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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
| Danish Cancer Society | OTHER |
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Emerging evidence indicates that circadian rhythms may be disrupted following cancer and its treatment, and that circadian rhythm disruption may be an underlying pathophysiological mechanism of cancer- and cancer treatment-related symptoms (CRS) such as fatigue, sleep disturbance, cognitive impairment, and depressed mood. Given the detrimental effect of CRS on cancer survivors' quality of life, and a pressing demand for effective interventions to treat CRS, there is a need for a comprehensive examination of circadian disruption related to cancer and its treatment, and its association with CRS. The study will prospectively examine circadian rhythms and a CRS composite score in recently diagnosed breast cancer patients from prior to surgery or chemotherapy to 12 months later. A matched healthy control group will serve as a comparison.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer patients | |||
| Healthy controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Cancer related symptoms composite score change | A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes | Change from baseline to time 2 (an average of 1 month) |
| Cancer related symptoms composite score change | A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes | Change from baseline to time 3 (an average of 6 months) |
| Cancer related symptoms composite score change | A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Circadian Activity Rhythms change | Rest/wake activity recorded with wrist actigraphy | Change from baseline to time 2 (an average of 1 month) |
| Circadian Activity Rhythms change | Rest/wake activity recorded with wrist actigraphy | Change from baseline to time 3 (an average of 6 months) |
| Circadian Activity Rhythms change | Rest/wake activity recorded with wrist actigraphy | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Circadian skin temperature change |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive functioning change | Standard neuropsychological test battery | Change from baseline to time 3 (an average of 6 months) |
| Cognitive functioning change | Standard neuropsychological test battery |
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Inclusion Criteria:
Exclusion Criteria:
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Newly diagnosed breast cancer patients. Controls will be healthy volunteers of cancer-free women matched on age.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| D013315 | Stress, Psychological |
| D007249 | Inflammation |
| D021081 | Chronobiology Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Saliva samples for melatonin. Blood samples for inflammatory cytokines.
Distal skin temperature recorded with wrist actigraphy
| Change from baseline to time 2 (an average of 1 month) |
| Circadian skin temperature change | Distal skin temperature recorded with wrist actigraphy | Change from baseline to time 3 (an average of 6 months) |
| Circadian skin temperature change | Distal skin temperature recorded with wrist actigraphy | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Dim light melatonin onset change | Melatonin based on saliva samples | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Change from baseline to time 4 (through study completion, an average of 1 year) |
| Cancer-related fatigue change | FACIT fatigue | Change from baseline to time 2 (an average of 1 month) |
| Cancer-related fatigue change | FACIT fatigue | Change from baseline to time 3 (an average of 6 months) |
| Cancer-related fatigue change | FACIT fatigue | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Sleep change | Objective sleep recorded with wrist actigraphy | Change from baseline to time 2 (an average of 1 month) |
| Sleep change | Objective sleep recorded with wrist actigraphy | Change from baseline to time 3 (an average of 6 months) |
| Sleep change | Objective sleep recorded with wrist actigraphy | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Inflammatory markers change | Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples. | Change from baseline to time 3 (an average of 6 months) |
| Inflammatory markers change | Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples. | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Stress change | Perceived Stress Scale (PSS) | Change from baseline to time 2 (an average of 1 month) |
| Stress change | PSS | Change from baseline to time 3 (an average of 6 months) |
| Stress change | PSS | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Sleep quality change | Pittsburgh sleep quality index | Change from baseline to time 2 (an average of 1 month) |
| Sleep quality change | Pittsburgh sleep quality index | Change from baseline to time 3 (an average of 6 months) |
| Sleep quality change | Pittsburgh sleep quality index | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Insomnia change | Insomnia Severity Index | Change from baseline to time 2 (an average of 1 month) |
| Insomnia change | Insomnia Severity Index | Change from baseline to time 3 (an average of 6 months) |
| Insomnia change | Insomnia Severity Index | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Self-reported cognitive functioning change | Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog) | Change from baseline to time 2 (an average of 1 month) |
| Self-reported cognitive functioning change | FACT-Cog | Change from baseline to time 3 (an average of 6 months) |
| Self-reported cognitive functioning change | FACT-Cog | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Depression change | Center for Epidemiologic Studies Depression Scale (CESD) | Change from baseline to time 2 (an average of 1 month) |
| Depression change | CESD | Change from baseline to time 3 (an average of 6 months) |
| Depression change | CESD | Change from baseline to time 4 (through study completion, an average of 1 year) |
| Self-reported quality of life change | Short Form 36 (SF36) | Change from baseline to time 2 (an average of 1 month) |
| Self-reported quality of life change | SF36 | Change from baseline to time 3 (an average of 6 months) |
| Self-reported quality of life change | SF36 | Change from baseline to time 4 (through study completion, an average of 1 year) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D009422 | Nervous System Diseases |