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IRCT20171105037237N2 IRCT 2018-12-21 Esfahan University of Medical Sciences The effect of group intervention based on the family (spouse or patient's primary caregiver) on quality of life and sense of coherence Comparison of the effectiveness of family based group therapy and self help group therapy on quality of life and sense of coherence in women with breast cancer after chemotherapy 2017-08-23 anticipated 80 Complete https://irct.ir/trial/27595 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 80 patients after chemotherapy and after obtaining informed consent were selected non randomly and easily among patients referring to the Isfahan Entekhab treatment center, and then randomly assigned to intervention and control groups using the random numbers table, Blinding description: The person responsible for collecting the questionnaires was not informed about which person was in the intervention group and who was in the control group, as well as the data was analyzed by the data analyst after the anonymity. The analyst did not know how the patients were allocated to the groups and the groups were name with an abbreviation name. 1-2 Breast Cancer. Intervention 1: Intervention group: family based group therapy.Patients in the intervention group participated in family-based group intervention sessions organized by the psychotherapist 2 months after chemotherapy in 10 90-minute sessions with their spouse or primary caregiver. Before and after the 10-session intervention, quality of life questionnaires or QOL-BR 23 and sense of autonomic integrity were filled in by patients with breast cancer. Intervention 2: Control group: Self help group therapy in which patients participated in the family-based group intervention sessions administered by the psychotherapist 2 months after chemotherapy in 10 sessions of 90 minutes without their primary caregiver. Before and after the 10-session intervention, quality of life questionnaires or QOL-BR 23 and sense of autonomic integrity were filled in by patients with breast cancer. Yes - There is a plan to make this available What will be shared: Information will be available after obtaining permission from the research deputy of the Isfahan University of Medical Sciences, two years after the publication of the article. When: Information will be available after obtaining permission from the research deputy of the Isfahan University of Medical Sciences, two years after the publication of the article. To whom: Cancer researchers, counselors, psychologists and physicians, and especially community health researchers Conditions: In order to compare the present studies with other similar studies or perform other statistical calculations, after coordination and permission from the vice chancellor of research of the Faculty of Medicine, Isfahan University of Medical Sciences, as well as sending a request to the email Parinazshirani@yahoo.com, information after the inescapable Identification is available to other researchers. Where to obtain: Send your email to Parinazshirani@yahoo.com with a clear and concise statement after coordinating and obtaining permission from the research deputy of the Faculty of Medicine, Isfahan University of Medical Sciences. How to obtain: Send your email to Parinazshirani@yahoo.com with a clear and concise statement after coordinating and obtaining permission from the research deputy of the Faculty of Medicine, Isfahan University of Medical Sciences. Comments:
public Parinaz Shirani
No.40 , 17 alley, Freiburg street
Isfahan Iran (Islamic Republic of) 8168754944 +98 31 3668 4827 Parinazshirani@yahoo.com Esfahan University of Medical Sciences scientific Parinaz Shirani
No.40, 17 alley, Freiburg street
Isfahan Iran (Islamic Republic of) 8168754944 +98 31 3668 4827 Parinazshirani@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Women with Breast Cancer Stage 3 and 4 Obtain informed consent Have reading and writing skills Patients at the age of 18-60 years old 18 years 60 years Female Having diagnostic criteria for psychiatric disorders such as psychosis and personality disorders by taking a history Having another physical illness that prevents a person from participating in the research program Participate in spiritual therapy sessions or therapies C50 Malignant neoplasm of breast Treatment - Other Treatment - Other Intervention group: family based group therapy.Patients in the intervention group participated in family-based group intervention sessions organized by the psychotherapist 2 months after chemotherapy in 10 90-minute sessions with their spouse or primary caregiver. Before and after the 10-session intervention, quality of life questionnaires or QOL-BR 23 and sense of autonomic integrity were filled in by patients with breast cancer. Control group: Self help group therapy in which patients participated in the family-based group intervention sessions administered by the psychotherapist 2 months after chemotherapy in 10 sessions of 90 minutes without their primary caregiver. Before and after the 10-session intervention, quality of life questionnaires or QOL-BR 23 and sense of autonomic integrity were filled in by patients with breast cancer. Quality of life. Timepoint: At three periods including before the intervention, immediately after the end of the 10th training session and 3 months after the end of the intervention (after the tenth session). Method of measurement: EORTC-QLO-BR 23 Quality of Life Questionnaire. Sense of coherence. Timepoint: At three periods including before the intervention, immediately after the end of the 10th training session and 3 months after the end of the intervention (after the tenth session). Method of measurement: Antonovsky Sense of Sensitivity Questionnaire (SOC-13). Esfahan University of Medical Sciences Approved 2017-06-20 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences & Health Services,Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)