The Psychology of Chinese Breast Cancer Patients

September 21, 2021 updated by: Ma Fei，MD
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,

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Cancer hospital, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Chinese female patients with early breast cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Distress Thermometer(DT)
Time Frame: 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).
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Scale (HADS)
Time Frame: 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.
through study completion, an average of 2 year
Social Support Rating Scale (SSRS)
Time Frame: 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.
through study completion, an average of 2 year
The Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
Time Frame: 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.
through study completion, an average of 2 year
Zarit Caregiver Burden Interview (ZBI)
Time Frame: 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.
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ma Fei，MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

September 21, 2021

First Posted (Actual)

September 24, 2021

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC1867

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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