Comparison of the Effect of Self-Management of Lymphedema in Two Ways of Group and Social network based on the Quality of Life and Fear of Recurrence of Disease in Women With Breast Cancer.
Aim: Comparison of the Effect of Self-Management of Lymphedema in Two Ways of Group and Social network based on the Quality of Life and Fear of Recurrence of Disease in Women with Breast Cancer.
Design: randomized controlled clinical trial and not blinded
Population: All the women with lymphedema caused by breast cancer referring to the Lymphedema Clinic in Tehran.
Inclusion criteria: A record of confirmed cancer from phase 0 to 3, Having lymphedema confirmed by the doctor in the last recent year
Exclusion criteria: Not participating in the third and fourth sessions as the key sessions in the in-person group, Disapproval of receiving messages by the samples on Telegram™ twice a week in the based-on-the-social-network group
Sample size: 105 breast cancer survivors
Intervention:
After completing the sample size, another person puts the patients randomly by postcode lottery into the three groups of A, B and C (in-person interference, Telegram™ interference and control). Then, the researcher announces the group into which each patient is put to each of them separately. All the patients including the interference and control group will receive the routine trainings of the center. The members of the first interference group in seven groups of five will receive the self-management in-person training in five sessions of 60 minutes and, based on the needs of the patients, up to 90 minutes. In the interference group based on the social network, in the framework of a channel on Telegram™ the same educational content will be presented five times on different days in the afternoon hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052834176N1
Registration date:2017-08-21, 1396/05/30
Registration timing:prospective
Last update:
Update count:1
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
zahra omidi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 65577382
Email address
omidi.z@tak.iums.ac.ir
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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Self-Management of Lymphedema in Two Ways of Group and Social network based on the Quality of Life and Fear of Recurrence of Disease in Women With Breast Cancer.
Public title
teaching lymphedema self management in breast cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
- A record of confirmed cancer from phase 0 to 3
- Having lymphedema confirmed by the doctor in the last recent year
- Being between 18 and 55 years of age
- Completion of the remedies
- Reading and writing literacy
- Being skilled enough at using Telegram™
- Having access to the Internet and a cellphone
- No use of psychiatric treatments and psychological counseling after catching cancer
- No background in taking part in educational classes on the fear of recurrence cancer
- Negative tumor margin
- Being Iranian
Exclusion Criteria:
- Not participating in the third and fourth sessions as the key sessions in the in-person group
- Disapproval of receiving messages by the samples on Telegram™ twice a week in the based-on-the-social-network group
- Diagnosis of cancer recurrence in the study procedure
- In the event of a recurrence of cancer in the study period, the patient will remain in the group but their data will not be used in the study.
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran,Iran
City
Tehran
Postal code
1449614535
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-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
Secondary outcomes
empty
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 recurrence, 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, patients receive self-management trainings 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
Research units are required to fill out the questionnaires of the fear of cancer recurrence, the degree of the effect of lymphedema on life, and the questionnaires of the quality of life on patients with cancer and breast cancer immediately after the sessions are over and after three months.
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 recurrence, the effect of lymphedema on life, 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 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
Research units are required to fill out the questionnaires of the fear of cancer recurrence, the degree of the effect of lymphedema on life, and the questionnaires of the quality of life on patients with cancer and breast cancer immediately after the sessions are over and after three months.
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 recurrence, the effect of lymphedema on life 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. The research groups are required to fill out the questionnaires of the fear of cancer recurrence, the effect of lymphedema on life and the questionnaires of the evaluation of the quality of life in patients with cancer and breast cancer once the sessions are over 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
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical therapy clinic seyyed khandan
Full name of responsible person
shahpar haghighat
Street address
Building No. 17. South Abouzar St, Khajeh Abdollah Ansari St, Seyed Khandan Bridge, Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
school of nursing and midwifery
Street address
School of Nursing and Midwifery.Rashid Yasemi St.Valiasr St.Tehran- Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
PHD
Other areas of specialty/work
Street address
School of Nursing and Midwifery.Rashid Yasemi St.Valiasr St.Tehran- Iran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
Email
Masoomeh_kheirkhah2002@yahoo.com
Web page address
http://fnm.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
masomeh kheirkhah
Position
phd
Other areas of specialty/work
Street address
School of Nursing and Midwifery.Rashid Yasemi St.Valiasr St.Tehran- Iran
City
tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
+98 21 8820 1978
Email
fnm@iums.ac.ir
Web page address
http://fnm.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
zahra omidi
Position
Masters student
Other areas of specialty/work
Street address
School of Nursing and Midwifery.Rashid Yasemi St.Valiasr St.Tehran- Iran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Fax
+98 21 8820 1978
Email
fnm@iums.ac.ir
Web page address
http://fnm.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)