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Treating Cancer-Related Fatigue Through Systematic Light Exposure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01873794
First Posted: June 10, 2013
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
University of California, San Diego
Hackensack University Medical Center
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
June 6, 2013
June 10, 2013
April 11, 2017
January 2012
July 2014   (Final data collection date for primary outcome measure)
  • FACIT-Fatigue Scale [ Time Frame: Baseline ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 3 months follow up ]
    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 [ Time Frame: Baseline ]
    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 [ Time Frame: at 2 weeks ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 7 weeks ]
    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.
Complete list of historical versions of study NCT01873794 on ClinicalTrials.gov Archive Site
  • The Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 3 months follow up ]
    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 [ Time Frame: Baseline ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 3 months follow up ]
    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 [ Time Frame: Baseline ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 3 months follow up ]
    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 [ Time Frame: Baseline ]
    A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
  • The Cognitive Failures Questionnaire [ Time Frame: at 4 weeks ]
    A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
  • The Cognitive Failures Questionnaire [ Time Frame: at 3 months follow up ]
    A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
  • Brief Symptom Inventory-18 [ Time Frame: Baseline ]
    Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
  • Brief Symptom Inventory-18 [ Time Frame: at 4 weeks ]
    Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
  • Brief Symptom Inventory-18 [ Time Frame: at 3 months follow up ]
    Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
  • Actiwatch Spectrum [ Time Frame: Baseline ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 3 months follow up ]
    Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
  • The Pittsburgh Sleep Quality Index [ Time Frame: Baseline ]
    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 [ Time Frame: at 2 weeks ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 7 weeks ]
    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 [ Time Frame: Baseline ]
    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 [ Time Frame: at 2 weeks ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 7 weeks ]
    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 [ Time Frame: Baseline ]
    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 [ Time Frame: at 2 weeks ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 7 weeks ]
    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 [ Time Frame: Baseline ]
    A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
  • The Cognitive Failures Questionnaire [ Time Frame: at 4 weeks ]
    A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
  • The Cognitive Failures Questionnaire [ Time Frame: at 7 weeks ]
    A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
  • Brief Symptom Inventory-18 [ Time Frame: Baseline ]
    Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
  • Brief Symptom Inventory-18 [ Time Frame: at 4 weeks ]
    Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
  • Brief Symptom Inventory-18 [ Time Frame: at 7 weeks ]
    Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
  • Actiwatch Spectrum [ Time Frame: Baseline ]
    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 [ Time Frame: at 2 weeks ]
    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 [ Time Frame: at 4 weeks ]
    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 [ Time Frame: at 7 weeks ]
    Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.
Not Provided
Not Provided
 
Treating Cancer-Related Fatigue Through Systematic Light Exposure
Treating Cancer-Related Fatigue Through Systematic Light Exposure
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
  • Hematopoietic Stem Cell Transplantation
  • Breast Cancer
  • Fatigue
  • Mild Cognitive Impairment
  • Light
  • Quality of Life
  • Sleep
  • Device: Bright white light
    Other Names:
    • Light Box
    • Litebook
  • Device: Dim red light
    Other Names:
    • Light Box
    • Litebook
  • Active Comparator: Bright white light
    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: Device: Bright white light
  • Active Comparator: Dim red light
    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: Device: Dim red light
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
July 2014
July 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01873794
GCO 10-0864
5R21CA158954 ( U.S. NIH Grant/Contract )
HSM#11-01032
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
  • National Cancer Institute (NCI)
  • University of California, San Diego
  • Hackensack University Medical Center
Principal Investigator: William H Redd, PhD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP