Treating Cancer-Related Fatigue Through Systematic Light Exposure
3 other identifiers
interventional
54
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2013
CompletedFirst Posted
Study publicly available on registry
June 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedApril 11, 2017
April 1, 2017
2.5 years
June 6, 2013
April 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
FACIT-Fatigue Scale
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
Baseline
FACIT-Fatigue Scale
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.
at 4 weeks
FACIT-Fatigue Scale
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.
at 3 months follow up
Secondary Outcomes (18)
The Pittsburgh Sleep Quality Index
Baseline
The Pittsburgh Sleep Quality Index
at 4 weeks
The Pittsburgh Sleep Quality Index
at 3 months follow up
SF-36 Scale
Baseline
SF-36 Scale
at 4 weeks
- +13 more secondary outcomes
Study Arms (2)
Bright white light
ACTIVE COMPARATORusing 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
Dim red light
ACTIVE COMPARATORusing 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- National Cancer Institute (NCI)collaborator
- University of California, San Diegocollaborator
- Hackensack Meridian Healthcollaborator
Study Sites (2)
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Related Publications (1)
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.
PMID: 29198295DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William H Redd, PhD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2013
First Posted
June 10, 2013
Study Start
January 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
April 11, 2017
Record last verified: 2017-04