Investigation of the effectiveness of stress-immunization group training program on existential anxiety and resiliency of cancer patients
Design
This study is a nonblinded clinical trial. The research population will be included all patients with cancer who will refer to Imam Reza hospital in Kermanshah city. 30 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at Imam Reza Hospital in Kermanshah, is not blinded one. Before the study, immediately and one month after the end of the study, anxiety and resiliency questionnaire will be provided to the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of cancer; lack of mental illness and use of psychotropic drugs; Absence of thyroid gland diseases
Exclusion criteria: Physical disability due to the progression of illness and death; Absence more than two sessions in training sessions
Intervention groups
The intervention group will receive 90-minute training on immunization against stress (Maicon Baum model) each week 2 sessions, during eight sessions.
The control group will receive the ward usual care.
Main outcome variables
Existential anxiety, Resiliency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N100
Registration date:2018-08-29, 1397/06/07
Registration timing:registered_while_recruiting
Last update:2018-08-29, 1397/06/07
Update count:0
Registration date
2018-08-29, 1397/06/07
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Stress Inoculation Training on Existential Anxiety and Resilience of cancer patients
Public title
The Effect of Stress Inoculation Training on Existential Anxiety and Resilience of cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of cancer
The ability to understand and speak
Exclusion criteria:
Mental illness and the use of psychoactive drugs
Patients with thyroid gland diseases
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
ir.kums.rec.1397.165
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C80.0
ICD-10 code description
Disseminated malignant neoplasm, unspecified
Primary outcomes
1
Description
Existential anxiety
Timepoint
Before the study, immediately and one month after the end of the study
Method of measurement
Based on existential anxiety questionnaire
2
Description
Resiliency
Timepoint
Before the study, immediately and one month after the end of the study
Method of measurement
Base on Connor and Davidson Resiliency Questionnaire(CD-RIS)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 90-minute training on immunization against stress (Maicon Baum model) each week 2 sessions, during eight sessions.
Category
Other
2
Description
The control group will receive the ward usual care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Sara Ahmadi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
sa.Ah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Amadi
Position
Master of Internal and Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sa.Ah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Jahangir Rezaie
Position
Master of Internal and Surgical Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Jahangir.rezaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sara Ahmadi
Position
Master of Internal and Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
sa.Ah@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
Undecided - It is not yet known if there will be 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
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail