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IRCT20150608022609N7 IRCT 2020-04-01 Mazandaran University of Medical Sciences The effect of supportive program on caregiving burden and stress of husbands of women with breast cancer The effect of supportive program on spouses caregiver burden and stress in women suffer breast cancer undergoing chemotherapy 2020-05-21 anticipated 80 Complete https://irct.ir/trial/46827 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Other design features: There are two consequences in this study, Randomization description: In the absence of anxiety and depression, further explanations of how the study was conducted to evaluate participation in the informed and written consent study will be obtained from men. Then random allocation for participants is described. Moreover, ethical questions will be answered by participants who did not consent to participate in the study or who were eligible for the study but who were included in the control group. Are given. Afterwards, 80 eligible study caregivers who entered our study will be randomly divided into intervention and control groups. Therefore, 20 blocks and 4 blocks in each group were selected by software using permuted block randomization method. The number of intervention and control groups is equal in each block. In the following, 80 envelopes will be prepared to comply with the concealment principle and the specified groups will be divided into groups I and C in each envelope.The first envelope belongs to the first participant, whose content, based on previous blocking, will determine the task of participants of the entering the intervention or control group. N/A Caring burden and stress. Intervention group: Wives of women with breast cancer. 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 The research is not over yet
public seyedeh zeynabhoseinnazhad
Fish Field, beheshti 13
فریدونکنار Iran (Islamic Republic of) 4751813343 +98 11 3566 0005 zeynabhoseinnezhad@gmail.com Mazandaran University of Medical Sciences scientific Zohreh Shahhosseini
Nasibeh Nursing and Midwifery Faculty, Vesal Shirazi Avenue
sari Iran (Islamic Republic of) 4816715793 +98 11 3337 4750 Z.Shahhosseini@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Being Iranian Ability to read and write Ages between 25 to 60 years old Monogamy The first course of patient chemotherapy Stages 1 to 3 of the disease Patients undergoing chemotherapy (at least one chemotherapy session) Willingness to participate in the study Lack of psychiatric and psychological disorders in caregiver and patient No education in medical and paramedical fields Not using concurrent counseling or 6 months ago Absence of severe psychiatric disorder based on the individual history No depression and severe anxiety (according to the DASS-21 questionnaire) No current use of psychiatric drugs (such as antipsychotics, antidepressants and anxiolytics) No addiction 25 years 60 years Male The output criterion is not considered in this study Other Intervention group: Wives of women with breast cancer Caregiver burden measurement. Timepoint: Immediately after the intervention and 6 weeks later. Method of measurement: With the DASS questionnaire, mild to moderate grades are acceptable for men. Stress measurement. Timepoint: Immediately after the intervention and 6 weeks later. Method of measurement: Measure with CBT questionnaire. Scores below 72 (Mild to Medium) are acceptable. Quality of Life in Breast Cancer Patients. Timepoint: Immediately after the intervention and 6 weeks later. Method of measurement: Quality of life questionnaire for cancer patients, higher scores indicate better quality of life. Mazandaran University of Medical Sciences Approved 2020-03-30 Ethics Committee of Mazandaran University of Medical Sciences خیابان معلم، میدان معلم، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی مازندران sari Mazandaran Iran (Islamic Republic of)