History
# Registration date Revision Id
2 2020-12-19, 1399/09/29 164098
1 2020-06-20, 1399/03/31 139748
Changes made to previous revision
  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents
  • Protocol summary

    Determining the effectiveness of group consulting based on meta-cognitive therapy on coping strategies and fear of recurrence, resilience in patients with breast cancer Determining the effectiveness of group counseling based on transpersonal therapy on coping strategies & fear of recurrence , resilience for patients with breast cancer Comparison the effectiveness of group consulting based on meta-cognitive therapy and interpersonal therapy on coping strategies and fear of recurrence , resilience in patients with breast cancer
    Determining the effectiveness of group consulting based on meta-cognitive therapy on anxiety, depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors. Determining the effectiveness of group counseling based on transpersonal therapy on anxiety, depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors. Comparison the effectiveness of group consulting based on meta-cognitive therapy and interpersonal therapy on anxiety and depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors.
    تعیین میزان اثر بخشی مشاوره گروهی مبتنی بر درمان فراشناختی بر راهبردهای مقابله ای و ترس از عود بیماران مبتلا به سرطان پستان تعیین میزان اثر بخشی مشاوره گروهی مبتنی بر درمان فرافردی بر راهبردهای مقابله ای و ترس از عود و تاب اوری بیماران مبتلا به سرطان پستان مقایسه اثر بخشی مشاوره گروهی مبتنی بر درمان فراشناختی و درمان فرافردی بر راهبردهای مقابله ای وترس از عود بیماران مبتلا به سرطان پستان
    تعیین میزان اثر بخشی مشاوره گروهی مبتنی بر درمان فراشناختی بر اضطراب و افسردگی، راهبردهای مقابله ای ،امید، تاب اوری، کیفیت زندگی و ترس از عود بیماران مبتلا به سرطان پستان تعیین میزان اثر بخشی مشاوره گروهی مبتنی بر درمان فرافردی بر اضطراب و افسردگی، راهبردهای مقابله ای ،امید، تاب اوری، کیفیت زندگی و ترس از عود بیماران مبتلا به سرطان پستان مقایسه اثر بخشی مشاوره گروهی مبتنی بر درمان فراشناختی و درمان فرافردی بر اضطراب و افسردگی، راهبردهای مقابله ای ،امید، تاب اوری، کیفیت زندگی وترس از عود بیماران مبتلا به سرطان پستان
    پس از غربالگری اولیه بیمارانی که درمان آنها کامل شده است، با روش تصادفی ساده 36 نفر با رضایت در 3 گروه اختصاص می یابند. سپس 2گروه به طور مستقل مداخلات فراشناختی و فرافردی دریافت میکنند. یک گروه به عنوان کنترل در نظر گرفته می شود. مراقبان، تحلیگران داده از مداخلات بی خبرند.
    پس از غربالگری اولیه بیمارانی که درمان آنها کامل شده است، با روش تصادفی ساده 90 نفر با رضایت در 3 گروه اختصاص می یابند. سپس 2گروه به طور مستقل مداخلات فراشناختی و فرافردی دریافت میکنند. یک گروه به عنوان کنترل در نظر گرفته می شود. مراقبان، تحلیگران داده از مداخلات بی خبرند.
    Pathology examination with definitive diagnosis of breast cancer Total accomplishment of breast cancer treatment 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 Exclusion criteria: Patients who are during their treatment process being treated or local metastasized on or off during interventions Absence for two consecutive sessions Lack of desire to continue participating in the research
    Pathology examination with definitive diagnosis of breast cancer Total accomplishment of breast cancer treatment 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 Exclusion criteria: Patients during treatment Absence for two consecutive sessions Lack of desire to continue participating in the research
    -coping strategies -fear of recurrence
    Coping strategies, Fear of recurrence, Quality of Life, Anxiety and depression, Hope
    -راهبردهای مقابله ای -ترس از عود
    -راهبردهای مقابله ای -ترس از عود - کیفیت زندگی -اضطراب و افسردگی -امید
  • General information

