwatch Spectrum
Description
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Time Frame
Baseline
Title
Actiwatch Spectrum
Description
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Time Frame
at 4 weeks
Title
Actiwatch Spectrum
Description
Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Time Frame
at 3 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients: With a history of HSCT as treatment for hematological malignancies and related diseases and who are up to 3.5 years post-transplant; OR Who are up to three and a half years post completion of chemotherapy OR chemotherapy and radiation for breast cancer with a curative intent; AND: With a score equal to or less than 33 on the FACIT-Fatigue scale (see below) and no pre-existing anemia (Hb<10gm/dl); or a score equal to or greater than 43 on the Cognitive Failures Questionnaire Who are currently over age 18 and at least age 16 at the time of HSCT or time of breast cancer treatment Exclusion Criteria: Under age 18; Pregnancy; Confounding underlying medical illnesses; History of mania (which is a contra-indication for light treatment) or current clinical depression; And any other physical or psychological impairments including a sleep disorder diagnosis which would limit participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William H Redd, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29198295
Citation
Wu LM, Amidi A, Valdimarsdottir H, Ancoli-Israel S, Liu L, Winkel G, Byrne EE, Sefair AV, Vega A, Bovbjerg K, Redd WH. The Effect of Systematic Light Exposure on Sleep in a Mixed Group of Fatigued Cancer Survivors. J Clin Sleep Med. 2018 Jan 15;14(1):31-39. doi: 10.5664/jcsm.6874.
Results Reference
derived

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Treating Cancer-Related Fatigue Through Systematic Light Exposure

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