Clinical trial NCT05055375: The Psychology of Chinese Breast Cancer Patients
Official title: The Psychology of Chinese Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese female patients with early breast cancer

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Psychological Distress Thermometer(DT)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Depression Scale (HADS)
timeFrame: through study completion, an average of 2 year
measure: Social Support Rating Scale (SSRS)
timeFrame: through study completion, an average of 2 year
measure: The Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
timeFrame: through study completion, an average of 2 year
measure: Zarit Caregiver Burden Interview (ZBI)
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
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