Investigating end of life advance care planning with a microlearning method on the readiness and self-efficacy decision making in the family care givers of patient with advanced cancer
Determining the impact of advanced end-of-life care planning using the microlearning method on the readiness and self-efficacy of decision-making of family caregivers of patients with advanced cancer
Design
Randomized controlled clinical trial with control group, with parallel groups, single-blind, randomized, on 36 patients.
Settings and conduct
This is a randomized controlled trial. The study population includes all patients and family members of patients with advanced cancer who referred to Chamran Hospital in 2024.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients and family members of patients with advanced cancer who referred to Chamran Hospital for treatment in 2024.Exclusion criteria: Caregivers of advanced non-cancer patients
Intervention groups
Subjects will be selected using simple random sampling and randomly assigned to either the intervention or control group.The educational content will include type of medical care received, living will, treatment priorities, acceptance of death, surrogate decision-maker, and do-not-resuscitate order.
Main outcome variables
Decision-making self-efficacy and readiness of family caregivers in the experimental group will be measured using a tool for decision-making self-efficacy and readiness for advanced care planning both before and after the microlearning educational intervention. Additionally, decision-making and readiness of family caregivers in the control group will also be assessed using the same tools both before and after the implementation of the routine department program.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240703062324N1
Registration date:2024-10-03, 1403/07/12
Registration timing:prospective
Last update:2024-10-03, 1403/07/12
Update count:0
Registration date
2024-10-03, 1403/07/12
Registrant information
Name
Farideh Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2295 3153
Email address
ghorbanifaridehggoebani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating end of life advance care planning with a microlearning method on the readiness and self-efficacy decision making in the family care givers of patient with advanced cancer
Public title
Investigating advance care planning on the readiness and self-efficacy decision making of family caregivers in patient with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Caregivers of cancer patients who visit Shahid Chamran Hospital
Exclusion criteria:
The reluctance of caregivers to take part in the research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
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 Baqiyatallah University of Medical Sciences
Street address
Unit 2-4-4, Block 5, Ba'ath Township, near Shahid Chamran Hospital, Shahid Fakheri-zadeh St., Aghdasieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1693717138
Approval date
2024-08-10, 1403/05/20
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.089
Health conditions studied
1
Description of health condition studied
The educational content will include: type of medical care received, advance directive, acceptance of death, surrogate decision-maker, and Do-Not-Resuscitate (DNR) order.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Preparedness and self-efficacy of family caregivers for patients with advanced cancer"
Timepoint
Measurement points of preparedness and decision-making self-efficacy of caregivers before and after the intervention
Method of measurement
Questionnaire for preparedness and decision-making self-efficacy of caregivers"
Secondary outcomes
empty
Intervention groups
1
Description
The study group will be assessed before the educational intervention using the decision self-efficacy tool and the advanced care planning readiness tool. The intervention will then consist of microlearning video clips containing content on (type of medical care received, advance directives, acceptance of death, surrogate decision-maker, do not resuscitate order), as well as a lecture and Q&A session. Finally, participants will be reassessed using the decision self-efficacy tool and the advanced care planning readiness tool. The necessary data will be extracted from the results of the participants' questionnaires."
Category
Behavior
2
Description
Control group: The control group, without receiving any intervention, will also be assessed before and after the routine unit planning using the advanced care planning readiness and decision self-efficacy tools."
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Shahid Hospital
Full name of responsible person
Farideh Ghorbani
Street address
Unit 2-4-4, Block 5, Ba'ath Township, near Shahid Chamran Hospital, Shahid Fakheri-zadeh St., Aghdasieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1693717138
Phone
+98 21 2295 3153
Email
Ghorbanifaridehggoebani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Baqiyatallah University of Medical Sciences
Street address
Unit 2-4-4, Block 5, Ba'ath Township, near Shahid Chamran Hospital, Shahid Fakheri-zadeh St., Aghdasieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1693717138
Phone
+98 21 2295 3153
Email
Ghorbanifaridehggoebani@gmail.co
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Farideh Ghorbani
Position
Special care master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 2-4-4, Block 5, Ba'ath Township, near Shahid Chamran Hospital, Shahid Fakheri-zadeh St., Aghdasieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1693717138
Phone
+98 21 2295 3153
Email
Ghorbanifaridehggoebani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Farideh Ghorbani
Position
Senior student of special nursing care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 2-4-4, Block 5, Ba'ath Township, near Shahid Chamran Hospital, Shahid Fakheri-zadeh St., Aghdasieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1693717138
Phone
+98 21 2295 3153
Fax
Email
ghorbanifaridehggoebani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Farideh Ghorbani
Position
Senior student of special nursing care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 2-4-4, Block 5, Ba'ath Township, near Shahid Chamran Hospital, Shahid Fakheri-zadeh St., Aghdasieh, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1693717138
Phone
+98 21 2295 3153
Fax
Email
ghorbanifaridehggoebani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Education on advanced care planning for end-of-life care for caregivers of patients with advanced cancer includes topics such as medical care options, surrogate decision-making, advance directives, acceptance of death, and do-not-resuscitate orders.
When the data will become available and for how long
The access period will commence six months after the publication of the results."
To whom data/document is available
"This resource will be available to researchers affiliated with academic institutions and hospitals, as well as individuals engaged in relevant fields."
Under which criteria data/document could be used
"There are no particular conditions in mind at present."
From where data/document is obtainable
"Please refer to the Baqiyatallah University of Medical Sciences website or contact the project manager via email."
What processes are involved for a request to access data/document