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
-
A slight change of two prepositions in the title
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20251016067650N1
Registration date:
2025-11-14, 1404/08/23
Registration timing:
registered_while_recruiting
Last update:
2026-02-18, 1404/11/29
Update count:
1
-
Registration date
-
2025-11-14, 1404/08/23
-
Registrant information
-
-
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 orem Self-Care Education Program delivered through a social media platform on quality of life and health literacy among patients with breast cancer 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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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