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Treating Cancer-Related Fatigue Through Systematic Light Exposure

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ClinicalTrials.gov Identifier: NCT01873794
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : April 11, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, San Diego
Hackensack Meridian Health
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE June 6, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date April 11, 2017
Study Start Date  ICMJE January 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2013)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treating Cancer-Related Fatigue Through Systematic Light Exposure
Official Title  ICMJE Treating Cancer-Related Fatigue Through Systematic Light Exposure
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Hematopoietic Stem Cell Transplantation
  • Breast Cancer
  • Fatigue
  • Mild Cognitive Impairment
  • Light
  • Quality of Life
  • Sleep
Intervention  ICMJE
  • Device: Bright white light
    Other Names:
    • Light Box
    • Litebook
  • Device: Dim red light
    Other Names:
    • Light Box
    • Litebook
Study Arms  ICMJE
  • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2016)
54
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2013)
75
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873794
Other Study ID Numbers  ICMJE GCO 10-0864
5R21CA158954 ( U.S. NIH Grant/Contract )
HSM#11-01032
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • University of California, San Diego
  • Hackensack Meridian Health
Investigators  ICMJE
Principal Investigator: William H Redd, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2017

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