Back to resultsThe "PC-LIGHT" Study
Primary Purpose
Prostate Cancer, Sleep, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention systematic light exposure
Comparison systematic light exposure
Sponsored by
About this trial
This is an interventional prevention trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- Northwestern Univeristy Feinberg School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention light
Comparison light
Arm Description
30 minutes of intervention systematic light exposure daily for the course of radiation therapy (approximately 8 weeks).
30 minutes of comparison systematic light exposure daily for the course of radiation therapy (approximately 8 weeks).
Outcomes
Primary Outcome Measures
Fatigue FACIT-Fatigue scores
FACIT-Fatigue scores
Fatigue
FACIT-Fatigue scores
Fatigue
FACIT-Fatigue scores
Fatigue
FACIT-Fatigue scores
Secondary Outcome Measures
Circadian activity rhythms
Actigraphy
Circadian activity rhythms
Actigraphy
Circadian activity rhythms
Actigraphy
Circadian activity rhythms
Actigraphy
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Depressed mood
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Depressed mood
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Depressed mood
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Depressed mood
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Cognitive Functioning
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Cognitive Functioning
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Cognitive Functioning
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Cognitive Functioning
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Sexual and urinary functioning
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Sexual and urinary functioning
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Sexual and urinary functioning
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Sexual and urinary functioning
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Cognitive functioning
Neuropsychological tests
Cognitive functioning
Neuropsychological tests
Cognitive functioning
Neuropsychological tests
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.
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."
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.
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.
Full Information
NCT ID
NCT03419585
First Posted
January 24, 2018
Last Updated
March 22, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT03419585
Brief Title
The "PC-LIGHT" Study
Official Title
Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Sleep, Depression, Fatigue, Quality of Life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Participants will be randomized to one of two arms: an intervention light group or a comparison light group. Both the participant and the investigator will be blind to the light assignment.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention light
Arm Type
Experimental
Arm Description
30 minutes of intervention systematic light exposure daily for the course of radiation therapy (approximately 8 weeks).
Arm Title
Comparison light
Arm Type
Active Comparator
Arm Description
30 minutes of comparison systematic light exposure daily for the course of radiation therapy (approximately 8 weeks).
Intervention Type
Device
Intervention Name(s)
Intervention systematic light exposure
Intervention Description
30 minutes of intervention systematic light exposure daily
Intervention Type
Device
Intervention Name(s)
Comparison systematic light exposure
Intervention Description
30 minutes of comparison systematic light exposure daily
Primary Outcome Measure Information:
Title
Fatigue FACIT-Fatigue scores
Description
FACIT-Fatigue scores
Time Frame
Baseline
Title
Fatigue
Description
FACIT-Fatigue scores
Time Frame
Change from Baseline to the 4th week of the intervention
Title
Fatigue
Description
FACIT-Fatigue scores
Time Frame
Change from Baseline to the 8th week of the intervention
Title
Fatigue
Description
FACIT-Fatigue scores
Time Frame
Change from Baseline to 2 months after the intervention
Secondary Outcome Measure Information:
Title
Circadian activity rhythms
Description
Actigraphy
Time Frame
Baseline
Title
Circadian activity rhythms
Description
Actigraphy
Time Frame
During the 4th week of the intervention
Title
Circadian activity rhythms
Description
Actigraphy
Time Frame
During the 8th week of the intervention
Title
Circadian activity rhythms
Description
Actigraphy
Time Frame
2 months after the intervention
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
During the 4th week of the intervention
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
During the 8th week of the intervention
Title
Sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
2 months after the intervention
Title
Depressed mood
Description
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Time Frame
Baseline
Title
Depressed mood
Description
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Time Frame
During the 4th week of the intervention
Title
Depressed mood
Description
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Time Frame
During the 8th week of the intervention
Title
Depressed mood
Description
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Time Frame
2 months after the intervention
Title
Cognitive Functioning
Description
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Time Frame
Baseline
Title
Cognitive Functioning
Description
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Time Frame
During the 4th week of the intervention
Title
Cognitive Functioning
Description
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Time Frame
During the 8th week of the intervention
Title
Cognitive Functioning
Description
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Time Frame
2 months after the intervention
Title
Sexual and urinary functioning
Description
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Time Frame
Baseline
Title
Sexual and urinary functioning
Description
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Time Frame
During the 4th week of the intervention
Title
Sexual and urinary functioning
Description
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Time Frame
During the 8th week of the intervention
Title
Sexual and urinary functioning
Description
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Time Frame
2 months after the intervention
Title
Cognitive functioning
Description
Neuropsychological tests
Time Frame
Baseline
Title
Cognitive functioning
Description
Neuropsychological tests
Time Frame
During the 8th week of the intervention
Title
Cognitive functioning
Description
Neuropsychological tests
Time Frame
2 months after the intervention
Title
Health-related quality of life
Description
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.
Time Frame
Baseline
Title
Health-related quality of life
Description
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."
Time Frame
During the 4th week of the intervention
Title
Health-related quality of life
Description
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.
Time Frame
During the 8th week of the intervention
Title
Health-related quality of life
Description
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.
Time Frame
2 months after the intervention
Other Pre-specified Outcome Measures:
Title
Credibility/Expectancy
Description
Credibility/Expectancy questionnaire. There are two scales used during the questionnaire - (1-9, and 0-100%). A composite score can be calculated for each factor (expectancy and credibility).
Time Frame
Baseline
Title
Treatment satisfaction
Description
Functional Assessment of Cancer Therapy - Treatment Satisfaction - General (FACT-TS-G)
Time Frame
During the 8th week of the intervention
Title
Usage of light box
Description
integrated meter measurement and Litebook log. Length of time light box has been used.
Time Frame
Throughout intervention period (8 weeks)
Title
Chronotype
Description
Morningness-eveningness questionnaire. From the item itself: "Scores can range from 4-25. Scores of 7 and below indicate "evening types." Scores of 22 and above indicate "morning types." Scores between 8-21 indicate "intermediate types."
Time Frame
Baseline
Title
BMI
Description
BMI table
Time Frame
Baseline
Title
Physical health
Description
Goldin Leisure Time Exercise Questionnaire. From the measure itself: " For the first question, weekly frequencies of strenuous, moderate, and light activities are multiplied by nine, five, and three, respectively. Total weekly leisure activity is calculated in arbitrary units by summing the products of the separate components, as shown in the following formula: Weekly leisure activity score = (9 × Strenuous) + (5 × Moderate) + (3 × Light) The second question is used to calculate the frequency of weekly leisure-time activities pursued "long enough to work up a sweat" (see questionnaire)."
Time Frame
Baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa M Wu, PhD
Phone
(312)503-2762
Email
lisa.wu1@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Wu, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Univeristy Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa M Wu, PhD
Phone
312-503-2762
Email
lisa.wu1@northwestern.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The "PC-LIGHT" Study
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