Investigating the effect of implementing the family-centered empowerment model on resilience and hope in breast cancer patients referred to diagnostic and treatment centers
Determining the effect of implementing the family-centered empowerment model of resilience and hope in breast cancer patients
Design
The study will include an intervention group and a control group, each consisting of 44 participants. A total of 88 participants will be recruited from diagnostic and treatment centers in Ilam based on the inclusion criteria. Participants will be randomly assigned to either the intervention or control group using a block randomization procedure with a block size of 2.
Settings and conduct
The study will be conducted at diagnostic and treatment centers in Ilam. The study will involve an 8-session educational program for both the patient and their caregiver. During this time, the control group will not receive any intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Confirmed diagnosis of cancer by a medical specialist. Age between 18 and 65 years. At least 6 months have passed since the diagnosis of breast cancer.
Fully alert and oriented. Ability to read and write. No underlying medical conditions. No major stressful life events, such as the death of a loved one, within the past 6 months. Completion of the informed consent form.
Exclusion criteria for patients
•Patient's unwillingness to continue •Crisis during the study •Incomplete questionnaires •Missing more than one session of the educational program
Intervention groups
The family-centered empowerment model will be implemented in four main stages over eight sessions for the intervention group: 1) Threat perception, 2) Enhancement of self-efficacy/problem-solving, 3) Enhancement of self-belief and self-esteem through educational participation, and 4) Evaluation. The control group, after obtaining informed consent, will receive standard care
Main outcome variables
resilience - hope
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250105064279N1
Registration date:2025-04-02, 1404/01/13
Registration timing:prospective
Last update:2025-04-02, 1404/01/13
Update count:0
Registration date
2025-04-02, 1404/01/13
Registrant information
Name
Masoumeh Zeraati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3225 1543
Email address
masoomehzeraati97mz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-05, 1404/01/16
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of implementing the family-centered empowerment model on resilience and hope in breast cancer patients referred to diagnostic and treatment centers
Public title
Investigating the effect of implementing the family-centered empowerment model on resilience and hope in breast cancer patients referred to diagnostic and treatment centers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of cancer by a specialist doctor
Based on clinical findings, cytological studies, and medical diagnosis, the breast cancer is staged at 1-3.
Age between 18 and 65 years
At least 6 months have passed since the breast cancer diagnosis-
Fully conscious and alert
Able to read and write at a basic level
No visual or auditory impairments that significantly affect communication
No history of underlying medical conditions (such as heart attack, stroke, heart failure, acute psychiatric illness, or known psychiatric disorder)
No significant stressful life events, such as the death of a loved one, within the past 6 months(based on patient reports)
Completion of an informed consent form to participate in the study
Living with at least one family member
Not employed as a healthcare provider
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, 88 breast cancer patients were selected from diagnostic and treatment centers in Ilam, based on the study's inclusion criteria. Subsequently, they were randomly assigned to two groups (intervention and control) using a block randomization method with a block size of 2
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 Ilam University of Medical Sciences
Street address
Banganjab, Ilam University of Medical Sciences, Research and Technology Building
City
ilam
Province
Ilam
Postal code
6939177143
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.MEDILAM.REC.1403.247
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site
Primary outcomes
1
Description
resilience
Timepoint
before the intervention - after the intervention and one month after the intervention
Method of measurement
Connor-Davidson Resilience Scale
2
Description
hope
Timepoint
before the intervention - after the intervention and one month after the intervention
Method of measurement
Miller Hope Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : The stages of the family-centered empowerment model are in 4 main steps, respectively, including 1- understanding the threat, 2- promoting self-efficacy/problem solving, 3- promoting self-confidence and self-esteem through educational participation, 4- evaluation will be done during 8 sessions for the intervention group. became .
Category
Other
2
Description
Control group: Patients in the control group will not be subjected to any intervention in the form of research
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital, Ilam
Full name of responsible person
Masoumeh Zeraati
Street address
Banganjab, the end of the research boulevard
City
ilam
Province
Ilam
Postal code
٦٩٣١٩٣٤٨٣٣
Phone
+98 84 3224 8555
Email
razihos@medilam.ac.ir
Web page address
http://razi.medilam.ac.ir/en-us/
2
Recruitment center
Name of recruitment center
Oncology offices in the city of Ilam
Full name of responsible person
Masoumeh Zeraati
Street address
Ilm University of Medical Sciences Research Boulevard Bangunjab District
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
masoomehzeraati97mz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Masoumeh Zeraati
Street address
Banganjab, Ilam University of Medical Sciences
City
ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
masoomehzeraati97mz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Non-communicable diseases research center
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
Ilam University of Medical Sciences
Full name of responsible person
Masoumeh Zeraati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ilam University of Medical Sciences Pajuhesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
masoomehzeraati97mz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Masoumeh Zeraati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ilam University of Medical Sciences Pajuhesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
masoomehzeraati97mz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Masoumeh Zeraati
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ilam University of Medical Sciences Pajuhesh Boulevard
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
masoomehzeraati97mz@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
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
Yes - There is 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
All potentially identifiable data can be shared after individuals have been anonymized
When the data will become available and for how long
Access to the data will begin six months after the results are published
To whom data/document is available
For all researchers
Under which criteria data/document could be used
For use in other research
From where data/document is obtainable
A.raiesifar@gmail.com
You can refer to this email address :masoomehzeraati97mz@gmail.com
What processes are involved for a request to access data/document
After the completion of the study and the publication of the results, by sending an email to the responsible author, the documentation can be accessed within a maximum of 6 weeks