Depression, Fatigue, Prostate Cancer, Quality of Life, Sleep
Conditions
Brief 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.
Interventions
30 minutes of intervention systematic light exposure daily
30 minutes of comparison systematic light exposure daily
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue FACIT-Fatigue scores | Baseline | FACIT-Fatigue scores |
| Fatigue | Change from Baseline to the 4th week of the intervention | FACIT-Fatigue scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circadian activity rhythms | Baseline | Actigraphy |
| Cognitive Functioning | Baseline | Psychometric Analysis of the Patient Assessment of Own Functioning Inventory (PAOFI) |
| Sleep quality | Baseline | Pittsburgh Sleep Quality Index (PSQI) |
| Depressed mood | Baseline | Center for Epidemiologic Studies Depression Scale (CESD). Score range is 0 to 60, where higher scores represent more symptomatology present. |
| Sexual and urinary functioning | Baseline | 3 items from the Sexual Adjustment Questionnaire & 3 items from American Urological Association (AUA) symptom index |
| Cognitive functioning | Baseline | Neuropsychological tests |
| Health-related quality of life | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chronotype | 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. |
| BMI | Baseline | BMI table |
| Physical health | 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). |
| Usage of light box | Throughout intervention period (8 weeks) | integrated meter measurement and Litebook log. Length of time light box has been used. |
| Credibility/Expectancy | 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). |
| Treatment satisfaction | During the 8th week of the intervention | Functional Assessment of Cancer Therapy - Treatment Satisfaction - General (FACT-TS-G) |
Countries
United States
Outcome results
None listed