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IRCT20200422047170N1 IRCT 2020-06-20 Iranian academic center for education culture and research Effect of psychotherapy on the side effects of breast cancer Comparison of the effectiveness of group consulting based on meta-cognitive therapy and trans-personal therapy on coping strategies ، fear of recurrence and resilience, quality of life, anxiety, depression, hope in breast cancer survivors 2020-06-21 anticipated 90 Complete https://irct.ir/trial/47460 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Breast cancer survivors are invited to participate in several medical centers after complete treatment. Then, at the first visit to the follow-up clinic, those who completed the informed consent are registered and randomly assigned to one of the three study groups, with using a table of random numbers. Use of random numbers table Individual randomization, Blinding description: In general, this study will be blinded to individuals who are participated in data collection, outcome assessment and data analyzing, which means that they will not be aware of the intervention and the control groups. N/A Breast Cancer. Intervention 1: Intervention Group 1: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to a receive counseling group based on meta cognitive therapy for 14 sessions. Questionnaires of coping strategies, and fear of recurrence, quality of life, anxiety and depression, hope will be filled out before and after the intervention and after 2,4,8,12 months of follow-up. The information will then be entered into the software and data analysis will be performed and reported. Intervention 2: Intervention Group 1: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to a receive counseling group based on meta cognitive therapy (including spiritual therapy, meditation and yoga) for 14 sessions. Questionnaires of coping strategies, and fear of recurrence, quality of life, anxiety and depression, hope will be filled out before and after the intervention and after 2,4,8,12 months of follow-up. The information will then be entered into the software and data analysis will be performed and reported. Intervention 3: Control group: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to the control group for 14 sessions. Questionnaires of coping strategies, and fear of recurrence ,quality of life, anxiety and depression, hope will be filled out before and after the intervention in two intervention group, and after 2,4,8,12 months later. The information will then be entered into the software and data analysis will be performed and reported. They will be explained that they are in the control group and no intervention will be made for this group. However, if they wish to have counseling sessions, they will have them after accomplishment of the interventions and follow-up process. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I will make a decision later
public Akram Sajadian
No. 146, Gandi Ave, Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8879 7241 Assajadi@yahoo.com Iranian academic center for education culture and research scientific Akram Sajadian
No.146, Gandi Ave, Vanak Sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1517964311 +98 21 8879 7241 Assajadi@yahoo.com Iranian academic center for education culture and research Iran (Islamic Republic of) Pathology examination with definitive diagnosis of breast cancer Total accomplishment of breast cancer treatment local residency in Tehran and suburb Have ability to participate in meta-cognitive and trans-personal classes Having no medical history of psychiatric diseases Using no psychiatric medications Using no alternative methods of treatments such as yoga and meditation Not attending in classes similar with the present intervention Having informed consent to participate in the study 25 years 70 years Female Patients who are during their treatment Absence for two consecutive sessions Lack of desire to continue participating in the research The incidence of in-situ metastasis (carcinoma in-situ) in patients Patients who out of access during the intervention C50 Malignant neoplasm of breast Behavior Behavior Behavior Intervention Group 1: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to a receive counseling group based on meta cognitive therapy for 14 sessions. Questionnaires of coping strategies, and fear of recurrence, quality of life, anxiety and depression, hope will be filled out before and after the intervention and after 2,4,8,12 months of follow-up. The information will then be entered into the software and data analysis will be performed and reported. Intervention Group 1: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to a receive counseling group based on meta cognitive therapy (including spiritual therapy, meditation and yoga) for 14 sessions. Questionnaires of coping strategies, and fear of recurrence, quality of life, anxiety and depression, hope will be filled out before and after the intervention and after 2,4,8,12 months of follow-up. The information will then be entered into the software and data analysis will be performed and reported. Control group: Patients with breast cancer who who have completed their treatments and have lower average scores of coping, fear of recurrence and resilience. After careful information and having informed consent, 30 participants will be randomly assigned to the control group for 14 sessions. Questionnaires of coping strategies, and fear of recurrence ,quality of life, anxiety and depression, hope will be filled out before and after the intervention in two intervention group, and after 2,4,8,12 months later. The information will then be entered into the software and data analysis will be performed and reported. They will be explained that they are in the control group and no intervention will be made for this group. However, if they wish to have counseling sessions, they will have them after accomplishment of the interventions and follow-up process. Coping strategies ,fear of recurrence, quality of life, anxiety& depression, hope. Timepoint: Before the intervention, and at the end of the intervention and 2 months later, 4 months later, 8 month later,12 months later. Method of measurement: Coping strategies, cancer recurrence , Quality of Life Eortc30, Br23, HASD Anxiety and Depression, Beck Depression, Life expectancy Questionnaire. Resilience. Timepoint: Before the intervention, and at the end of the intervention and 2 months later, 4 months later, 8 month later,12 months later. Method of measurement: Resilience Questionnaire. Mean square of coping, mean square of fear of recurrence, mean square of quality of life, mean square of anxiety and depression, mean square of life expectancy. Timepoint: Before , after intervention and 2 month, 4month, 8month,12month later. Method of measurement: Questionnaire. Resilience. Timepoint: Before , after intervention and 2 month, 4month, 8month,12month later. Method of measurement: Questionnaire. Iranian academic center for education culture and research Approved 2020-01-12 Ethics committee of Kharazmi University No.146, Gandi Ave, Vanak Sq. Tehran.Iran. Tehran Tehran Iran (Islamic Republic of)