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IRCT201210165987N6 IRCT 2013-06-13 Vice chancellor for research, Faculty of Nursing and Midwifery, Tehran University of Medical Science The effect of decision aid in patients with breast cancer The effect of decision aid package on selecting therapeutic option and decision outcomes among patients with early stage breast cancer 2012-09-22 anticipated 30 Complete https://irct.ir/trial/6450 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Breast cancer. Intervention 1: Intervention 2: Intervention group at the first visit after confirm the diagnosis by physician, to get decision aid package were referred to the research nurse. Decision aid Package includes a information booklet and audiotape and personal worksheet. Information booklet contains information about the disease, treatment options, advantages and disadvantages of each treatment and the effect of treatment on patient survival and quality of life and were informed the patients for choose of one of therapeutic options (mastectomy or lumpectomy with radiation). The audiotape was twenty-minute long and supplements the booklet. And personal worksheet was in order to record the final decision and any questions, comments or ambiguity of the patients after study package. The patients were asked to return to their doctor up to four days later, after consultation with the people their trusted and study package, to discuss their questions and announce their final decision on the therapeutic option. Telephone follow-up during this period until the return of the patients to prevent the withdrawal of the samples was performed by a research nurse. On the second visit, treatment option and decision conflict questionnaire was completed. Eight weeks after beginning treatment decision regret questionnaire was completed. Patients telephone follow-up was done every two weeks during this eight weeks. Intervention 2: Intervention 2: The control group were received routine care. Decision aid package was not given to this group. One to four days after the first visit (before beginning treatment) treatment option and decision conflict questionnaire was completed and eight weeks after treatment, decision regret questionnaire was completed.
public Seyyede Narjess Mousavizade
Tehran, Tohid sq, Nosrat street, Faculty of nursing and midwifery, Tehran University of Medical Science
Tehran Iran (Islamic Republic of) +98 21 6637 7579 mousavi201089@yahoo.com International Campus, Tehran University of Medical Sciences scientific Doctor Shahrzad Ghiyasvandiyan
Tehran, Tohid sq, Faculty of nursing and midwifery,Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 6642 0739 shghiyas@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: all case studies will sign an informed consent, and also they should have the following conditions: 1) Have clinical stage 1 or 2 breast cancer that be approved by the physician 2) Not have previous history of cancer. 3) Not have serious non-malignant diseases such as cardiovascular, respiratory, renal, which may prevent definitive surgery . 4) They should be literate. 5) They should have language of Persian dialects. 6) Not have mental disorder and addictions which preventing decision-making process and giving informed consent for participating in this study. Exclusion criteria: In this study, if a patient has one of following characteristics, it will be excluded from the study: 1) If patient requires to intensive care. 2) If patient dies or migrate (so that access to the patient is not possible). 3) If patient participate in other studies 21 years 78 years Female C50 Malignant neoplasm of breast Other Other Intervention 2: Intervention group at the first visit after confirm the diagnosis by physician, to get decision aid package were referred to the research nurse. Decision aid Package includes a information booklet and audiotape and personal worksheet. Information booklet contains information about the disease, treatment options, advantages and disadvantages of each treatment and the effect of treatment on patient survival and quality of life and were informed the patients for choose of one of therapeutic options (mastectomy or lumpectomy with radiation). The audiotape was twenty-minute long and supplements the booklet. And personal worksheet was in order to record the final decision and any questions, comments or ambiguity of the patients after study package. The patients were asked to return to their doctor up to four days later, after consultation with the people their trusted and study package, to discuss their questions and announce their final decision on the therapeutic option. Telephone follow-up during this period until the return of the patients to prevent the withdrawal of the samples was performed by a research nurse. On the second visit, treatment option and decision conflict questionnaire was completed. Eight weeks after beginning treatment decision regret questionnaire was completed. Patients telephone follow-up was done every two weeks during this eight weeks. Intervention 2: The control group were received routine care. Decision aid package was not given to this group. One to four days after the first visit (before beginning treatment) treatment option and decision conflict questionnaire was completed and eight weeks after treatment, decision regret questionnaire was completed. Select therapeutic option. Timepoint: One to four days after intervention. Method of measurement: O'Connor questionnaire. ِِDecision conflict. Timepoint: 1-4 days after intervention. Method of measurement: O'Connor traditional decisional conflict scale. Decision Regret. Timepoint: Eight weeks after intervention. Method of measurement: O'Connor Decision Regret Scale. Vice chancellor for research, Faculty of Nursing and Midwifery, Tehran University of Medical Science Approved 2012-09-30 Tehran University of Medical Sciences Ethics Committee Tehran, Keshavarz blvd, Ghods st. Tehran Iran (Islamic Republic of)