Skip to main content
OpenTrials
Completed

NCT Number: NCT03419585

The "PC-LIGHT" Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Behavior Behavioral Symptoms Depression Fatigue Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Quality of Life Signs and Symptoms Sleep Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Univeristy Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention systematic light exposure

Device

30 minutes of intervention systematic light exposure daily

Comparison systematic light exposure

Device

30 minutes of comparison systematic light exposure daily

Primary outcomes

  1. Fatigue FACIT-Fatigue scores

    Time frame: Baseline

    FACIT-Fatigue scores

  2. Fatigue

    Time frame: Change from Baseline to the 4th week of the intervention

    FACIT-Fatigue scores

  3. Fatigue

    Time frame: Change from Baseline to the 8th week of the intervention

    FACIT-Fatigue scores

  4. Fatigue

    Time frame: Change from Baseline to 2 months after the intervention

    FACIT-Fatigue scores

Secondary outcomes

  1. Circadian activity rhythms

    Time frame: Baseline

    Actigraphy

  2. Circadian activity rhythms

    Time frame: During the 4th week of the intervention

    Actigraphy

  3. Circadian activity rhythms

    Time frame: During the 8th week of the intervention

    Actigraphy

  4. Circadian activity rhythms

    Time frame: 2 months after the intervention

    Actigraphy

  5. Sleep quality

    Time frame: Baseline

    Pittsburgh Sleep Quality Index (PSQI)

  6. Sleep quality

    Time frame: During the 4th week of the intervention

    Pittsburgh Sleep Quality Index (PSQI)

  7. Sleep quality

    Time frame: During the 8th week of the intervention

    Pittsburgh Sleep Quality Index (PSQI)

  8. Sleep quality

    Time frame: 2 months after the intervention

    Pittsburgh Sleep Quality Index (PSQI)

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Cognitive Functioning

    Time frame: Baseline

    Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)

  14. Cognitive Functioning

    Time frame: During the 4th week of the intervention

    Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)

  15. Cognitive Functioning

    Time frame: During the 8th week of the intervention

    Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)

  16. Cognitive Functioning

    Time frame: 2 months after the intervention

    Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI)

  17. Sexual and urinary functioning

    Time frame: Baseline

    3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index

  18. 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

  19. 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

  20. 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

  21. Cognitive functioning

    Time frame: Baseline

    Neuropsychological tests

  22. Cognitive functioning

    Time frame: During the 8th week of the intervention

    Neuropsychological tests

  23. Cognitive functioning

    Time frame: 2 months after the intervention

    Neuropsychological tests

  24. 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.

  25. 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."

  26. 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.

  27. 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.

Other outcomes

  1. 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).

  2. Treatment satisfaction

    Time frame: During the 8th week of the intervention

    Functional Assessment of Cancer Therapy - Treatment Satisfaction - General (FACT-TS-G)

  3. 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.

  4. 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."

  5. BMI

    Time frame: Baseline

    BMI table

  6. 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)."

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2018
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.