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IRCT2017052834176N1 IRCT 2017-08-21 Iran University of Medical Sciences teaching lymphedema self management in breast cancer patients Comparison of the Effect of Lymphedema Self-Management Education in Two Methods of Group-Based and Social-Network-Based on Quality of Life and Fear of Disease Recurrence in Women With Breast Cancer. 2017-08-23 anticipated 105 Complete https://irct.ir/trial/26182 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling was done continuously. Before the intervention 35 sets from ABC, BAC, ... with numbers 1-35 by software was randomly produced.Every three women who entered the study assigned in one of the sets. Given that group education should be provided in groups of 5 people, every five people who entered the group-based education were received the intervention.The phone numbers of women who entered the social network-based education group were recorded to enter the Telegram channel after completing the sample size. Women who assigned to the control group were asked to complete questionnaire in the beginning, immediately after the usual treatment and three months after. N/A Condition 1: Breast cancer. Condition 2: lymphedema. Intervention 1: In the in-person interference group which consists of 35 people, after filling out the written consent form, the questionnaires of the fear of cancer progression, the effect of lymphedema on life, and the Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) and it’s supplementary Breast Cancer-Specific Quality of life questionnaire (QLQ_BR23) are filled out by people. In seven groups of five people, patients receive self-management training in five sessions in the form of speech, group discussion and question and answer which last as long as 60 minutes, and based on the patients’ need for question and answer, as long as 90 minutes. At the end of the interference sessions, the CDs containing the educational materials are given to be reviewed at home. The educational content is as follows:First session: preventing stress, fear and the anxiety caused by breast cancer with a focus on lymphedema Second session: general skills for self-management Third session: problem-solving skill with an explanation on lymphedema and its side effects, ways to control lymphedema and the phases of the self-management of lymphedema (the second phase of the standard treatment of lymphedema) Fourth session: decision making and the use of resources with an explanation on which phase of self-management ought to be utilized according to their own condition Fifth session: cooperation with the treatment team and the implementation of the learned skills at home. Participants are required to fill out the questionnaires immediately after the intervention and after three months.All people will also receive the usual treatment. Intervention 2: In the interference group based on the social network which consists of 35 people, after filling out the written consent form, the questionnaires of the fear of cancer progression, lymphedema life impact scale, and Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) and it’s supplementary Breast Cancer-Specific Quality of life questionnaire (QLQ_BR23) are filled out by people. To preserve the patients’ privacy and their numbers, on a Telegram™-based channel the same educational content are taught five times on different days in the afternoon hours. Channel members can pose their questions and answers with the administrator of the channel (i.e. the researcher). Also, after posing the content, to make sure of receiving messages from all the members, they are each required to inform the administrator of the channel or give their opinion(s) after receiving the content. Members are reminded to use Telegram™ software through SMS twice a week. The educational content is as follows:First session: preventing stress, fear and the anxiety caused by breast cancer with a focus on lymphedemaSecond session: general skills for self-managementThird session: problem-solving skill with an explanation on lymphedema and its side effects, ways to control lymphedema and the phases of the self-management of lymphedema (the second phase of the standard treatment of lymphedema)Fourth session: decision making and the use of resources with an explanation on which phase of self-management ought to be utilized according to their own conditionFifth session: cooperation with the treatment team and the implementation of the learned skills at home. Participants are required to fill out the questionnairesr immediately after the intervention and after three months.All people will also receive the usual treatment. Intervention 3: In the control group which consists of 35 patients, after filling out the written consent form, the questionnaires of the fear of cancer progression, lymphedema life impact scale and Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) and it’s supplementary Breast Cancer-Specific Quality of life questionnaire (QLQ_BR23) will be filled out by people. All the members of the control group will receive the routine trainings of the center including the care and prevention of lymphedema brochure and the CDs of rehabilitative sports for lymphedema which are routinely given to the clients and 20 sessions of complete decongestive therapy . Participants required to fill out the questionnaires immediately after the usual treatment and three months later. After collecting the data, the materials and educational CD will also be at the disposal of the control group members. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Masoomeh Kheirkhah
