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Intervention Study of Depression in Breast Cancer Patients

Primary Purpose

Breast Cancer, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CBT
Clinical Management
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Depression, Anxiety, Cognitive-Behavioral Therapy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 20-65 years;
  • Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
  • A week after breast cancer surgery;
  • With complaints and symptoms of depression or anxiety
  • HAMD-17 ≥ 8 points or / and HAMA ≥ 8 points;
  • Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
  • Informed consent

Exclusion Criteria:

  • Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;
  • Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
  • Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
  • Hearing, visual or understanding impairment;
  • Severe depression, suicidal tendencies;
  • Can not or will not comply with clinical treatment programs based on the physicians' judgment

Exit criteria:

  • Persons with poor compliance during the trial period;
  • Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
  • Persons who are believed have other circumstances and should be suspended by Physicians

Sites / Locations

  • Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

No Intervention

Arm Label

stage 1 Clinical Management

stage1 CBT

stage1 Control group

Arm Description

The group will receive clinical management treatment only each session.

The experimental group will receive CBT

Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HAMD-17)
The scale(HAMD-17) is used to assessed the depression symptoms of patients. The scale range is 0-53.Higher value represents a worse outcome. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week
Hamilton Anxiety Scale (HAMA-14)
The scale(HAMA-14) is used to assessed the anxiety symptoms of patients. The scale range is 0-56.Higher value represents a worse outcome. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week.

Secondary Outcome Measures

Visual Analogue Scale (VAS)
The scale is used to assess the pain intensity of patients. The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Athens Insomnia Scale(AIS)
The scale is used to assess the sleep quality of patients. The scale range of AIS is 0-21. Higher score indicates worse sleep quality. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Functional Assessment of Cancer Treatment (FACT-B)
The scale is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-144. Higher score indicates better life quality. The scale was assessed at baseline,4 week,12 week,24 week.

Full Information

First Posted
December 6, 2010
Last Updated
April 9, 2015
Sponsor
Wenzhou Medical University
Collaborators
Anhui Medical University, Central South University, Harbin Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Wuhan University
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1. Study Identification

Unique Protocol Identification Number
NCT01256008
Brief Title
Intervention Study of Depression in Breast Cancer Patients
Official Title
Early Identification and Early Warning of Psychological Problems in Breast Cancer Patients, and Intervention Study Using Cognitive Behavioral Therapy on Depression in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
Collaborators
Anhui Medical University, Central South University, Harbin Medical University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Wuhan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.
Detailed Description
Comprehensive intervention on depression and anxiety in breast cancer patients is a 24-week, multicenter, randomized, blinded controlled clinical study, which uses cognitive-behavioral therapy. This study tries to evaluate the efficacy of sequential therapy on breast cancer patients' depression and its improvement on breast cancer patients' life quality, pain and sleeping.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Depression, Anxiety
Keywords
Breast Cancer, Depression, Anxiety, Cognitive-Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
stage 1 Clinical Management
Arm Type
Placebo Comparator
Arm Description
The group will receive clinical management treatment only each session.
Arm Title
stage1 CBT
Arm Type
Experimental
Arm Description
The experimental group will receive CBT
Arm Title
stage1 Control group
Arm Type
No Intervention
Arm Description
Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
cognitive-behavioral intervention, psychological intervention
Intervention Description
The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Management
Other Intervention Name(s)
Placebo of Cognitive-Behavioral therapy
Intervention Description
Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention. Following are major elements: Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAMD-17)
Description
The scale(HAMD-17) is used to assessed the depression symptoms of patients. The scale range is 0-53.Higher value represents a worse outcome. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week
Time Frame
baseline,2 w,4 w,8 w,12 w,16 w,24 w
Title
Hamilton Anxiety Scale (HAMA-14)
Description
The scale(HAMA-14) is used to assessed the anxiety symptoms of patients. The scale range is 0-56.Higher value represents a worse outcome. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week.
Time Frame
baseline,2 w,4 w,8 w,12 w,16 w,24 w
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
The scale is used to assess the pain intensity of patients. The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Time Frame
baseline,4 w,8 w,12 w,24 w
Title
Athens Insomnia Scale(AIS)
Description
The scale is used to assess the sleep quality of patients. The scale range of AIS is 0-21. Higher score indicates worse sleep quality. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Time Frame
baseline, 4w,8w,12w,24w
Title
Functional Assessment of Cancer Treatment (FACT-B)
Description
The scale is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-144. Higher score indicates better life quality. The scale was assessed at baseline,4 week,12 week,24 week.
Time Frame
baseline, 4w,12w,24w

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 20-65 years; Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer; A week after breast cancer surgery; With complaints and symptoms of depression or anxiety HAMD-17 ≥ 8 points or / and HAMA ≥ 8 points; Have some reading comprehension skills (could complete the self-rating scale independently or with others' help); Informed consent Exclusion Criteria: Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history; Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases; Hearing, visual or understanding impairment; Severe depression, suicidal tendencies; Can not or will not comply with clinical treatment programs based on the physicians' judgment Exit criteria: Persons with poor compliance during the trial period; Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention; Persons who are believed have other circumstances and should be suspended by Physicians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin C He, MD
Organizational Affiliation
Wenzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

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Intervention Study of Depression in Breast Cancer Patients

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