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Completed

NCT Number: NCT01873794

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation Breast Cancer Breast Diseases Breast Neoplasms Cognition Disorders Cognitive Dysfunction Fatigue Light Mental Disorders Mild Cognitive Impairment Neoplasms Neoplasms by Site Neurocognitive Disorders Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack University Medical Center, Hackensack, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bright white light

Device

Other names: Light Box, Litebook

Dim red light

Device

Other names: Light Box, Litebook

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Hackensack Meridian Health
  • National Cancer Institute (NCI)
  • University of California, San Diego

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2013
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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