    Not randomized
    Randomized
    1
    36
    90
    empty
    Increase study results
    empty
    افزایش پیامدهای مطالعه
    Comparison of the effectiveness of group consulting based on meta-cognitive therapy and trans-personal therapy on coping strategies ، fear of recurrence and resilience in patients with 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
    مقایسه اثر بخشی مشاوره گروهی مبتنی بر درمان فراشناختی و درمان فرافردی بر راهبردهای مقابله ای، ترس از عود و تاب آوری بیماران مبتلا به سرطان پستان
    مقایسه اثر بخشی مشاوره گروهی مبتنی بر درمان فراشناختی و درمان فرافردی بر راهبردهای مقابله ای، ترس از عود، کیفیت زندگی، اضطراب و افسردگی، امید و تاب آوری بقایافتگان به سرطان پستان
    Patients who are during their treatment process being treated or local metastasized on or off during interventions
    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
    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
    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
    بازماندگان سرطان پستان از چند مرکز درمانی پس از درمان کامل دعوت به همکاری می شوند. سپس دراولین مراجعه به کلینیک پیگیری ، کسانی که برای شرکت در مداخله فرم رضایت آگاهانه را پر کردند ثبت نام شده و با استفاده از جدول اعداد تصادفی به طور تصادفی برای یکی از سه گروه مطالعه اختصاص داده می شوند. استفاده از جدول اعداد تصادفی واحد تصادفی سازی فردی
  • Primary outcomes

    #1
    Coping strategies ,fear of recurrence
    Coping strategies ,fear of recurrence, quality of life, anxiety& depression, hope
    راهبردهای مقابله ای، ترس از عود
    راهبردهای مقابله ای، ترس از عود، کیفیت زندگی، اضطراب و افسردگی، امید
    Before the intervention, and at the end of the 2-month intervention
    Before the intervention, and at the end of the intervention and 2 months later, 4 months later, 8 month later,12 months later
    قبل از درمان و در انتهای مداخله و 2 ماهه بعد
    قبل از درمان و در انتهای مداخله و 2 ماهه بعد،4 ماه بعد،8 ماه بعد ، 12 ماه بعد
    Coping strategies, cancer recurrence Questionnaire
    Coping strategies, cancer recurrence , Quality of Life Eortc30, Br23, HASD Anxiety and Depression, Beck Depression, Life expectancy Questionnaire
    پرسشنامه سازگاری، ترس ازعود
    پرسشنامه سازگاری، ترس ازعود، کیفیت زندگیEortc30,Br23،اضطاب و افسردگی HASD، افسردگی بک، امید به زندگی اشنایدر
    #2
    Before the intervention, and at the end of the 2-month intervention
    Before the intervention, and at the end of the intervention and 2 months later, 4 months later, 8 month later,12 months later
    قبل از مداخله، در پایان مداخله و دو ماه بعد
    قبل از مداخله، در پایان مداخله و دو ماه بعد،4 ماه بعد،8 ماه بعد ، 12 ماه بعد
  • Secondary outcomes

    #1
    Mean square of coping, mean square of fear of recurrence
    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.
    نمره سازگاری ، نمره ترس ازعود
    نمره سازگاری ، نمره ترس ازعود، نمره کیفیت زندگی، نمره اضطراب و افسردگی، نمره امید به زندگی
    Before , after intervention and 2 month later
    Before , after intervention and 2 month, 4month, 8month,12month later.
    قبل و بعد از مداخله و 2 ماه بعد
    قبل و بعد از مداخله و 2 ماه بعد، 4 ماه بعد، 8 ماه بعد، 12 ماه بعد
    #2
    Before , after intervention and 2 month later
    Before , after intervention and 2 month, 4month, 8month,12month later.
    قبل و بعد از مداخله و 2 ماه بعد
    قبل و بعد از مداخله و 2 ماه بعد، 4 ماه بعد، 8 ماه بعد، 12 ماه بعد
  • Intervention groups

