Protocol summary

Study aim
Determining the relationship between teaching some stoic teachings and coping styles with stress among caregivers of patients with gastrointestinal cancers
Design
The clinical trial has a control group. The sample size is 80 people (40 people in each group). The randomization method is permutational blocking.
Settings and conduct
Stoic teachings were presented in eight sessions in the form of scenarios, Socratic questioning, group discussions, and electronic content (podcasts and educational videos) in cyberspace and in real space. Session zero was an introductory session, and session eight was a summary of the material from the previous sessions.Interventions will be held at Iranmehr Hospital.
Participants/Inclusion and exclusion criteria
Age 18-70 years, having the ability to read, write, and speak Persian, having a family relationship and the main role of caring for the patient, not having a specific disease or unstable medical condition that would prevent the patient from being able to care for a cancer patient, not having been diagnosed with cancer in the past four years, not having self-reported cognitive impairment, not having regular treatment by a psychologist or psychiatrist, informed consent, access to cyberspace, not having been hospitalized in a psychiatric ward with a diagnosis of mental disorders in the past two years, not having a history of suicide, not having received treatment with antipsychotic and anticonvulsant medications, not having abused or depended on substances in the past year, not having participated in previous or current educational programs in the field of psychology
Intervention groups
In the intervention group, some Stoic teachings are taught, and in the control group, no education is given.
Main outcome variables
Coping styles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241229064210N1
Registration date: 2025-01-17, 1403/10/28
Registration timing: retrospective

Last update: 2025-01-17, 1403/10/28
Update count: 0
Registration date
2025-01-17, 1403/10/28
Registrant information
Name
Amirhossein Boostani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3275 3138
Email address
amir.boostani198100@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2024-12-30, 1403/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training selected Stoic teachings on stress coping styles in family caregivers of patients with gastrointestinal cancers
Public title
The effect of training selected Stoic teachings on stress coping styles in family caregivers of patients with gastrointestinal cancers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the ability to read, write, and speak Persian, having a family relationship and the main role of caring for the patient, not having a specific disease or unstable medical condition that would prevent the patient from being able to care for a cancer patient, not having been diagnosed with cancer in the past four years, not having self-reported cognitive impairment, not having regular treatment by a psychologist or psychiatrist, informed consent, access to cyberspace, not having been hospitalized in a psychiatric ward with a diagnosis of mental disorders in the past two years, not having a history of suicide, not having received treatment with antipsychotic and anticonvulsant medications, not having abused or depended on substances in the past year, not having participated in previous or current educational programs in the field of psychology.
Exclusion criteria:
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation blocking
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of group which they are in it.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2024-09-07, 1403/06/17
Ethics committee reference number
IR.BUMS.REC.1403.164

Health conditions studied

1

Description of health condition studied
Coping styles
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Coping styles
Timepoint
60 days
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Education
Category
Other

2

Description
Control group: It has no intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranmehr hospital
Full name of responsible person
Amirhossein Boostani
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9717846785
Phone
+98 56 3162 6800
Email
amirhossein198100@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Masoud Yousefi
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
webda@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
Amirhossein Boostani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr street
City
Ferdows
Province
South Khorasan
Postal code
9773195793
Phone
+98 56 3275 3138
Email
amirhossein198100@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Amirhossein Boostani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr street
City
Ferdows
Province
South Khorasan
Postal code
9773195793
Phone
+98 56 3275 3138
Email
amirhossein198100@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Amirhossein Boostani
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
valiasr
City
Ferdows
Province
South Khorasan
Postal code
9773195793
Phone
+98 56 3275 3138
Email
amirhossein198100@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
Yes - There is a plan to make this available
Title and more details about the data/document
Information will be made available to other researchers and scholars upon reasonable request.
When the data will become available and for how long
Access period starts one month after results are published.
To whom data/document is available
Researchers
Under which criteria data/document could be used
The request must not conflict with the principle of confidentiality of individual information.
From where data/document is obtainable
Amirhossein Boostani amirhossein198100@gmail.com
What processes are involved for a request to access data/document
If the request is reasonable, within one week
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