Investigating the Effect of using supportive care based on FICA assessment on the Hope and Spiritual health of young adults with cancer (human intervention study before and after trial)
Determining the impact of using FICA-based supportive care on Spiritual health and Hope in young adults with cancer
Design
Human interventional study (before and after trial), on 90 patients, with random block allocation with replacement
Settings and conduct
After obtaining informed consent, Paloutzian and Omid Snyder spiritual health questionnaire will be completed by the patient or the researcher one week before the intervention. First, the spiritual evaluation of patients during the interview will be done based on the FICA evaluation method in four areas of spiritual evaluation, which include: the existence of faith or belief, the importance of spirituality in a person's life, the person's spiritual community, and interventions to meet spiritual needs. Spiritual needs will be determined and based on that, supportive interventions based on the nursing process will be carried out individually in the oncology department of Shahid Jalil Yasouj Hospital.
Participants/Inclusion and exclusion criteria
Entry criteria: 1) final diagnosis of cancer 2) age range of 20 to 55 years 3) patient's awareness of his diagnosis 4) spiritual health score 20 to 40 and hope 12 to 24 5) informed consent for participation
Criteria for non-entry: 1) patient's unwillingness to continue participating in the study 2) age range below 20 years and above 55 years 3) lack of awareness of his disease diagnosis
Intervention groups
In the intervention group, the spiritual evaluation of the patients will be done during the interview, based on the FICA evaluation method. Then the spiritual needs will be determined and based on that support interventions will be done individually based on the nursing process. People in the control group will receive their usual care.
Main outcome variables
Hope and spiritual health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240707062355N1
Registration date:2024-08-05, 1403/05/15
Registration timing:prospective
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
maryam moayedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3840 3424
Email address
moayedimaryam290@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-17, 1403/05/27
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of using supportive care based on FICA assessment on the Hope and Spiritual health of young adults with cancer (human intervention study before and after trial)
Public title
The effect of using supportive care based on FICA assessment on Hope and Spiritual health of young adults with cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Final diagnosis of cancer
Age range from 20 to 55 years
A score of 20 to 40 for spiritual health and hope is 12 to 24, which indicates low spiritual health and hope.
Exclusion criteria:
The patient's unwillingness to continue participating in the study
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method was used, considering the presence of 2 control and intervention groups, blocks of size 2 were considered, and two combinations of AB and BA were considered as all possible modes of allocation of patients in each block. are defined The randomization unit is each person who will be independently and randomly assigned to one of the two intervention or control groups. A lottery tool will be used for randomization. First, the labeling of the groups was determined using a lottery that A = intervention and B = control. The way to make a random sequence is that according to the total number of 90 patients, using a lottery with repositioning, 45 random sequences of AB and BA combinations will be generated, meaning that for each block, one of the two AB combinations Or BA will be randomly selected and this process will be repeated 45 times to determine the allocation order for all 90 patients.The way people enter the randomly generated chain will be in such a way that after selecting the patients using the available method and confirming eligibility based on the entry and non-entry criteria, each patient will be assigned to the control or intervention group based on the selected combination. will be. After allocating two patients in order and based on the composition of the current block, go to the next block and this work will continue until the allocation of 90 patients. Anonymization will be done only for the data analyst and the data will be presented to him in coded form.
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 Yasouj University of Medical Sciences
Street address
Shahid Motahhari Blvd., Headquarters of Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-06-10, 1403/03/21
Ethics committee reference number
IR.YUMS.REC.1403.040
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
(C00-C97)
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
Hope
Timepoint
Measurement of hope scale before the start of the study and after the end of the individual intervention
Method of measurement
Snyder's Life Expectancy Questionnaire
2
Description
Spiritual well being
Timepoint
Measurement of spiritual health scale before the start of the study and after the end of the individual intervention
Method of measurement
Palutzian and Ellison Spiritual Health Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, the spiritual evaluation of the patients will be done during the interview, based on the FICA evaluation method. Based on the information collected from the FICA needs assessment, the patient's spiritual needs will be determined and based on that, supportive interventions will be carried out individually based on the nursing process.
Category
N/A
2
Description
People in the control group will receive their usual care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology Department of Shahid Jalil Hospital
Full name of responsible person
Dr. Iraj Ayazzadeh
Street address
Shahid Qorani Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 917 742 4674
Fax
+98 74 3333 7001
Email
Iraja4674@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amin Hosseini
Street address
Shahid Motahari Blvd. - Headquarters of Yasuj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
07433337230
Phone
+98 74 3333 7230
Fax
+98 74 3333 7230
Email
aminhomo@yahoo.com
Web page address
https://www.yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data related to the study's main outcomes will be published.
When the data will become available and for how long
The access period starts after the results are printed.
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to conduct research on qualified people, as well as for the transparency of the study process, statistical analysis is also allowed.
From where data/document is obtainable
To receive documents, send a message to email
moayedimaryam@gmail.com
What processes are involved for a request to access data/document
Access to the documents is after obtaining permission from the Research Vice-Chancellor of Yasouj University of Medical Sciences and with the coordination of the main researcher of the research.