Comparison of the efficacy of follow-up via mobile phone and SMS on adherence to treatment and quality of life in breast cancer patients undergoing radiation therapy
(1)Objective: to compare the effect of cell phone follow up and follow through SMS on quality of life and treatment adherence in patients with breast cancer and undergoing radiation
(2) Design: randomized controlled trial
(3) Setting and conduct: Eligible patients will selected by convenience sampling and randomly will assigned into two intervention groups (cell phone and SMS) and control group.
(4) Participants including major eligibility criteria: the samples consist of 96 people. Inclusion criteria include willingness to participate in research, owning a cell phone, Literate, Lack of vision and hearing problems and lack of speech disorders. Exclusion criteria include Failure to respond to calls and text messages, Unwillingness to continuing to participate in the study, Rehospitalization, Psychological and physical problems resulting in disability at any stage of the investigation
(5) Intervention: At first the Quality of life and treatment adherence questionnaires will be completed by all three groups. The control group only will receive routine hospital follow-ups. Telephone follow-up group, will receive the instructions through calls by the researcher three times a week for eight weeks. Group tracking via text message, will receive the instructions through an SMS sending daily by the researcher for eight weeks. After eight weeks the questionnaires will complete by all three groups
(6) Main outcome measures: Quality of life and treatment adherence
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506294736N9
Registration date:2016-07-20, 1395/04/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-20, 1395/04/30
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of follow-up via mobile phone and SMS on adherence to treatment and quality of life in breast cancer patients undergoing radiation therapy
Public title
Comparison of the efficacy of follow-up via cell phone and SMS on adherence to treatment and quality of life in breast cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in research, owning a cell phone, Literate, Lack of vision and hearing problems and lack of speech disorders.
Exclusion criteria: Failure to respond to calls and text messages, Unwillingness to continuing to participate in the study, Rehospitalization, Psychological and physical problems resulting in disability at any stage of the investigation
Age
From 15 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
Postal code
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
KUMS.REC.1395.175
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
Quality of life
Timepoint
At the start of the study and after eight weeks
Method of measurement
Quality of Life Questionnaire
Secondary outcomes
1
Description
Adherence to treatment
Timepoint
At the start of the study and after eight weeks
Method of measurement
Adherence to treatment questionnaire
Intervention groups
1
Description
In cell phone group, the researcher Via phone call delivers the instructions on preventing and managing complications associated with radiation therapy three times a week for eight weeks.
Category
Lifestyle
2
Description
Group tracking via text message, will receive the instructions on preventing and managing complications associated with radiation therapy through SMS sending daily by the researcher for eight weeks.
Category
Lifestyle
3
Description
The control group only will receive routine hospital follow-ups.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital of Kermanshah
Full name of responsible person
Alireza Khatony
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Street, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Behrooz Hamzeh
Street address
Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences, Vice chancellor for research
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
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza khatony
Position
PhD, Faculty Member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83382794960
Fax
Email
akhatony@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9496
Fax
Email
Akhatony@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education, Faculty member
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9496
Fax
Email
akhatony@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)