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| Name | Class |
|---|---|
| Anhui Medical University | OTHER |
| Central South University | OTHER |
| Harbin Medical University | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University |
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The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stage 1 Clinical Management | Placebo Comparator | The group will receive clinical management treatment only each session. |
|
| stage1 CBT | Experimental | The experimental group will receive CBT |
|
| stage1 Control group | No Intervention | Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Rating Scale (HAMD-17) |
| baseline,2 w,4 w,8 w,12 w,16 w,24 w |
| Hamilton Anxiety Scale (HAMA-14) |
| baseline,2 w,4 w,8 w,12 w,16 w,24 w |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) |
| baseline,4 w,8 w,12 w,24 w |
| Athens Insomnia Scale(AIS) |
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Inclusion Criteria:
Exclusion Criteria:
Exit criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin C He, MD | Wenzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1 Clinical Management | The group will receive clinical management treatment only each session. Clinical Management: 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. |
| FG001 | Stage 1 CBT | The experimental group will receive CBT each session. CBT: 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. |
| FG002 | Stage 1 Control Group | Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1 Clinical Management | The group will receive clinical management treatment only each session. Clinical Management: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Depression Rating Scale (HAMD-17) |
| Posted | Mean | Standard Deviation | units on a scale | baseline,2 w,4 w,8 w,12 w,16 w,24 w |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 1 Clinical Management | The group will receive clinical management treatment only each session. Clinical Management: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Wenzhou Medical University | +86 0577 55579363 | hjc@wmu.edu.cn |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000083626 | Psychosocial Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| OTHER |
| Wuhan University | OTHER |
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|
|
| Clinical Management | Behavioral | 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. |
|
|
|
| baseline, 4w,8w,12w,24w |
| Functional Assessment of Cancer Treatment (FACT-B) |
| baseline, 4w,12w,24w |
| BG001 | stage1 CBT | The experimental group each session. CBT: 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. |
| BG002 | stage1 Control Group | Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Stage 1 CBT | The experimental group will receive CBT each session. CBT and clinical management: 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. |
| OG002 | Stage 1 Control Group | Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions. |
|
|
| Secondary | Visual Analogue Scale (VAS) |
| Posted | Mean | Standard Deviation | units on a scale | baseline,4 w,8 w,12 w,24 w |
|
|
|
| Primary | Hamilton Anxiety Scale (HAMA-14) |
| Posted | Mean | Standard Deviation | units on a scale | baseline,2 w,4 w,8 w,12 w,16 w,24 w |
|
|
|
| Secondary | Athens Insomnia Scale(AIS) |
| Posted | Mean | Standard Deviation | units on a scale | baseline, 4w,8w,12w,24w |
|
|
|
| Secondary | Functional Assessment of Cancer Treatment (FACT-B) |
| Posted | Mean | Standard Deviation | units on a scale | baseline, 4w,12w,24w |
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | stage1 CBT | The experimental group will receive CBT each session. CBT and clinical management: 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. | 0 | 98 | 0 | 98 |
| EG002 | stage1 Control Group | Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions. | 0 | 196 | 0 | 196 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
|
| 8W |
|
| 12W |
|
| 24W |
|
|
| 4W |
|
| 8W |
|
| 12W |
|
| 16W |
|
| 24W |
|
|
| 8W |
|
| 12W |
|
| 24W |
|
|
| 12W |
|
| 24W |
|