Breast Cancer, Depression, Anxiety
Conditions
Keywords
Breast Cancer, Depression, Anxiety, Cognitive-Behavioral Therapy
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.
Interventions
BEHAVIORALCBT
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.
BEHAVIORALClinical 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.
Sponsors
Anhui Medical University
Central South University
Harbin Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Wuhan University
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAMD-17) | baseline,2 w,4 w,8 w,12 w,16 w,24 w | 1. The scale(HAMD-17) is used to assessed the depression symptoms of patients. 2. The scale range is 0-53.Higher value represents a worse outcome. 3. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week |
| Hamilton Anxiety Scale (HAMA-14) | baseline,2 w,4 w,8 w,12 w,16 w,24 w | 1. The scale(HAMA-14) is used to assessed the anxiety symptoms of patients. 2. The scale range is 0-56.Higher value represents a worse outcome. 3. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) | baseline,4 w,8 w,12 w,24 w | 1. The scale is used to assess the pain intensity of patients. 2. The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain. 3. The scale was assessed at baseline,4 week,8 week,12 week,24 week |
| Athens Insomnia Scale(AIS) | baseline, 4w,8w,12w,24w | 1. The scale is used to assess the sleep quality of patients. 2. The scale range of AIS is 0-21. Higher score indicates worse sleep quality. 3. The scale was assessed at baseline,4 week,8 week,12 week,24 week |
| Functional Assessment of Cancer Treatment (FACT-B) | baseline, 4w,12w,24w | 1. The scale is used to assess the life quality of patients. 2. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. 3. The scale range is 0-144. Higher score indicates better life quality. 4. The scale was assessed at baseline,4 week,12 week,24 week. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| 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. | 98 |
| stage1 Control Group Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions. | 196 |
| Total | 392 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 | 11 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 10 |
Baseline characteristics
| Characteristic | Stage 1 Clinical Management | stage1 CBT | stage1 Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 8.7 | 46.8 years STANDARD_DEVIATION 8.9 | 47.1 years STANDARD_DEVIATION 8.3 | 47.1 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 98 Participants | 98 Participants | 196 Participants | 392 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 98 | 0 / 98 | 0 / 196 |
| serious Total, serious adverse events | 0 / 98 | 0 / 98 | 0 / 196 |
Outcome results
Primary
Hamilton Anxiety Scale (HAMA-14)
1. The scale(HAMA-14) is used to assessed the anxiety symptoms of patients. 2. The scale range is 0-56.Higher value represents a worse outcome. 3. 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Clinical Management | Hamilton Anxiety Scale (HAMA-14) | 2W | 10.89 units on a scale | Standard Deviation 3.401 |
| Stage 1 Clinical Management | Hamilton Anxiety Scale (HAMA-14) | 12W | 8.57 units on a scale | Standard Deviation 3.364 |
| Stage 1 Clinical Management | Hamilton Anxiety Scale (HAMA-14) | 8W | 9.15 units on a scale | Standard Deviation 3.709 |
| Stage 1 Clinical Management | Hamilton Anxiety Scale (HAMA-14) | baseline | 12.11 units on a scale | Standard Deviation 3.188 |
| Stage 1 Clinical Management | Hamilton Anxiety Scale (HAMA-14) | 24W | 7.60 units on a scale | Standard Deviation 3.305 |
