Breast Neoplasms
Conditions
Keywords
Breast neoplasms, Circadian rhythm, sleep, survival, distress, anxiety, depression, quality of life, actigraph, fatigue
Brief summary
The purpose of this study is to explore the possible association between the circadian disruption and cancer progression.
Detailed description
The biological markers that are assumed to bridge this association are measured and analyzed.
Interventions
None listed
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-70 * Breast cancer patients who are getting chemotherapy for the first time in life * Patients are either having stage 4 cancer or starting neoadjuvant chemotherapy. * Patient have signed on the informed consent, and well understood the objective and procedure of this study
Exclusion criteria
* Patients already have received chemotherapy * Patient had another cancer (except thyroid cancer) within 5 years * Patient with severe medical condition * Patient had taken psychiatric medication more than 1 month in life * Patient worked the night shift for more than 1 month in 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 3 years (and more) after recruitment | The data progression-free survival will be done by reviewing patients' medical record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective sleep cycle measures | Baseline, after 1 month, after 6 month, after 12 month | The assessment will be performed by using actigraph and sleep diary. |
| Physiological measures | Baseline, after 1 month, after 6 month, after 12 month | The measures include blood pressure, body temperature, skin conductance, breathing pattern, and Electroencephalography. |
| Sleep quality measures | Baseline, after 1 month, after 6 month, after 12 month | The measurements will be performed using Epworth sleepiness scale, Pittsburgh Sleep Quality Index, and Insomnia Severity Index. |
| Quality of Life measure | Baseline, after 1 month, after 6 month, after 12 month | The measurement will be performed using M.D. Anderson Symptom Inventory. |
| Cancer related Fatigue | Baseline, after 1 month, after 6 month, after 12 month | Fatigue severity scale will be used during the assessment. |
| Distress related measure | Baseline, after 1 month, after 6 month, after 12 month | Hospital Anxiety and Depression Scale will be used during the assessment. |
| Posttraumatic Stress-related symptom measure | Baseline, after 1 month, after 6 month, after 12 month | Impact of Event Scale-revised will be used to categorize and quantify Posttraumatic stress-related symptom in cancer patients. |
| Circadian disruption | Baseline, after 1 month, after 6 month, after 12 month | Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire will be used during assessment. |
| Personality measure | Baseline | Temperament and Character Inventory will be used to examine the personality factor in each participant. |
| Genetic polymorphism | Baseline | Variable Number Tandem Repeat and Single Nucleotide Polymorphism of circadian-rhythm related genes will be examined. |
| Epigenetic Change | Baseline | The methylation specific Polymerase Chain Reaction technique will be used to explore methylation patterns in circadian clock gene or in a global gene level. |
| Cortisol level | Baseline | Salivary cortisol level will be measured multiple times at baseline. |
| Melatonin | Baseline | Salivary or Urine melatonin level will be measured. |
| Inflammatory markers | Baseline | The various inflammation markers will be measured from blood sample. |
| Overall survival | 3 years (and more) after recruitment | The data progression-free survival will be done by reviewing patients' medical record. |
| Menopausal symptom measure | Baseline, after 1 month, after 6 month, after 12 month | Menopause Rating Scale will be used during the assessment. |
Countries
South Korea
Outcome results
None listed