Development, Validation and Evaluation of the Effectiveness of the native Spiritual Care Protocol Based on Iranian-Islamic Culture to increase spiritual health of Advance Cancer Patients and Their Caregivers Suitable for Covid-19 pandemic conditions
Implementing and evaluating the effectiveness of the spiritual care model to increase the spiritual health of patients with advanced cancer and their caregivers
Design
The sample group will be available based on sampling and will include 5 patients and 5 caregivers.
Settings and conduct
Patients with advanced cancer and their caregivers referred to the MACSA Cancer Control Center will receive individual spiritual care intervention.
Participants/Inclusion and exclusion criteria
Belief in God
- Belief in the resurrection
- Age range of 40 to 60 years in patients
- Caregiver membership as a first-class member of the patient's family (spouse, parent, child, sibling).
- The caregiver should be recognized as the main person caring for the patient who has the main duty.
- History of not having psychotic psychiatric disorders in caregivers and patients.
Criteria for excluding people from the research are as follows:
Existence of brain metastasis or any other type of disease or treatment complication that has led to brain damage or lack of speech in the patient.
- Neurological-cognitive diseases that affect the correctness of the answers
Intervention groups
In the intervention group, the spiritual care protocol will be implemented for 5 patients with advanced cancer and their caregivers.
Main outcome variables
spiritual health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220509054792N1
Registration date:2022-11-14, 1401/08/23
Registration timing:registered_while_recruiting
Last update:2022-11-14, 1401/08/23
Update count:0
Registration date
2022-11-14, 1401/08/23
Registrant information
Name
Nooramad Latifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 4957
Email address
dr.noorahmadlatifi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development, Validation and Evaluation of the Effectiveness of the native Spiritual Care Protocol Based on Iranian-Islamic Culture to increase spiritual health of Advance Cancer Patients and Their Caregivers Suitable for Covid-19 pandemic conditions
Public title
Development, Validation and Evaluation of the Effectiveness of the native Spiritual Care Protocol Based on Iranian-Islamic Culture in Advance Cancer Patients and Their Caregivers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Belief in God
Belief in the resurrection
Age range of 40 to 60 years in patients
Caregiver membership as a first-degree member of the patient's family (spouse, parent, child, sibling).
The caregiver should be recognized as the main person caring for the patient who has the main duty
History of non-occurrence of psychiatric disorders in caregivers and patients.
Exclusion criteria:
Presence of brain metastasis or any other disease or therapeutic complication that has resulted in brain injury or non-speech in the patient
Having neurocognitive diseases that affect the correctness of the responses.
Age
From 40 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Tehran Hemat Highway next to Milad Tower، 14535
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2022-03-12, 1400/12/21
Ethics committee reference number
IR.IUMS.REC.1400.1210
Health conditions studied
1
Description of health condition studied
advance cancer
ICD-10 code
C80
ICD-10 code description
Malignant neoplasm without specification of site
Primary outcomes
1
Description
spiritual health
Timepoint
Before the intervention and after the end of the intervention
Method of measurement
politson & ellison spiritual health questionnaire (1982)
Secondary outcomes
empty
Intervention groups
1
Description
There is an intervention in cancer patients and their caregivers which is done first and last and will be examined as the third phase. The details of the intervention's content will be the outcome of the results of phases 1 & 2 of this research. Consequently, the details will be determined after the fulfillment of the previous phases. The intervention's content is spiritual care which will be done in 8 to 12 sessions. Meetings will be held individually. The content of the intervention focused on the relationship with self, others, nature, and God.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MACSA
Full name of responsible person
Neda Shahvaroughi Farahani
Street address
MACSA Clinic, Hazrat Fatemeh Hospital, 21st Street, Yousefabad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۶۶۶۷۴۵۱
Phone
+98 21 8872 0035
Email
info@macsa.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Keyvani
Street address
Iran University Campus, Hemmat freeway, next to Milad tower, Tehran,
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
latifi.na@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Noor Ahmad Latifi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Plastic & Reconstructive Surgery
Street address
Hazrat Fatemeh Hospital, 21st Street, Yousefabad, Tehran
City
Tehran
Province
Tehran
Postal code
14339 33111
Phone
+98 21 8871 7272
Email
latifi.na@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
MACSA
Full name of responsible person
Seyede Hasti Tamaddon
Position
Psychologist،spiritual caregiver
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
MACSA Clinic, Hazrat Fatemeh Hospital, 21st Street, Yousefabad, Tehran
City
Tehran
Province
Tehran
Postal code
14339 33111
Phone
+98 21 8872 0035
Email
hasti.tamaddon@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Noor Ahmad Latifi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Plastic & Reconstructive Surgery
Street address
Hazrat Fatemeh Hospital, 21st Street, Yousefabad, Tehran
City
Tehran
Province
Tehran
Postal code
14339 33111
Phone
+98 21 8871 7272
Email
latifi.na@iums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study will be presented in the form of a final report to the relevant organization.
When the data will become available and for how long
After the publication of the article extracted from the study
To whom data/document is available
After the publication of the article, the study is open to the public
Under which criteria data/document could be used
by email of corresponding author
From where data/document is obtainable
by email of corresponding author
What processes are involved for a request to access data/document
After receiving the request via email, the data will be provided to the applicants while maintaining the confidentiality.