School of Nursing and Midwifery.Rashid Yasemi St.Valiasr St.Tehran- Iran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8820 8195 Kheirkhah.m@iums.ac.ir Iran University of Medical Sciences scientific Masomeh Kheirkhah
School of Nursing and Midwifery.Rashid Yasemi St.Valiasr St.Tehran- Iran
Tehran Iran (Islamic Republic of) 1996713883 +98 21 8820 8195 Kheirkhah.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Approved breast cancer stages 0 to IV Lymphedema of upper limb approved by physician during the last year Age between 18-65 Treatment completion Having literacy reading and writing The ability to work with Telegram™ via a laptop or mobile phone Having access to the Internet and a cellphone No use of psychiatric treatments and psychological counseling after catching cancer Negative tumor margin Being Iranian 18 years 65 years Female Metastasis A history of cancer recurrence C50 I97.2 Malignant neoplasm of breast Postmastectomy lymphoedema syndrome Behavior Behavior Behavior In the in-person interference group which consists of 35 people, after filling out the written consent form, the questionnaires of the fear of cancer progression, the effect of lymphedema on life, and the Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) and it’s supplementary Breast Cancer-Specific Quality of life questionnaire (QLQ_BR23) are filled out by people. In seven groups of five people, patients receive self-management training in five sessions in the form of speech, group discussion and question and answer which last as long as 60 minutes, and based on the patients’ need for question and answer, as long as 90 minutes. At the end of the interference sessions, the CDs containing the educational materials are given to be reviewed at home. The educational content is as follows:First session: preventing stress, fear and the anxiety caused by breast cancer with a focus on lymphedema Second session: general skills for self-management Third session: problem-solving skill with an explanation on lymphedema and its side effects, ways to control lymphedema and the phases of the self-management of lymphedema (the second phase of the standard treatment of lymphedema) Fourth session: decision making and the use of resources with an explanation on which phase of self-management ought to be utilized according to their own condition Fifth session: cooperation with the treatment team and the implementation of the learned skills at home. Participants are required to fill out the questionnaires immediately after the intervention and after three months.All people will also receive the usual treatment. In the interference group based on the social network which consists of 35 people, after filling out the written consent form, the questionnaires of the fear of cancer progression, lymphedema life impact scale, and Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) and it’s supplementary Breast Cancer-Specific Quality of life questionnaire (QLQ_BR23) are filled out by people. To preserve the patients’ privacy and their numbers, on a Telegram™-based channel the same educational content are taught five times on different days in the afternoon hours. Channel members can pose their questions and answers with the administrator of the channel (i.e. the researcher). Also, after posing the content, to make sure of receiving messages from all the members, they are each required to inform the administrator of the channel or give their opinion(s) after receiving the content. Members are reminded to use Telegram™ software through SMS twice a week. The educational content is as follows:First session: preventing stress, fear and the anxiety caused by breast cancer with a focus on lymphedemaSecond session: general skills for self-managementThird session: problem-solving skill with an explanation on lymphedema and its side effects, ways to control lymphedema and the phases of the self-management of lymphedema (the second phase of the standard treatment of lymphedema)Fourth session: decision making and the use of resources with an explanation on which phase of self-management ought to be utilized according to their own conditionFifth session: cooperation with the treatment team and the implementation of the learned skills at home. Participants are required to fill out the questionnairesr immediately after the intervention and after three months.All people will also receive the usual treatment. In the control group which consists of 35 patients, after filling out the written consent form, the questionnaires of the fear of cancer progression, lymphedema life impact scale and Iranian version of the European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ-C30) and it’s supplementary Breast Cancer-Specific Quality of life questionnaire (QLQ_BR23) will be filled out by people. All the members of the control group will receive the routine trainings of the center including the care and prevention of lymphedema brochure and the CDs of rehabilitative sports for lymphedema which are routinely given to the clients and 20 sessions of complete decongestive therapy . Participants required to fill out the questionnaires immediately after the usual treatment and three months later. After collecting the data, the materials and educational CD will also be at the disposal of the control group members. Quality of life. Timepoint: before,Immediately, 3 months after intervention. Method of measurement: questionnaires of QLQ-BR23,QLQC30 and LLIS. Fear of recurrence cancer. Timepoint: before,Immediately, 3 months after intervention. Method of measurement: short form of fear of progression questionnaire. Iran University of Medical Sciences Approved 2017-03-11 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,Iran Tehran Tehran Iran (Islamic Republic of)