    #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, 12 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 will be filled out before and after the intervention and after 2 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 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.
    گروه مداخله1: بیماران مبتلا به سرطان پستان که درمان خود را کامل کرده باشند و میانگین نمره سازگاری، و ترس ا زعود پایین داشته باشند. پس ازاطلاع رسانی دقیق و رضایت آگاهانه 12 نفر به طور تصادفی به گروه مشاوره مبتنی بر درمان فراشناختی اختصاص یافته و به مدت 14 جلسه ادامه خواهد داشت. پس از مداخله مجدد پرسشنامه های سازگاری و ترس از عود وتاب آوری پرشده و 2 ماه بعد نیز در جلسه پی گیری فرم ها مجددا پرشده و سپس اطلاعات وارد نرم افزار شده و تحلیل داده ها انجام و گزارش می شود.
    گروه مداخله1: بیماران مبتلا به سرطان پستان که درمان خود را کامل کرده باشند و میانگین نمره سازگاری، و ترس ا زعود پایین داشته باشند. پس ازاطلاع رسانی دقیق و رضایت آگاهانه 30نفر به طور تصادفی به گروه مشاوره مبتنی بر درمان فراشناختی اختصاص یافته و به مدت 14 جلسه ادامه خواهد داشت. پس از مداخله مجدد پرسشنامه های سازگاری و ترس از عود وتاب آوری ،کیفیت زندگی، اضطراب و افسردگی، امید پرشده 2 و 4و8 و12 ماه بعد نیز در جلسات پی گیری فرم ها مجددا پرشده و سپس اطلاعات وارد نرم افزار شده و تحلیل داده ها انجام و گزارش می شود.
    #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, 12 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 will be filled out before and after the intervention and after 2 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.
    گروه مداخله۲: بیماران مبتلا به سرطان پستان که درمان خود را کامل کرده باشند و میانگین نمره سازگاری، و ترس ا زعود پایین داشته باشند. پس ازاطلاع رسانی دقیق و رضایت آگاهانه 12 نفر به طور تصادفی به گروه مشاوره مبتنی بر درمان فرافردی( شامل معنویت درمانی، مدیتیشن و یوگا) اختصاص یافته و به مدت 14 جلسه ادامه خواهد داشت. پس از مداخله مجدد پرسشنامه های سازگاری و ترس از عود وتاب آوری پرشده و 2 ماه بعد نیز در جلسه پی گیری فرم ها مجددا پرشده و سپس اطلاعات وارد نرم افزار شده و تحلیل داده ها انجام و گزارش می شود.
    گروه مداخله۲: بیماران مبتلا به سرطان پستان که درمان خود را کامل کرده باشند و میانگین نمره سازگاری، و ترس ا زعود پایین داشته باشند. پس ازاطلاع رسانی دقیق و رضایت آگاهانه 30نفر به طور تصادفی به گروه مشاوره مبتنی بر درمان فرافردی( شامل معنویت درمانی، مدیتیشن و یوگا) اختصاص یافته و به مدت 14 جلسه ادامه خواهد داشت. پس از مداخله مجدد پرسشنامه های سازگاری و ترس از عود وتاب آوری، کیفیت زندگی، اضطراب و افسردگی، امید پرشده و 2 و 4و8 و12 ماه بعد نیز در جلسات پی گیری فرم ها مجددا پرشده و سپس اطلاعات وارد نرم افزار شده و تحلیل داده ها انجام و گزارش می شود.
    #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, 12 participants will be randomly assigned to the control group for 14 sessions. Questionnaires of coping strategies, and fear of recurrence will be filled out before and after the intervention and after 2 months of follow-up. 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.
    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.
    گروه کنترل: بیماران مبتلا به سرطان پستان که درمان خود را کامل کرده باشند و میانگین نمره سازگاری، و ترس ا زعود پایین داشته باشند. پس ازاطلاع رسانی دقیق و رضایت آگاهانه 12 نفر به طور تصادفی به گروه کنترل اختصاص یافته و به مدت 14 جلسه ادامه خواهد داشت. پس از مداخله مجدد پرسشنامه های سازگاری و ترس از عود وتاب آوری پرشده و 2 ماه بعد نیز در جلسه پی گیری فرم ها مجددا پرشده و سپس اطلاعات وارد نرم افزار شده و تحلیل داده ها انجام و گزارش می شود. برای این گروه توضیح داده می شود که در گروه کنترل قرار دارند و هیچ مداخله ای برای این گروه انجام نمی شود. البته چنانچه مایل به دریافت جلسات مشاوره باشند، پس از اتمام مداخلات و پی گیری، مشاوره برایشان انجام می شود
    گروه کنترل: بیماران مبتلا به سرطان پستان که درمان خود را کامل کرده باشند و میانگین نمره سازگاری، و ترس ا زعود پایین داشته باشند. پس ازاطلاع رسانی دقیق و رضایت آگاهانه 30نفر به طور تصادفی به گروه کنترل اختصاص یافته و به مدت 14 هفته فاصله ادامه خواهد داشت. پس از اتمام مداخله گروه های مداخله، مجدد پرسشنامه های سازگاری و ترس از عود وتاب آوری، کیفیت زندگی، اضطراب و افسردگی، امید پرشده و 2 و 4و8 و12 ماه بعد نیز در جلسات پی گیری فرم ها مجددا پرشده و سپس اطلاعات وارد نرم افزار شده و تحلیل داده ها انجام و گزارش می شود. برای این گروه توضیح داده می شود که در گروه کنترل قرار دارند و هیچ مداخله ای برای این گروه انجام نمی شود. البته چنانچه مایل به دریافت جلسات مشاوره باشند، پس از اتمام مداخلات و پی گیری، مشاوره برایشان انجام می شود
  • Recruitment centers

