History
# Registration date Revision Id
2 2026-02-15, 1404/11/26 373143
1 2025-11-14, 1404/08/23 362735
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
The effect of self-care and health literacy training program on the quality of life of patients with breast cancer in Hamedan city.
Design
A quasi-experimental study that will be conducted as an intervention, pre-test-post-test with a control group. In the first part, 86 patients with breast cancer who refer to the Cancer Center of Besat Hospital, Hamadan in 1404 will be selected as a sample. Given the quasi-experimental method of the study, patients will be selected using the convenience sampling method based on the inclusion criteria.
Settings and conduct
The experimental group will be exposed to a self-care and health literacy program and content on the WhatsApp social network for two months (16 sessions of several hours). The control group will not receive any training.
Participants/Inclusion and exclusion criteria
Breast cancer diagnosis (patients who have been diagnosed with breast cancer and are in various stages of treatment) Ability to understand the concepts of self-care education Non-participation in other similar interventions
Intervention groups
First, in order to find out the level of quality of life and health literacy of patients in the initial sample, it will be measured based on standard questionnaires on quality of life and health literacy of Iranian women with breast cancer. Then, the effect of self-care and health literacy education through WhatsApp social networks will be carried out in two experimental and control groups (each group with a volume of 43 people). The experimental group will be placed under the self-care and health literacy educational program and content on the WhatsApp social network platform for two months (16 sessions of several hours). The control group will not receive education.
Main outcome variables
Improving health literacy improves the quality of life of breast cancer patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251016067650N1
Registration date: 2025-11-14, 1404/08/23
Registration timing: registered_while_recruiting

Last update: 2025-11-14, 1404/08/23
Update count: 1
Registration date
2025-11-14, 1404/08/23
Registrant information
Name
Abed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3312 6381
Email address
hoseini.abed@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-22, 1404/06/31
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of a Self-Care Education Program Based on Social Network and Health Literacy on the Quality of Life of Breast Cancer Patients in Hamadan
Public title
The effect of self-care education program on the quality of life of patients with breast cancer.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Breast cancer diagnosis (patients who have been diagnosed with breast cancer and are in various stages of treatment) Consent to participate in the study Age: Usually patients aged 18 years and above Ability to understand the concepts of self-care education Non-participation in other similar interventions
Exclusion criteria:
Inability to continue the study (patients who are unable to continue the study for any reason (medical problems, change in health status) Patient withdrawal Non-compliance with study protocols Death or disease exacerbation Participation in other concurrent interventions
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of hamedan University of Medical Sciences
Street address
Shahid Fahmideh Blvd., Medan, University Headquarters, 4th Floor, Vice Chancellor for Research and Technology
City
hamedan
Province
Hamadan
Postal code
6517838784
Approval date
2025-09-30, 1404/07/08
Ethics committee reference number
IR.UMSHA.REC.1404.558

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
Quality of life score in the QLQ-C30 quality of life questionnaire and the QLQ-BR32 breast cancer-specific quality of life questionnaire
Timepoint
2 months
Method of measurement
QLQ-C30 quality of life questionnaire and the QLQ-BR32 breast cancer-specific quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention in this study will be based on the Orem Self-Care Education Program and will be designed via WhatsApp messenger. In this program, breast cancer patients will receive continuous, individual or group education in a safe and accessible digital environment, such as: familiarizing patients with the nature of breast cancer, diagnosis, symptoms, treatment, side effects of treatment, especially chemotherapy, skin and hair care, oral hygiene, and ....
Category
Lifestyle

2

Description
Control group: Does not receive training
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Cancer Center
Full name of responsible person
Abdulazim Siddiqui Pashaki
Street address
Hamedan - Shahid Beheshti Blvd - Besat Specialized and Subspecialty Hospital - Comprehensive Cancer Center
City
hamedan
Province
Hamadan
Postal code
6517838784
Phone
+98 81 3838 0548
Email
cancer@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Hamadan, Shahid Fahmideh Blvd., University Headquarters, Fourth Floor, Vice Chancellor for Research and Technology
City
hamedan
Province
Hamadan
Postal code
6517838784
Phone
+98 81 3131 4058
Email
Fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abedin Hosseini Ahangari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Library and Medical Information
Street address
North Saidiyeh, Niko 2 Alley, No. 202, 2nd Floor
City
hamedan
Province
Hamadan
Postal code
6517838741
Phone
+98 81 3262 3422
Email
hoseini.abed@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abedin Hosseini Ahangari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Library and Medical Information
Street address
North Saidiyeh, Niko 2 Alley, No. 202, 2nd Floor
City
hamedan
Province
Hamadan
Postal code
6517838741
Phone
+98 81 3262 3422
Email
hoseini.abed@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abedin Hosseini Ahangari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Library and Medical Information
Street address
North Saidiyeh, Niko 2 Alley, No. 202, 2nd Floor
City
hamedan
Province
Hamadan
Postal code
6517838741
Phone
+98 81 3262 3422
Email
hoseini.abed@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No further information available.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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