The Effects of Circadian Gene on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is the evaluation of effect of circadian gene on sleep and other symptoms in breast cancer patients under chemotherapy.

Detailed Description
-----------------
In this study, the investigators are going to examine the effect of genetic polymorphism on sleep, anxiety, depression and other cancer-related symptoms in patients with breast cancer who have started chemotherapy after surgery. No intervention was intended and blood sample was taken with other routine laboratory tests.

Official Title
-----------------
The Effects of Per3, Clock Polymorphism on Sleep and Associated Symptoms in Breast Cancer Patients Under Chemotherapy.

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-70 Patient with breast cancer without metastasis Patient received cancer surgery and medically stable Patient will undergo chemotherapy for the first time in life Patient have signed on the informed consent, and well understood the objective and procedure of this study Exclusion Criteria: Patient received chemotherapy or radiotherapy Patient had another cancer before Patient have metastasis 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| breast cancer<br>breast cancer patients receiving chemotherapy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Sleep Impairment at 1 Month After Chemotherapy | Sleep impairment will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy. | baseline, 1 month, 3 months, 1 month after chemotherpy completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Quality of Life at 1 Month After Chemotherapy | Quality of life will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month after completion of the chemotherapy. | baseline, 1 month after chemotherpy completion | 
| Changes from Baseline Cancer-related Symptoms at 1 Month After Chemotherapy | Cancer-related symptoms will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy. | baseline, 1 month, 3 months, 1 month after chemotherpy completion | 
| Changes from Baseline Fatigue at 1 Month After Chemotherapy | Fatigue will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy. | baseline, 1 month, 3 months, 1 month after chemotherpy completion | 
| Changes from Baseline Depression at 1 Month After Chemotherapy | Depression will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy. | baseline, 1 month, 3 months, 1 month after chemotherpy completion | 
| Changes from Baseline Anxiety 1 Month After Chemotherapy | Anxiety will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy. | baseline, 1 month, 3 months, 1 month after chemotherpy completion | 
| Changes from Baseline PTSD Symptoms 1 Month After Chemotherapy | PTSD symptoms will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy. | baseline, 1 month, 3 months, 1 month after chemotherpy completion | 
| Changes from Baseline Menopausal Symptoms 1 Month After Chemotherapy | Menopausal symptoms will be evaluated by questionnaires before chemotherapy. The evaluation will be followed 1 month, 3 months after starting chemotherapy. The final evaluation will be done 1 month after completion of the chemotherapy. | baseline, 1 month, 3 months, 1 month after chemotherpy completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast neoplasms, sleep, anxiety, depression, life quality