The effect of education based on family-centered empowerment model versus no educational intervention on the self-care ability of patients with colorectal cancer
To determine the effect of education based on family-centered empowerment model on self-care ability of patients with colorectal cancer
Design
In this study, 72 eligible patients with colorectal cancer who refer to the Colorectal Clinic Surgery Department of Faghihi Hospital in Shiraz will be selected. The participants will be randomly allocated to experimental and control groups, and each will be assigned a code.
Settings and conduct
The study will be conducted in the colorectal cancer surgery department of Shahid Faghihi Hospital of Shiraz. The eligible patients will be randomly allocated to experimental and control groups. The experimental group members will receive 3 to 5 sessions of education based on family-centered empowerment model in groups of 5 through group discussions. During this time, members of the control group do not receive any special training. All participants will complete a researcher-made self-care ability assessment questionnaire before the intervention, immediately after the intervention, and one month after the end of the intervention.
Participants/Inclusion and exclusion criteria
Major inclusion criteria: A definite diagnosis of colorectal cancer according to the pathologic response of patients; age from 20 to 70 years; and the literacy to read and write. Major exclusion criteria: The impossibility for the presence of at least one member of the patient's family during training sessions and having difficulty with learning.
Intervention groups
Experimental group: They will receive 3 to 5 sessions of education based on family-centered empowerment model, which covers four stages: awareness and cognition, self-efficacy, self-esteem, and evaluation.
Control group: The control group will not receive this educational intervention.
Main outcome variables
self-care ability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180729040624N1
Registration date:2019-04-07, 1398/01/18
Registration timing:retrospective
Last update:2019-04-07, 1398/01/18
Update count:0
Registration date
2019-04-07, 1398/01/18
Registrant information
Name
Hojat alah Nasri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
h.nasri2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-05, 1397/04/14
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on family-centered empowerment model versus no educational intervention on the self-care ability of patients with colorectal cancer
Public title
The effect of family-centered empowerment model on self-care ability
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of colorectal cancer according to the pathological response of patients
Age from 20 to 70 years
Informed consent for participation
Literacy to read and write
History of surgery
Exclusion criteria:
Problems with learning
Impossibility of the presence of at least one member of the patient's family in the training sessions
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be allocated into experimental and control groups using the table of random numbers.
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
Birjand University of Medical Sciences
Street address
Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2018-07-04, 1397/04/13
Ethics committee reference number
IR.BUMS.REC.1397.090
Health conditions studied
1
Description of health condition studied
colorectal cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
Primary outcomes
1
Description
self-care ability
Timepoint
before the intervention, immediately after the intervention, and one month after the end of the intervention
Intervention group (family-centered empowerment model): The members will receive 3 to 5 sessions of education based on family-centered empowerment model, which covers four stages: awareness and cognition, self-efficacy, self-esteem, and evaluation. Education will be delivered in groups of 5 using group discussion.
Category
Behavior
2
Description
Control group: The control group will not receive a specific educational intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Hospital of Shiraz
Full name of responsible person
Hojat alah Nasri
Street address
Zand
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 1087
Email
faghihihsp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghafari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5056
Fax
Email
Drtooba.kazemi@gmail.com
Web page address
http://www.bums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hojatalah Nasri
Position
M.Sc. Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5632
Email
h.nasri2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hojatalah Nasri
Position
M.Sc. Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5632
Email
h.nasri2020@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hojatalah Nasri
Position
M.Sc. Student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Fax
+98 56 3243 0076
Email
h.nasri2020@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Deidentified Individual Participant Data Set
When the data will become available and for how long
After the article extracted from the research project is published and for six months
To whom data/document is available
Readers of the article
Under which criteria data/document could be used
For research purposes only
From where data/document is obtainable
Via email sent to the corresponding author of the extracted paper (Dr Gholamhosain Mahmudirad: midwifery@bums.ac.ir)
What processes are involved for a request to access data/document
Personal correspondence with the corresponding author of the article via email along with the provision of explanations concerning the research purposes and related evidence. A response will be made within a week.