Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Depressive Disorder

Fatigue

Prostatic Neoplasms

Depression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

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).

30 minutes of intervention systematic light exposure daily

Intervention systematic light exposure

30 minutes of comparison systematic light exposure daily

Comparison systematic light exposure

Lisa M Wu, PhD

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.

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.

The "PC-LIGHT" Study

Systematic Light Exposure to Prevent Fatigue in Prostate Cancer Patients

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).

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

integrated meter measurement and Litebook log. Length of time light box has been used.

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."

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)."

Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present.

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

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

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.

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."

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.

Northwestern University

Assistant Professor

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

30 minutes of intervention systematic light exposure daily for 4 weeks.

30 minutes of comparison systematic light exposure daily for 4 weeks.

Dim light using modified Litebook device.

Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.

The "Light for the Brain" Study

Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure

Range between 0 and 5, with 5 meaning higher treatment satisfaction

Treatment credibility and outcome expectancy were assessed at baseline with the mean of the first 3 items of the Credibility/Expectancy Questionnaire. Items are scored on a Likert scale from 1 to 9, and the term "symptoms" was replaced with "thinking, memory and concentration problems." Higher scores represent greater credibility and outcome expectancy.

Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.

Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III.

Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores.

A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.

F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.

The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality

The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week.

Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.

This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).

The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored "1" indicating impairment, and ratings from 4 to 6 were scored "0" indicating no impairment. Total impairment was calculated by summing the number of impaired items.

National Cancer Institute (NCI)

30 minutes of intervention systematic light exposure daily for 4 weeks.

Intervention systematic light exposure: Bright light using Litebook device.

Intervention Light

30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks.

Comparison systematic light exposure: Dim light using modified Litebook device.

Comparison Light

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Baseline estimate of premorbid intellectual functioning; The WTAR (Wechsler, 2001) comprises 50 words with irregular pronunciations that participants read aloud. The raw score ranges from 0 to 50, with a higher score indicating better performance, and the raw score can be transformed to an age-adjusted standard score, which is used to predict IQ (M = 100; SD = 15).

Wechsler Test of Adult Reading

Lisa M. Wu, Ph.D.

End of intervention

8 weeks after intervention

Cognitive Functioning (Neuropsychological Tests)

Baseline

Circadian Activity Rhythms (Actigraphy)

Mid-treatment

End of treatment

8 weeks later

30 minutes of comparison systematic light exposure daily for 4 weeks.

Comparison systematic light exposure: Dim light using modified Litebook device.

Sleep Quality (Pittsburgh Sleep Quality Index)

Mid-intervention

8 weeks post-intervention

Fatigue (FACIT-fatigue)

8 weeks post intervention

Depressed Mood (CESD)

End-of-intervention

Participants did not always complete this measure, which accounts for why there are sometimes fewer participants than the overall number of participants analyzed at different time points. Linear mixed models allows for missing time points.

Neurobehavioral Functioning (Frontal Systems Behavioral Scale)

Quality of Life (FACT-BMT)

Interleukin-6

Two participants did not provide blood samples at the end-of-intervention

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The "PC-LIGHT" Study	NCT03419585	Prostate Cancer Sleep Depression Fatigue Quality of Life	Intervention sy... Comparison syst...	18 Years -	Northwestern University
The "Light for the Brain" Study	NCT02677987	Hematopoietic S... Cognitive Impai... Sleep Depression Fatigue Quality of Life	Intervention sy... Comparison syst...	21 Years -	Northwestern University
The "Light for the Brain" Study	NCT02677987	Hematopoietic S... Cognitive Impai... Sleep Depression Fatigue Quality of Life	Intervention sy... Comparison syst...	21 Years -	Northwestern University
The "PC-LIGHT" Study	NCT03419585	Prostate Cancer Sleep Depression Fatigue Quality of Life	Intervention sy... Comparison syst...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for intervention systematic light exposure