The "PC-LIGHT" Study

Depression Clinical Trial

Official title:

Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419585
• Other study ID #: STU00205260
• Status: Completed
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Fatigue
• Prostate Cancer
• Prostatic Neoplasms
• Quality of Life
• Sleep

Intervention

Device:
• Intervention systematic light exposure
30 minutes of intervention systematic light exposure daily
• Comparison systematic light exposure
30 minutes of comparison systematic light exposure daily

Locations

Country	Name	City	State
United States	Northwestern Univeristy Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Treatment satisfaction	Functional Assessment of Cancer Therapy - Treatment Satisfaction - General (FACT-TS-G)	During the 8th week of the intervention
Other	Usage of light box	integrated meter measurement and Litebook log. Length of time light box has been used.	Throughout intervention period (8 weeks)
Other	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
Other	BMI	BMI table	Baseline
Other	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
Primary	Fatigue FACIT-Fatigue scores	FACIT-Fatigue scores	Baseline
Primary	Fatigue	FACIT-Fatigue scores	Change from Baseline to the 4th week of the intervention
Primary	Fatigue	FACIT-Fatigue scores	Change from Baseline to the 8th week of the intervention
Primary	Fatigue	FACIT-Fatigue scores	Change from Baseline to 2 months after the intervention
Secondary	Circadian activity rhythms	Actigraphy	Baseline
Secondary	Circadian activity rhythms	Actigraphy	During the 4th week of the intervention
Secondary	Circadian activity rhythms	Actigraphy	During the 8th week of the intervention
Secondary	Circadian activity rhythms	Actigraphy	2 months after the intervention
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	Baseline
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	During the 4th week of the intervention
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	During the 8th week of the intervention
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	2 months after the intervention
Secondary	Depressed mood	Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Cognitive Functioning	Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)	Baseline
Secondary	Cognitive Functioning	Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)	During the 4th week of the intervention
Secondary	Cognitive Functioning	Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)	During the 8th week of the intervention
Secondary	Cognitive Functioning	Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)	2 months after the intervention
Secondary	Sexual and urinary functioning	3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	Cognitive functioning	Neuropsychological tests	Baseline
Secondary	Cognitive functioning	Neuropsychological tests	During the 8th week of the intervention
Secondary	Cognitive functioning	Neuropsychological tests	2 months after the intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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