The PC-LIGHT Study

Study Overview
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Brief Summary
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Fatigue due to cancer and its treatment (for example, radiation therapy) can interfere with quality of life and can linger long after treatment has ended, yet research examining preventative approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the prevention of fatigue in prostate cancer patients undergoing radiation therapy and will investigate how it works. This study would facilitate the development of this potential preventative treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related fatigue.

Official Title
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Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients

Conditions
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Prostate Cancer, Sleep, Depression, Fatigue, Quality of Life

Intervention / Treatment
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* Device: Intervention systematic light exposure
* Device: Comparison systematic light exposure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been diagnosed with clinical localized prostate cancer, Are about to begin external beam radiation therapy (RT) for prostate cancer, Are 18 years of age or older, Are able to speak or read English, Have internet access. Exclusion Criteria: History of light therapy use (e.g. systematic light exposure), Active infection History of chronic fatigue disorders Confounding underlying medical illnesses such as significant pre-existing anemia (Hb<10 gm/dl) Diagnosed or suspected psychiatric or medical condition that might contribute to fatigue (other than those caused by the cancer or its treatment) Hypothyroidism or documented history of hypothyroidism on thyroid replacement hormone within <3 months of initiating RT History of bipolar disorder or mania History of seasonal affective disorder Diagnosed sleep apnea, restless legs, or other sleep disorders (not including insomnia) known to affect fatigue Use of photosensitizing medication Plans to travel across more than 2 time zones during the study Shift worker Adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners will be excluded from the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention light<br>30 minutes of intervention systematic light exposure daily for the course of radiation therapy (approximately 8 weeks). | Device: Intervention systematic light exposure<br>* 30 minutes of intervention systematic light exposure daily<br>|
| Active Comparator: Comparison light<br>30 minutes of comparison systematic light exposure daily for the course of radiation therapy (approximately 8 weeks). | Device: Comparison systematic light exposure<br>* 30 minutes of comparison systematic light exposure daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue FACIT-Fatigue scores | FACIT-Fatigue scores | Baseline | 
| Fatigue | FACIT-Fatigue scores | Change from Baseline to the 4th week of the intervention | 
| Fatigue | FACIT-Fatigue scores | Change from Baseline to the 8th week of the intervention | 
| Fatigue | FACIT-Fatigue scores | Change from Baseline to 2 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circadian activity rhythms | Actigraphy | Baseline | 
| Circadian activity rhythms | Actigraphy | During the 4th week of the intervention | 
| Circadian activity rhythms | Actigraphy | During the 8th week of the intervention | 
| Circadian activity rhythms | Actigraphy | 2 months after the intervention | 
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | Baseline | 
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | During the 4th week of the intervention | 
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | During the 8th week of the intervention | 
| Sleep quality | Pittsburgh Sleep Quality Index (PSQI) | 2 months after the intervention | 
| Depressed mood | Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present. | Baseline | 
| Depressed mood | Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present. | During the 4th week of the intervention | 
| Depressed mood | Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present. | During the 8th week of the intervention | 
| Depressed mood | Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present. | 2 months after the intervention | 
| Cognitive Functioning | Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI) | Baseline | 
| Cognitive Functioning | Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI) | During the 4th week of the intervention | 
| Cognitive Functioning | Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI) | During the 8th week of the intervention | 
| Cognitive Functioning | Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI) | 2 months after the intervention | 
| Sexual and urinary functioning | 3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index | Baseline | 
| Sexual and urinary functioning | 3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index | During the 4th week of the intervention | 
| Sexual and urinary functioning | 3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index | During the 8th week of the intervention | 
| Sexual and urinary functioning | 3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index | 2 months after the intervention | 
| Cognitive functioning | Neuropsychological tests | Baseline | 
| Cognitive functioning | Neuropsychological tests | During the 8th week of the intervention | 
| Cognitive functioning | Neuropsychological tests | 2 months after the intervention | 
| Health-related quality of life | Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being.with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being. | Baseline | 
| Health-related quality of life | Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being. | During the 4th week of the intervention | 
| Health-related quality of life | Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being.with prostate cancer patients (1, 2, 3). It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being. | During the 8th week of the intervention | 
| Health-related quality of life | Functional Assessment of Cancer Therapy - Prostate (FACT-P). From Radiation Therapy Oncology Group: The FACT-P is a multidimensional, self-report QoL instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being.with prostate cancer patients (1, 2, 3). It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being. | 2 months after the intervention |