Breast Cancer, Cancer-Related Syndrome, Circadian Rhythm Disorders, Cognitive Impairment, Depression, Fatigue, Inflammation, Quality of Life, Sleep, Stress, Psychological
Conditions
Keywords
Breast cancer, Circadian rhythms disruption, Cancer-related symptoms
Brief summary
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.
Interventions
None listed
Sponsors
University of Aarhus
Danish Cancer Society
Aarhus University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with early breast cancer scheduled for surgery and chemotherapy (neoadjuvant or adjuvant) at Aarhus University Hospital (AUH). * The healthy control group will consist of an age-matched sample of participants with no history of cancer.
Exclusion criteria
* Pregnancy * Shift-work * Melatonin supplementation * Insufficient Danish proficiency * Previous cancer diagnosis except for treated non-melanoma skin cancer * Confounding diagnosed or suspected psychiatric or medical conditions that might significantly contribute to the CRS or symptoms/diagnoses resembling them (other than those caused by cancer or its treatment) such as seasonal affective disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer related symptoms composite score change | Change from baseline to time 2 (an average of 1 month) | A composite score will be calculated based on measures of fatigue, sleep, cognition, and depression as described under secondary outcomes |
| Circadian Activity Rhythms change | Change from baseline to time 2 (an average of 1 month) | Rest/wake activity recorded with wrist actigraphy |
| Circadian skin temperature change | Change from baseline to time 2 (an average of 1 month) | Distal skin temperature recorded with wrist actigraphy |
| Dim light melatonin onset change | Change from baseline to time 4 (through study completion, an average of 1 year) | Melatonin based on saliva samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stress change | Change from baseline to time 2 (an average of 1 month) | Perceived Stress Scale (PSS) |
| Sleep quality change | Change from baseline to time 2 (an average of 1 month) | Pittsburgh sleep quality index |
| Insomnia change | Change from baseline to time 2 (an average of 1 month) | Insomnia Severity Index |
| Cognitive functioning change | Change from baseline to time 3 (an average of 6 months) | Standard neuropsychological test battery |
| Depression change | Change from baseline to time 2 (an average of 1 month) | Center for Epidemiologic Studies Depression Scale (CESD) |
| Self-reported quality of life change | Change from baseline to time 2 (an average of 1 month) | Short Form 36 (SF36) |
| Self-reported cognitive functioning change | Change from baseline to time 2 (an average of 1 month) | Functional Assessment of Cancer Therapy - Cognitive function issues (FACT-Cog) |
| Cancer-related fatigue change | Change from baseline to time 2 (an average of 1 month) | FACIT fatigue |
| Sleep change | Change from baseline to time 2 (an average of 1 month) | Objective sleep recorded with wrist actigraphy |
| Inflammatory markers change | Change from baseline to time 3 (an average of 6 months) | Proinflammatory cytokines known to mediate chronic inflammatory processes. Extracted from blood samples. |
Countries
Denmark
Outcome results
None listed