    #1
    Name of recruitment center - English: Motamed Cancer Institute
    Name of recruitment center - Persian: مرکز تحقیقات سرطان معتمد
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Street address - English: no.146. Gandi Ave. Vanak Sq. Tehran. Iran
    Street address - Persian: تهران. میدان ونک . نبش گاندی جنوبی. پ 146 . پژوهشکده سرطان معتمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7246
    Fax:
    Email: assajadi@yahoo.com
    Web page address:
    Name of recruitment center - English: Motamed Cancer Institute
    Name of recruitment center - Persian: مرکز تحقیقات سرطان معتمد
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Street address - English: No.146. Gandi Ave. Vanak Sq. Tehran. Iran
    Street address - Persian: تهران. میدان ونک . نبش گاندی جنوبی. پ 146 . پژوهشکده سرطان معتمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7246
    Fax:
    Email: Assajadi@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Street address - English: No.146. Gandi Ave. Vanak Sq.
    Street address - Persian: تهران . میدان ونک . نبش خ گاندی جنوبی. پ 146. پژوهشکده معتمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7246
    Fax:
    Email: assajadi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Street address - English: No.146. Gandi Ave. Vanak Sq.
    Street address - Persian: تهران . میدان ونک . نبش خ گاندی جنوبی. پ 146. پژوهشکده معتمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7246
    Fax:
    Email: Assajadi@yahoo.com
    Web page address:
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Position - English: Assistant professor
    Position - Persian: استادیار هیات علمی
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 146. Gandi Ave. Vanak Sq.
    Street address - Persian: تهران. میدان ونک . خ گاندی جنوبی. پ 146. پژوهشکده معتمد جهاددانشگاهی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7241
    Mobile: +98 912 819 8219
    Fax:
    Email: Assajadi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Position - English: Assistant professor
    Position - Persian: استادیار هیات علمی
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No. 146, Gandi Ave, Vanak Sq, Tehran, Iran
    Street address - Persian: تهران. میدان ونک . خ گاندی جنوبی. پ 146. پژوهشکده معتمد جهاددانشگاهی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7241
    Mobile: +98 912 819 8219
    Fax:
    Email: Assajadi@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Position - English: Assistant professor
    Position - Persian: مربی هیات علمی
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.146 Gandi Ave. Vanak Sq.
    Street address - Persian: تهران. میدان ونک. گاندی جنوبی پ 146. پژوهشکده معتمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7241
    Mobile: +98 912 819 8219
    Fax:
    Email: Assajadi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Position - English: Assistant professor
    Position - Persian: مربی هیات علمی
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.146, Gandi Ave, Vanak Sq, Tehran, Iran
    Street address - Persian: تهران. میدان ونک. گاندی جنوبی پ 146. پژوهشکده معتمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7241
    Mobile: +98 912 819 8219
    Fax:
    Email: Assajadi@yahoo.com
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Position - English: Assistant professor
    Position - Persian: مربی هیات علمی
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.146 Gandi Ave. Vanak Sq.
    Street address - Persian: تهران. میدان ونک. گاندی جنوبی پ 146. پژوهشکده معتمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7241
    Mobile: +98 912 819 8219
    Fax:
    Email: Assajadi@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Akram Sajadian
    Full name of responsible person - Persian: اکرم السادات سجادیان
    Position - English: Assistant professor
    Position - Persian: مربی هیات علمی
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No.146, Gandi Ave, Vanak Sq, Tehran, Iran
    Street address - Persian: تهران. میدان ونک. گاندی جنوبی پ 146. پژوهشکده معتمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1517964311
    Phone: +98 21 8879 7241
    Mobile: +98 912 819 8219
    Fax:
    Email: Assajadi@yahoo.com
    Web page address:

