Treating Cancer-Related Fatigue Through Systematic Light Exposure

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT01873794

Collaborator

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

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation Breast Cancer Fatigue Mild Cognitive Impairment Light Quality of Life Sleep	Device: Bright white light Device: Dim red light	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Treating Cancer-Related Fatigue Through Systematic Light Exposure

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

FACIT-Fatigue Scale [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 [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 [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 Outcome Measures

The Pittsburgh Sleep Quality Index [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline]
A 25-item self-report measure of cognitive difficulties in everyday life using a 5-point Likert scale.
The Cognitive Failures Questionnaire [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 [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 [Baseline]
Used to assess psychological distress. A list of health problems and complaints that people sometimes experience are listed.
Brief Symptom Inventory-18 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.