The Psychology of Chinese Breast Cancer Patients
- Conditions
- Breast Cancer
- Registration Number
- NCT05055375
- Lead Sponsor
- Ma Fei，MD
- Brief Summary
Earlier diagnosis of breast cancer in women and the use of systemic adjuvant therapy have increased the likelihood of long term, disease free survival.women who remain free of breast cancer seem to have levels of functioning and quality of life that are comparable to those of the general female population.It will be assessed the psychology status of women with breast cancer using a clinical interview,
- Detailed Description
It conducts a questionnaire survey of 300 patients. The questionnaires used are: Psychological Pain Thermometer DT, Hospital Anxiety and Depression Scale HADS, Quality of Life Scale for Breast Cancer Patients FACT-B, Social Support Rating Scale SSRS. Caregivers should fill in the following scales: Psychological Pain Thermometer DT, Hospital Anxiety and Depression Scale HADS, Caregiver Burden Assessment Scale ZBI. Inclusion criteria: 1,female patients with early breast cancer after surgery; 2,no previous mental and psychological abnormalities; 3,Postoperative and prepare to accept adjuvant chemotherapy ; 4,Patient's know her/his illness .
To explore:
1. Psychological status and dynamic changes of patients and caregivers during adjuvant chemotherapy after breast cancer surgery in China.
2. The influence of psychological status of Chinese breast cancer patients on adverse reactions during adjuvant chemotherapy.
3. Gene susceptibility to psychological abnormalities during adjuvant chemotherapy for breast cancer in China.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 300
Age：18~75 years; Early stage breast cancer confirmed by histology examination; Patients had undergone surgery for breast cancer; No distant metastasis; Planned to receive recommended postoperative adjuvant chemotherapy; Voluntarily provided written informed consent.
Patients already receiving neoadjuvant chemotherapy before surgery; Patients had metastatic disease at diagnosis; Patients had difficulty understanding the questionnaire or communicating in Chinese; Patients had significant psychiatric or other comorbid disease prohibiting participation; Any other researcher believes that it is not appropriate to participate in this test.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Psychological Distress Thermometer(DT) through study completion, an average of 2 year DT uses to identify sources of distress. It uses a 0 (no distress) to 10 (extreme distress).
- Secondary Outcome Measures
Name Time Method Depression Scale (HADS) through study completion, an average of 2 year HADS was divided into an anxiety subscale and a depression subscale. Each item is scored from 0 (not at all) to 3 (very much) such that total scores on each sub-scale may range from 0-21.
Zarit Caregiver Burden Interview (ZBI) through study completion, an average of 2 year ZBI Is developed as 29-item self-report scale aimed to assess the subjective burden experienced by an caregiver.
Social Support Rating Scale (SSRS) through study completion, an average of 2 year Social support was measured by SSRS. The total score ranges from 12 to 66 points, and higher score indicates higher social support for patients.
The Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) through study completion, an average of 2 year The FACT-B is a 37-item instrument evaluating QoL issues. The domain scores for physical, social/family and functional well-being range from 0 to 28, the emotional domain scores from 0 to 24 points, the breast cancer- specific subscale domain scores from 0 to 40.
Trial Locations
- Locations (1)
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China