Protocol summary

Study aim
Determining the effectiveness of group consulting based on meta-cognitive therapy on anxiety, depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors. Determining the effectiveness of group counseling based on transpersonal therapy on anxiety, depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors. Comparison the effectiveness of group consulting based on meta-cognitive therapy and interpersonal therapy on anxiety and depression, coping strategies, hope, resilience, quality of life and fear of recurrence of breast cancer survivors.
Design
Parallel randomized single blind controlled clinical trial.
Settings and conduct
After screening patients who had completed their treatments, 36 patients will be randomized into 3 groups using simple randomization. Then, 2 groups will receive meta cognitive and trans personal interventions, separately. Data collectors and data analyzers are unaware of the interventions
Participants/Inclusion and exclusion criteria
Pathology examination with definitive diagnosis of breast cancer Total accomplishment of breast cancer treatment 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 Exclusion criteria: Patients during treatment Absence for two consecutive sessions Lack of desire to continue participating in the research
Intervention groups
Counseling sessions will be conducted in 14 sessions of 2 hours for participants in tow intervention group. Also, Control group will be performed for participants.
Main outcome variables
Coping strategies, Fear of recurrence, Quality of Life, Anxiety and depression, Hope

General information

Reason for update
Increase study results
Acronym
IRCT registration information
IRCT registration number: IRCT20200422047170N1
Registration date: 2020-06-20, 1399/03/31
Registration timing: prospective

Last update: 2020-12-22, 1399/10/02
Update count: 1
Registration date
2020-06-20, 1399/03/31
Registrant information
Name
Akram Sajadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 7246
Email address
assajadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of psychotherapy on the side effects of breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 25 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kharazmi University
Street address
No.146, Gandi Ave, Vanak Sq. Tehran.Iran.
City
Tehran
Province
Tehran
Postal code
1517964311
Approval date
2020-01-12, 1398/10/22
Ethics committee reference number
IR.KHU.REC.1398.057

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
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

2

Description
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

Secondary outcomes

1

Description
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

2

Description
Resilience
Timepoint
Before , after intervention and 2 month, 4month, 8month,12month later.
Method of measurement
Questionnaire

Intervention groups

1

Description
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.
Category
Behavior

2

Description
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.
Category
Behavior

3

Description
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.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Motamed Cancer Institute
Full name of responsible person
Akram Sajadian
Street address
No.146. Gandi Ave. Vanak Sq. Tehran. Iran
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 7246
Email
Assajadi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Akram Sajadian
Street address
No.146. Gandi Ave. Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 7246
Email
Assajadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Akram Sajadian
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 146, Gandi Ave, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 7241
Email
Assajadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Akram Sajadian
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.146, Gandi Ave, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 7241
Email
Assajadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Akram Sajadian
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.146, Gandi Ave, Vanak Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1517964311
Phone
+98 21 8879 7241
Email
Assajadi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...