Behaviors and Mental Disorders

All Conditions

Depression

Anxiety Disorders

Depressive Disorder

Depressive Disorder, Major

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Mood Disorders

Psychotropic Drugs

All Drugs and Chemicals

Antidepressive Agents

DNA-guided choice of antidepressant therapy

Buccal swab for DNA genotyping to identify best antidepressant therapy

DNA-guided choice of therapy

Clinical management to identify best antidepressant therapy

Clinical management

James K Hicks, PharmD, PhD

This is a prospective, randomized clinical trial to investigate the clinical impact of a preemptive pharmacogenomics strategy to guide antidepressant therapy in cancer patients. Those enrolled onto the clinical trial will be randomized to either DNA-guided choice of therapy or clinical management alone. Scores on self-reported measures of depressive and anxiety symptoms along with quality of life will be compared between cohorts.

Patients will be blinded to the genomic results for 12 weeks, with the 12 week time period starting at the time of antidepressant drug prescribing.

Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients

The Hospital Anxiety and Depression scale can range from 0 to 42 (14 questions each on a 0-3 point scale).

Quality of Life as measured by Functional Assessment of Cancer Therapy-General (FACT-G) Scale. FACT-G is a quality of life questionnaire with values ranging from 0 (not at all) to 4 (very much). The categories of measure are physical, social/family, emotional and functional well-being.

H. Lee Moffitt Cancer Center and Research Institute

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Disease Progression

Breast Diseases

Skin Diseases

Patients newly diagnosed with metastatic breast cancer, either De Novo or having progressed from a non-metastatic stage.

The purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria.

A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study

AstraZeneca

The group will receive clinical management treatment only each session.

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

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.

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.

Clinical Management

Jin C He, MD

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.

Intervention Study of Depression in Breast Cancer Patients

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

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

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.

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

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

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.

Anhui Medical University

Central South University

Harbin Medical University

Second Affiliated Hospital, School of Medicine, Zhejiang University

Wuhan University

Wenzhou Medical University

Study Chair

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.

Stage 1 Clinical Management

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.

stage1 CBT

stage1 Control Group

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.

Total

Age, Continuous

Sex: Female, Male

Director of Clinical Trials

baseline

Stage 1 CBT

Stage 1 Control Group

Hamilton Depression Rating Scale (HAMD-17)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients	NCT03674138	Depression Anxiety Generalized Anx... Depressive Diso... Major Depressiv... Cancer	DNA-guided choi... Clinical manage...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study	NCT01715155	Metastatic Brea...		18 Years -	AstraZeneca
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients	NCT03674138	Depression Anxiety Generalized Anx... Depressive Diso... Major Depressiv... Cancer	DNA-guided choi... Clinical manage...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Pharmacogenomic-Guided Antidepressant Drug Prescribing in Cancer Patients	NCT03674138	Depression Anxiety Generalized Anx... Depressive Diso... Major Depressiv... Cancer	DNA-guided choi... Clinical manage...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study	NCT01715155	Metastatic Brea...		18 Years -	AstraZeneca
Intervention Study of Depression in Breast Cancer Patients	NCT01256008	Breast Cancer Depression Anxiety	CBT Clinical Manage...	20 Years - 65 Years	Wenzhou Medical University

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