| Stage 1 Clinical Management | Hamilton Anxiety Scale (HAMA-14) | 16W | 7.90 units on a scale | Standard Deviation 3.263 |
| Stage 1 Clinical Management | Hamilton Anxiety Scale (HAMA-14) | 4W | 10.34 units on a scale | Standard Deviation 3.505 |
| Stage 1 CBT | Hamilton Anxiety Scale (HAMA-14) | 8W | 8.26 units on a scale | Standard Deviation 4.12 |
| Stage 1 CBT | Hamilton Anxiety Scale (HAMA-14) | baseline | 13.38 units on a scale | Standard Deviation 4.883 |
| Stage 1 CBT | Hamilton Anxiety Scale (HAMA-14) | 2W | 11.34 units on a scale | Standard Deviation 4.433 |
| Stage 1 CBT | Hamilton Anxiety Scale (HAMA-14) | 4W | 9.82 units on a scale | Standard Deviation 3.952 |
| Stage 1 CBT | Hamilton Anxiety Scale (HAMA-14) | 12W | 6.30 units on a scale | Standard Deviation 3.518 |
| Stage 1 CBT | Hamilton Anxiety Scale (HAMA-14) | 16W | 5.42 units on a scale | Standard Deviation 3.638 |
| Stage 1 CBT | Hamilton Anxiety Scale (HAMA-14) | 24W | 4.99 units on a scale | Standard Deviation 3.263 |
| Stage 1 Control Group | Hamilton Anxiety Scale (HAMA-14) | 12W | 8.81 units on a scale | Standard Deviation 4.231 |
| Stage 1 Control Group | Hamilton Anxiety Scale (HAMA-14) | 2W | 10.63 units on a scale | Standard Deviation 3.105 |
| Stage 1 Control Group | Hamilton Anxiety Scale (HAMA-14) | 24W | 7.91 units on a scale | Standard Deviation 4.277 |
| Stage 1 Control Group | Hamilton Anxiety Scale (HAMA-14) | 16W | 8.31 units on a scale | Standard Deviation 4.348 |
| Stage 1 Control Group | Hamilton Anxiety Scale (HAMA-14) | 8W | 9.36 units on a scale | Standard Deviation 3.802 |
| Stage 1 Control Group | Hamilton Anxiety Scale (HAMA-14) | 4W | 10.40 units on a scale | Standard Deviation 3.663 |
| Stage 1 Control Group | Hamilton Anxiety Scale (HAMA-14) | baseline | 11.37 units on a scale | Standard Deviation 2.736 |
Primary
Hamilton Depression Rating Scale (HAMD-17)
1. The scale(HAMD-17) is used to assessed the depression symptoms of patients. 2. The scale range is 0-53.Higher value represents a worse outcome. 3. 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Clinical Management | Hamilton Depression Rating Scale (HAMD-17) | 24W | 7.01 units on a scale | Standard Deviation 3.317 |
| Stage 1 Clinical Management | Hamilton Depression Rating Scale (HAMD-17) | 12W | 8.01 units on a scale | Standard Deviation 3.2 |
| Stage 1 Clinical Management | Hamilton Depression Rating Scale (HAMD-17) | 8W | 8.71 units on a scale | Standard Deviation 3.601 |
| Stage 1 Clinical Management | Hamilton Depression Rating Scale (HAMD-17) | 2W | 10.23 units on a scale | Standard Deviation 3.207 |
| Stage 1 Clinical Management | Hamilton Depression Rating Scale (HAMD-17) | baseline | 11.52 units on a scale | Standard Deviation 3.789 |
| Stage 1 Clinical Management | Hamilton Depression Rating Scale (HAMD-17) | 16W | 7.42 units on a scale | Standard Deviation 3.019 |
| Stage 1 Clinical Management | Hamilton Depression Rating Scale (HAMD-17) | 4W | 9.80 units on a scale | Standard Deviation 3.056 |
| Stage 1 CBT | Hamilton Depression Rating Scale (HAMD-17) | 8W | 7.80 units on a scale | Standard Deviation 4.44 |
| Stage 1 CBT | Hamilton Depression Rating Scale (HAMD-17) | baseline | 13.31 units on a scale | Standard Deviation 5.09 |
| Stage 1 CBT | Hamilton Depression Rating Scale (HAMD-17) | 2W | 11.72 units on a scale | Standard Deviation 4.976 |
| Stage 1 CBT | Hamilton Depression Rating Scale (HAMD-17) | 4W | 9.72 units on a scale | Standard Deviation 4.835 |
