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"Effect of education via educational SMS(short message sending) on self care and quality of life in cancer patients"

Protocol summary

Study aim
Determining the effect of SMS on self-care and quality of life of cancer patients
Design
Participants were divided into two groups of interventions (A) and control(B) through block randomized allocation.
Settings and conduct
Participants in control group will complete demographic, self care knowledge and behavior, and quality of life questionnaires and receive routine care. Participants in intervention group will complete all questionnaires, and in addition to receive routine care, will receive text messages about nutrition, increasing hope, decreasing anxiety, depression, fatigue and nausea, prevention of infection and bleeding, prevention and care of mucositis, and the importance of regular visits and follow up, for one month. Then the data collection will be performed in two more stages in both groups two weeks and one month after starting the study. The data will be analyzed. The research environment will be Ayatullah Khansari Hospital. .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18-45 years, having a mobile phone with the ability to receive text message, having the ability to read, individuals with gastrointestinal cancer without metastasis, chemotherapy will be continue at least one month after the start of the study. Exclusion criteria: If the patient died during the intervention, unable to continue participation in the study due to acute complications of cancer and its treatments, increasing the severity of the disease in the patient.
Intervention groups
Intervention group, in addition to routine care, will receive messages about nutrition, increasing hope, decreasing anxiety and depression and self care for one month.
Main outcome variables
Self-care behaviors and quality of life

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20121016011136N4
Registration date: 2018-05-27, 1397/03/06
Registration timing: retrospective

Last update: 2018-05-27, 1397/03/06
Update count: 0
Registration date
2018-05-27, 1397/03/06
Registrant information
Name
pegah Matoury
Name of organization / entity
Tarbat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 31 2524 5616
Email address
pegah.matoury@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
empty
Scientific title
"Effect of education via educational SMS(short message sending) on self care and quality of life in cancer patients"
Public title
"Effect of education via educational SMS(short message sending) on self care and quality of life in cancer patients under chemotherapy"
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-45 years Having a mobile phone with the ability to receive text message Having the ability to read . Individuals with gastrointestinal cancer without metastasis. Chemotherapy will be continue at least one month after the start of the study.
Exclusion criteria:
If the patient died during the intervention. Unable to continue participation in the study due to acute complications of cancer and its treatments. Increasing the severity of the disease in the patient.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were divided into two groups of interventions (A) and control(B) through block randomized allocation. Using a block size of four (12 blocks by using a computer program) for two groups (A and B) leads to six possible arrangements: AABB BBAA ABAB BABA ABBA BAAB.... and then these blocks are randomly sorted and individuals will be placed in two groups of intervention and control .
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who analyze the data of the study and patients do not know about the allocation in the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Arak University of Medical Sciences
Street address
Basij Square, Pardis complex
City
Arak
Province
Markazi
Postal code
8634173639
Approval date
2016-04-28, 1395/02/09
Ethics committee reference number
Ir.arakmu.rec.1394.269

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
C00-D48
ICD-10 code description
malignant neoplasm of GI tract

Primary outcomes

1

Description
self care
Timepoint
Two weeks and one month after starting the study
Method of measurement
self care questionnaire

2

Description
Quality of life
Timepoint
Two weeks and one month after starting the study
Method of measurement
Quality of life questionnaire for cancer patients

Secondary outcomes

empty

Intervention groups

1

Description
Participants in intervention group will complete all questionnaires, and in addition to receive routine care, will receive text messages about nutrition, increasing hope, decreasing anxiety, depression, fatigue and nausea, prevention of infection and bleeding, pevention and care of mucositis, and the importance of regular visits and follow up, for one month.
Category
Lifestyle

2

Description
Participants in control group will complete demographic, self care knowledge and behavior, and quality of life questionnaires and receive routine care
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Behbood Amiri
Street address
Daneshgah street
City
Arak
Province
Markazi
Postal code
0098 93 311602
Phone
+98 86 3417 3503
Fax
+98 86 3417 3505
Email
Behbodamiri@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Basij Square, Pardis Complex
City
َArak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Fax
+98 86 3417 3645
Email
arjomandzadegan@arakmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.18, Rahimi Ave, Ghandi street
City
Tehran
Province
Tehran
Postal code
5344151159
Phone
+98 914 323 7870
Email
zeinab_alizadeh88@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab Alizadeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.18, Rahimi Ave., Ghandi street
City
Tehran
Province
Tehran
Postal code
5344112159
Phone
+98 914 323 7870
Email
zeinab_alizadeh88@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zeinab َAlizadeh
Position
PhD student in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.18,Rahimi Ave,Ghandi street
City
Tehran
Province
Tehran
Postal code
5344132159
Phone
+98 935 651 2981
Email
zeinab_alizadeh88@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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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