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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention light | Experimental | 30 minutes of intervention systematic light exposure daily for the course of radiation therapy (approximately 8 weeks). |
|
| Comparison light | Active Comparator | 30 minutes of comparison systematic light exposure daily for the course of radiation therapy (approximately 8 weeks). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention systematic light exposure | Device | 30 minutes of intervention systematic light exposure daily |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian activity rhythms | Actigraphy | Baseline |
| Circadian activity rhythms | Actigraphy | During the 4th week of the intervention |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Wu, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Univeristy Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
| Comparison systematic light exposure | Device | 30 minutes of comparison systematic light exposure daily |
|
| 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 |
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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |