Effect of implementation of self-management five-A model versus no implementation on quality of life patients with breast cancer: a randomized clinical trial
Objectives: To assess the effect of implementation of self-management five-A model versus no implementation on quality of life patients with breast cancer
Design: A randomized clinical trial.
Setting and conduct: The eligible patients with breast cancer who will refer to Tohid Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 35 to 65 years; breast cancer; under chemotherapy with a history of mastectomy.
Exclusion criteria: Mental disease; participating in similar study; deterioration of the patient's situation during study period.
Intervention group: Routine treatment plus implementation of self-management five-A model in five stage and two educational session 1.5 hours with a week interval.
Control group: Just routine treatment.
Primary outcome: Assessing the quality of life before intervention and 3 months after intervention using QLQ-C30 and QLQ-BR23 questionnaires.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710159014N196
Registration date:2017-10-18, 1396/07/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-18, 1396/07/26
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Kurdistan University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of implementation of self-management five-A model versus no implementation on quality of life patients with breast cancer: a randomized clinical trial
Public title
Effect of implementation of self-management five-A model versus no implementation on quality of life patients with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 35 to 65 years; breast cancer; under chemotherapy with a history of mastectomy.
Exclusion criteria: Mental disease; participating in similar study; deterioration of the patient's situation during study period.
Age
From 35 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Kurdistan University of Medical Sciences, Pasdaran Ave
City
Sanadaj
Postal code
Approval date
2017-09-09, 1396/06/18
Ethics committee reference number
IR.MUK.REC.1396/193
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
Assessing the quality of life
Timepoint
Before intervention and 3 months after intervention
Method of measurement
Using QLQ-C30 and QLQ-BR23 questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus implementation of self-management five-A model in five stage and two educational session 1.5 hours with a week interval.
Category
Other
2
Description
Control group: Just routine treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Mayar Karhor
Street address
Tohid Hospital, Gariashan Ave.
City
Sanadaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Kurdistan University of Medical Sciences
Full name of responsible person
Dr Farzin Rezaei
Street address
Kurdistan University of Medical Sciences, Pasdaran Ave
City
Sanadaj
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 and Technology, Kurdistan 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
Tohid Hospital
Full name of responsible person
Mayar Karhor
Position
Master of Nursing
Other areas of specialty/work
Street address
Tohid Hospital, Gariashan Ave.
City
Sanadaj
Postal code
Phone
+98 87 3328 6112
Fax
Email
ma.kalhor@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tohid Hospital
Full name of responsible person
Mayar Karhor
Position
Master of Nursing
Other areas of specialty/work
Street address
Tohid Hospital, Gariashan Ave.
City
Sanadaj
Postal code
Phone
+98 87 3328 6112
Fax
Email
ma.kalhor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)