Protocol summary
-
Study aim
-
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.
-
Design
-
Three-group clinical trial with control group, randomized by assigning 105 women with lymphedema to group-based education (n = 35), social network- based education (n = 35) and control group (n = 35) using a random block method.
-
Settings and conduct
-
The study was conducted on women with lymphedema referring in Seyyed-e-Khandan physiotherapy institute in Tehran as a randomized clinical trial.
-
Participants/Inclusion and exclusion criteria
-
History of breast cancer stages 0 to IV, lymphedema approved by physician during the last year, age 18-65, treatments completion, ability to read and write, and work with Telegram, access to the Internet and a cellphone, no use of psychiatric treatments and psychological counseling after catching cancer, negative tumor margin, being Iranian.
-
Intervention groups
-
Group-based education was conducted in 7 groups of 5 subjects in 5 sessions 60 to 90 minutes 2 times a week for 3 weeks. At the end of the sessions, CD containing educational materials was given to the participants. Social network-based education was presented 5 times and 2 times a week for 3 weeks on a channel in application of Telegram™. All participants received usual treatment (20 sessions complete decongestive therapy). The control group were completed the questionnaires at the beginning of the study, immediately after the usual treatment and three months later. At the end of the intervention, CD containing educational materials was given to the participants in control group.Before the intervention, immediately and three months after the intervention questionnaires were completed by participants in intervention groups.
-
Main outcome variables
-
Quality of life; fear of cancer recurrence
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2017052834176N1
Registration date:
2017-08-21, 1396/05/30
Registration timing:
prospective
Last update:
2019-05-11, 1398/02/21
Update count:
1
-
Registration date
-
2017-08-21, 1396/05/30
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Iran University of Medical Sciences
-
Expected recruitment start date
-
2017-08-23, 1396/06/01
-
Expected recruitment end date
-
2018-03-19, 1396/12/28
-
Actual recruitment start date
-
2017-09-23, 1396/07/01
-
Actual recruitment end date
-
2018-03-17, 1396/12/26
-
Trial completion date
-
2018-06-20, 1397/03/30
-
Scientific title
-
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.
-
Public title
-
teaching lymphedema self management in breast cancer patients
-
Purpose
-
Education/Guidance
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
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
Exclusion criteria:
Metastasis
A history of cancer recurrence
-
Age
-
From 18 years old to 65 years old
-
Gender
-
Female
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
105
Actual sample size reached:
105
-
Randomization (investigator's opinion)
-
Randomized
-
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.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-03-11, 1395/12/21
-
Ethics committee reference number
-
ir.iums.rec1395.9411373002
Health conditions studied
1
-
Description of health condition studied
-
Breast cancer
-
ICD-10 code
-
C50
-
ICD-10 code description
-
Malignant neoplasm of breast
2
-
Description of health condition studied
-
lymphedema
-
ICD-10 code
-
I97.2
-
ICD-10 code description
-
Postmastectomy lymphoedema syndrome
Primary outcomes
1
-
Description
-
quality of life
-
Timepoint
-
before,Immediately, 3 months after intervention
-
Method of measurement
-
questionnaires of QLQ-BR23,QLQC30 and LLIS
2
-
Description
-
fear of recurrence cancer
-
Timepoint
-
before,Immediately, 3 months after intervention
-
Method of measurement
-
short form of fear of progression questionnaire
Intervention groups
1
-
Description
-
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.
-
Category
-
Behavior
2
-
Description
-
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.
-
Category
-
Behavior
3
-
Description
-
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.
-
Category
-
Behavior
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Iran University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
No more information
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available