| Stage 1 CBT | Hamilton Depression Rating Scale (HAMD-17) | 12W | 5.71 units on a scale | Standard Deviation 3.979 |
| Stage 1 CBT | Hamilton Depression Rating Scale (HAMD-17) | 16W | 5.13 units on a scale | Standard Deviation 4.108 |
| Stage 1 CBT | Hamilton Depression Rating Scale (HAMD-17) | 24W | 4.45 units on a scale | Standard Deviation 3.875 |
| Stage 1 Control Group | Hamilton Depression Rating Scale (HAMD-17) | 12W | 8.81 units on a scale | Standard Deviation 4.198 |
| Stage 1 Control Group | Hamilton Depression Rating Scale (HAMD-17) | 2W | 10.28 units on a scale | Standard Deviation 3.462 |
| Stage 1 Control Group | Hamilton Depression Rating Scale (HAMD-17) | 24W | 7.86 units on a scale | Standard Deviation 4.41 |
| Stage 1 Control Group | Hamilton Depression Rating Scale (HAMD-17) | 16W | 8.26 units on a scale | Standard Deviation 4.338 |
| Stage 1 Control Group | Hamilton Depression Rating Scale (HAMD-17) | 8W | 9.42 units on a scale | Standard Deviation 4.175 |
| Stage 1 Control Group | Hamilton Depression Rating Scale (HAMD-17) | 4W | 10.24 units on a scale | Standard Deviation 3.688 |
| Stage 1 Control Group | Hamilton Depression Rating Scale (HAMD-17) | baseline | 11.01 units on a scale | Standard Deviation 3.844 |
Secondary
Athens Insomnia Scale(AIS)
1. The scale is used to assess the sleep quality of patients. 2. The scale range of AIS is 0-21. Higher score indicates worse sleep quality. 3. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Time frame: baseline, 4w,8w,12w,24w
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Clinical Management | Athens Insomnia Scale(AIS) | 12W | 5.63 units on a scale | Standard Deviation 4.335 |
| Stage 1 Clinical Management | Athens Insomnia Scale(AIS) | 8W | 5.87 units on a scale | Standard Deviation 4.414 |
| Stage 1 Clinical Management | Athens Insomnia Scale(AIS) | baseline | 6.95 units on a scale | Standard Deviation 4.337 |
| Stage 1 Clinical Management | Athens Insomnia Scale(AIS) | 4W | 6.06 units on a scale | Standard Deviation 3.865 |
| Stage 1 Clinical Management | Athens Insomnia Scale(AIS) | 24W | 5.34 units on a scale | Standard Deviation 4.505 |
| Stage 1 CBT | Athens Insomnia Scale(AIS) | 8W | 4.22 units on a scale | Standard Deviation 3.236 |
| Stage 1 CBT | Athens Insomnia Scale(AIS) | baseline | 8.49 units on a scale | Standard Deviation 4.341 |
| Stage 1 CBT | Athens Insomnia Scale(AIS) | 4W | 5.37 units on a scale | Standard Deviation 3.268 |
| Stage 1 CBT | Athens Insomnia Scale(AIS) | 24W | 2.40 units on a scale | Standard Deviation 2.054 |
| Stage 1 CBT | Athens Insomnia Scale(AIS) | 12W | 2.90 units on a scale | Standard Deviation 2.242 |
| Stage 1 Control Group | Athens Insomnia Scale(AIS) | 4W | 6.19 units on a scale | Standard Deviation 4.235 |
| Stage 1 Control Group | Athens Insomnia Scale(AIS) | 24W | 5.63 units on a scale | Standard Deviation 4.946 |
| Stage 1 Control Group | Athens Insomnia Scale(AIS) | 12W | 5.85 units on a scale | Standard Deviation 4.749 |
| Stage 1 Control Group | Athens Insomnia Scale(AIS) | 8W | 5.99 units on a scale | Standard Deviation 4.507 |
| Stage 1 Control Group | Athens Insomnia Scale(AIS) | baseline | 7.14 units on a scale | Standard Deviation 4.475 |
Secondary
Functional Assessment of Cancer Treatment (FACT-B)
1. The scale is used to assess the life quality of patients. 2. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. 3. The scale range is 0-144. Higher score indicates better life quality. 4. The scale was assessed at baseline,4 week,12 week,24 week.
