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.
Study Type
OBSERVATIONAL
Enrollment
124
Aarhus University Hospital
Aarhus, Denmark
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to time 2 (an average of 1 month)
Circadian Activity Rhythms change
Rest/wake activity recorded with wrist actigraphy
Time frame: Change from baseline to time 3 (an average of 6 months)
Circadian Activity Rhythms change
Rest/wake activity recorded with wrist actigraphy
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Circadian skin temperature change
Distal skin temperature recorded with wrist actigraphy
Time frame: Change from baseline to time 2 (an average of 1 month)
Circadian skin temperature change
Distal skin temperature recorded with wrist actigraphy
Time frame: Change from baseline to time 3 (an average of 6 months)
Circadian skin temperature change
Distal skin temperature recorded with wrist actigraphy
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Dim light melatonin onset change
Melatonin based on saliva samples
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Cognitive functioning change
Standard neuropsychological test battery
Time frame: Change from baseline to time 3 (an average of 6 months)
Cognitive functioning change
Standard neuropsychological test battery
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Cancer-related fatigue change
FACIT fatigue
Time frame: Change from baseline to time 2 (an average of 1 month)
Cancer-related fatigue change
FACIT fatigue
Time frame: Change from baseline to time 3 (an average of 6 months)
Cancer-related fatigue change
FACIT fatigue
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Sleep change
Objective sleep recorded with wrist actigraphy
Time frame: Change from baseline to time 2 (an average of 1 month)
Sleep change
Objective sleep recorded with wrist actigraphy
Time frame: Change from baseline to time 3 (an average of 6 months)
Sleep change
Objective sleep recorded with wrist actigraphy
Time frame: 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.
Time frame: Change from baseline to time 3 (an average of 6 months)
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Inflammatory markers change
Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples.
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Stress change
Perceived Stress Scale (PSS)
Time frame: Change from baseline to time 2 (an average of 1 month)
Stress change
PSS
Time frame: Change from baseline to time 3 (an average of 6 months)
Stress change
PSS
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Sleep quality change
Pittsburgh sleep quality index
Time frame: Change from baseline to time 2 (an average of 1 month)
Sleep quality change
Pittsburgh sleep quality index
Time frame: Change from baseline to time 3 (an average of 6 months)
Sleep quality change
Pittsburgh sleep quality index
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Insomnia change
Insomnia Severity Index
Time frame: Change from baseline to time 2 (an average of 1 month)
Insomnia change
Insomnia Severity Index
Time frame: Change from baseline to time 3 (an average of 6 months)
Insomnia change
Insomnia Severity Index
Time frame: 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)
Time frame: Change from baseline to time 2 (an average of 1 month)
Self-reported cognitive functioning change
FACT-Cog
Time frame: Change from baseline to time 3 (an average of 6 months)
Self-reported cognitive functioning change
FACT-Cog
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Depression change
Center for Epidemiologic Studies Depression Scale (CESD)
Time frame: Change from baseline to time 2 (an average of 1 month)
Depression change
CESD
Time frame: Change from baseline to time 3 (an average of 6 months)
Depression change
CESD
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)
Self-reported quality of life change
Short Form 36 (SF36)
Time frame: Change from baseline to time 2 (an average of 1 month)
Self-reported quality of life change
SF36
Time frame: Change from baseline to time 3 (an average of 6 months)
Self-reported quality of life change
SF36
Time frame: Change from baseline to time 4 (through study completion, an average of 1 year)