The "PC-LIGHT" Study

Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Fatigue; Sleep; Prostate Cancer
• Intervention / Treatment: Device: Intervention systematic light exposure; Device: Comparison systematic light exposure

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univeristy Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Credibility/Expectancy	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).	Baseline
Treatment satisfaction	Functional Assessment of Cancer Therapy - Treatment Satisfaction - General (FACT-TS-G)	During the 8th week of the intervention
Usage of light box	integrated meter measurement and Litebook log. Length of time light box has been used.	Throughout intervention period (8 weeks)
Chronotype	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."	Baseline
BMI	BMI table	Baseline
Physical health	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)."	Baseline

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Lisa M Wu, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Fatigue; Prostatic Neoplasms
• Other Study ID Numbers: STU00205260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No