Trial record 19 of 269 for:    Open Studies | "Fatigue"

Treating Cancer-Related Fatigue Through Systematic Light Exposure

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Mount Sinai School of Medicine
Sponsor:
Collaborators:
University of California, San Diego
Hackensack University Medical Center
Information provided by (Responsible Party):
William H. Redd, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01873794
First received: June 6, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Hematopoietic Stem Cell Transplantation
Breast Cancer
Fatigue
Mild Cognitive Impairment
Light
Quality of Life
Sleep
Device: Bright white light
Device: Dim red light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Treating Cancer-Related Fatigue Through Systematic Light Exposure

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • FACIT-Fatigue Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.

  • Actiwatch Spectrum [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Sleep/wake activity is measured using an actigraph which records physical movement and detects light. The Actiwatch is worn for 72 consecutive hours.


Estimated Enrollment: 75
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: Bright white light
Other Names:
  • Light Box
  • Litebook
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
Device: Dim red light
Other Names:
  • Light Box
  • Litebook

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873794

Contacts
Contact: Elizabeth Chu 212-659-5525 elizabeth.chu@mssm.edu

Locations
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Emily Brown, RN, BSN, CHPN    551-996-3923    EmilyBrown@HackensackUMC.org   
Principal Investigator: Scott Rowley, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Elizabeth Chu    212-659-5525    elizabeth.chu@mssm.edu   
Principal Investigator: William H Redd, PhD         
Sponsors and Collaborators
Mount Sinai School of Medicine
University of California, San Diego
Hackensack University Medical Center
Investigators
Principal Investigator: William H Redd, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: William H. Redd, Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01873794     History of Changes
Other Study ID Numbers: GCO 10-0864, 5R21CA158954, HSM#11-01032
Study First Received: June 6, 2013
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Fatigue
Sleep
Quality of life
Cancer
Light

Additional relevant MeSH terms:
Fatigue
Breast Neoplasms
Cognition Disorders
Mild Cognitive Impairment
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014