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The purpose of this study is to explore the possible association between the circadian disruption and cancer progression.
The biological markers that are assumed to bridge this association are measured and analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer | Diagnosed breast cancer patients who are getting chemotherapy for the first time. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The data progression-free survival will be done by reviewing patients' medical record. | 3 years (and more) after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian disruption | Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment. | Baseline, after 1 month, after 6 month, after 12 month |
| Objective sleep cycle measures |
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Inclusion Criteria:
Exclusion Criteria:
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University (Tertiary) hospital, oncology clinic
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| Name | Affiliation | Role |
|---|---|---|
| Bong-Jin Hahm, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 140-013 | South Korea |
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| Label | URL |
|---|---|
| study site webpage | View source |
| Institutional Review Board | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Whole blood, serum Saliva Urine
The assessment will be performed by using actigraph and sleep diary.
| Baseline, after 1 month, after 6 month, after 12 month |
| Physiological measures | The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography. | Baseline, after 1 month, after 6 month, after 12 month |
| Sleep quality measures | The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index. | Baseline, after 1 month, after 6 month, after 12 month |
| Quality of Life measure | The measurement will be performed using M.D. Anderson Symptom Inventory. | Baseline, after 1 month, after 6 month, after 12 month |
| Cancer related Fatigue | Fatigue severity scale will be used during the assessment. | Baseline, after 1 month, after 6 month, after 12 month |
| Distress related measure | Hospital Anxiety and Depression Scale will be used during the assessment. | Baseline, after 1 month, after 6 month, after 12 month |
| Posttraumatic Stress-related symptom measure | Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients. | Baseline, after 1 month, after 6 month, after 12 month |
| Menopausal symptom measure | Menopause Rating Scale will be used during the assessment. | Baseline, after 1 month, after 6 month, after 12 month |
| Personality measure | Temperament and Character Inventory will be used to examine the personality factor in each participant. | Baseline |
| Genetic polymorphism | Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined. | Baseline |
| Epigenetic Change | The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level. | Baseline |
| Cortisol level | Salivary cortisol level will be measured multiple times at baseline. | Baseline |
| Melatonin | Salivary or Urine melatonin level will be measured. | Baseline |
| Inflammatory markers | The various inflammation markers will be measured from blood sample. | Baseline |
| Overall survival | The data progression-free survival will be done by reviewing patients' medical record. | 3 years (and more) after recruitment |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |