The "PC-LIGHT" Study

March 21, 2024 updated by: Lisa M. Wu, Northwestern University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue FACIT-Fatigue scores
Time Frame: Baseline
FACIT-Fatigue scores
Baseline
Fatigue
Time Frame: Change from Baseline to the 4th week of the intervention
FACIT-Fatigue scores
Change from Baseline to the 4th week of the intervention
Fatigue
Time Frame: Change from Baseline to the 8th week of the intervention
FACIT-Fatigue scores
Change from Baseline to the 8th week of the intervention
Fatigue
Time Frame: Change from Baseline to 2 months after the intervention
FACIT-Fatigue scores
Change from Baseline to 2 months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Circadian activity rhythms
Time Frame: Baseline
Actigraphy
Baseline
Circadian activity rhythms
Time Frame: During the 4th week of the intervention
Actigraphy
During the 4th week of the intervention
Circadian activity rhythms
Time Frame: During the 8th week of the intervention
Actigraphy
During the 8th week of the intervention
Circadian activity rhythms
Time Frame: 2 months after the intervention
Actigraphy
2 months after the intervention
Sleep quality
Time Frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Baseline
Sleep quality
Time Frame: During the 4th week of the intervention
Pittsburgh Sleep Quality Index (PSQI)
During the 4th week of the intervention
Sleep quality
Time Frame: During the 8th week of the intervention
Pittsburgh Sleep Quality Index (PSQI)
During the 8th week of the intervention
Sleep quality
Time Frame: 2 months after the intervention
Pittsburgh Sleep Quality Index (PSQI)
2 months after the intervention
Depressed mood
Time Frame: Baseline
Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.
Baseline
Depressed mood
Time Frame: During the 4th week of the intervention
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
Time Frame: During the 8th week of the intervention
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
Time Frame: 2 months after the intervention
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
Time Frame: Baseline
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
Baseline
Cognitive Functioning
Time Frame: During the 4th week of the intervention
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
During the 4th week of the intervention
Cognitive Functioning
Time Frame: During the 8th week of the intervention
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
During the 8th week of the intervention
Cognitive Functioning
Time Frame: 2 months after the intervention
Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)
2 months after the intervention
Sexual and urinary functioning
Time Frame: Baseline
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
Baseline
Sexual and urinary functioning
Time Frame: During the 4th week of the intervention
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
Time Frame: During the 8th week of the intervention
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
Time Frame: 2 months after the intervention
3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index
2 months after the intervention
Cognitive functioning
Time Frame: Baseline
Neuropsychological tests
Baseline
Cognitive functioning
Time Frame: During the 8th week of the intervention
Neuropsychological tests
During the 8th week of the intervention
Cognitive functioning
Time Frame: 2 months after the intervention
Neuropsychological tests
2 months after the intervention
Health-related quality of life
Time Frame: Baseline
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
Time Frame: During the 4th week of the intervention
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
Time Frame: During the 8th week of the intervention
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
Time Frame: 2 months after the intervention
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Credibility/Expectancy
Time Frame: Baseline
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
Time Frame: During the 8th week of the intervention
Functional Assessment of Cancer Therapy - Treatment Satisfaction - General (FACT-TS-G)
During the 8th week of the intervention
Usage of light box
Time Frame: Throughout intervention period (8 weeks)
integrated meter measurement and Litebook log. Length of time light box has been used.
Throughout intervention period (8 weeks)
Chronotype
Time Frame: Baseline
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
Time Frame: Baseline
BMI table
Baseline
Physical health
Time Frame: Baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa M Wu, PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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