Time frame: baseline, 4w,12w,24w
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Clinical Management | Functional Assessment of Cancer Treatment (FACT-B) | 24W | 95.06 units on a scale | Standard Deviation 17.54 |
| Stage 1 Clinical Management | Functional Assessment of Cancer Treatment (FACT-B) | 12W | 89.69 units on a scale | Standard Deviation 16.22 |
| Stage 1 Clinical Management | Functional Assessment of Cancer Treatment (FACT-B) | 4W | 80.41 units on a scale | Standard Deviation 19.14 |
| Stage 1 Clinical Management | Functional Assessment of Cancer Treatment (FACT-B) | baseline | 78.09 units on a scale | Standard Deviation 18.86 |
| Stage 1 CBT | Functional Assessment of Cancer Treatment (FACT-B) | 12W | 102.94 units on a scale | Standard Deviation 20.24 |
| Stage 1 CBT | Functional Assessment of Cancer Treatment (FACT-B) | 4W | 86.67 units on a scale | Standard Deviation 18.74 |
| Stage 1 CBT | Functional Assessment of Cancer Treatment (FACT-B) | baseline | 76.78 units on a scale | Standard Deviation 19.91 |
| Stage 1 CBT | Functional Assessment of Cancer Treatment (FACT-B) | 24W | 109.21 units on a scale | Standard Deviation 19.62 |
| Stage 1 Control Group | Functional Assessment of Cancer Treatment (FACT-B) | 4W | 80.07 units on a scale | Standard Deviation 22.04 |
| Stage 1 Control Group | Functional Assessment of Cancer Treatment (FACT-B) | baseline | 79.49 units on a scale | Standard Deviation 21.06 |
| Stage 1 Control Group | Functional Assessment of Cancer Treatment (FACT-B) | 24W | 89.70 units on a scale | Standard Deviation 25.76 |
| Stage 1 Control Group | Functional Assessment of Cancer Treatment (FACT-B) | 12W | 85.14 units on a scale | Standard Deviation 24.61 |
Secondary
Visual Analogue Scale (VAS)
1. The scale is used to assess the pain intensity of patients. 2. The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain. 3. 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Clinical Management | Visual Analogue Scale (VAS) | 12W | 1.92 units on a scale | Standard Deviation 1.857 |
| Stage 1 Clinical Management | Visual Analogue Scale (VAS) | 8W | 2.11 units on a scale | Standard Deviation 1.845 |
| Stage 1 Clinical Management | Visual Analogue Scale (VAS) | baseline | 3.23 units on a scale | Standard Deviation 2.24 |
| Stage 1 Clinical Management | Visual Analogue Scale (VAS) | 4W | 2.39 units on a scale | Standard Deviation 1.907 |
| Stage 1 Clinical Management | Visual Analogue Scale (VAS) | 24W | 1.71 units on a scale | Standard Deviation 1.982 |
| Stage 1 CBT | Visual Analogue Scale (VAS) | 8W | 1.89 units on a scale | Standard Deviation 1.899 |
| Stage 1 CBT | Visual Analogue Scale (VAS) | baseline | 3.60 units on a scale | Standard Deviation 2.171 |
| Stage 1 CBT | Visual Analogue Scale (VAS) | 4W | 2.48 units on a scale | Standard Deviation 2.173 |
| Stage 1 CBT | Visual Analogue Scale (VAS) | 12W | 1.71 units on a scale | Standard Deviation 1.703 |
| Stage 1 CBT | Visual Analogue Scale (VAS) | 24W | 1.45 units on a scale | Standard Deviation 1.772 |
| Stage 1 Control Group | Visual Analogue Scale (VAS) | 24W | 2.04 units on a scale | Standard Deviation 2.094 |
| Stage 1 Control Group | Visual Analogue Scale (VAS) | 12W | 2.23 units on a scale | Standard Deviation 2.025 |
| Stage 1 Control Group | Visual Analogue Scale (VAS) | baseline | 3.31 units on a scale | Standard Deviation 1.956 |
| Stage 1 Control Group | Visual Analogue Scale (VAS) | 8W | 2.41 units on a scale | Standard Deviation 1.882 |
| Stage 1 Control Group | Visual Analogue Scale (VAS) | 4W | 2.71 units on a scale | Standard Deviation 1.806 |