Helping to increase the self-efficacy of breast cancer patients by continuing the educational program according to the importance of the topic.
Design
This research will be a randomized clinical trial. The research sample is women from the research community who meet the entry criteria. The initial sampling was done by the available method and the total sample size was determined to be 80 people, of which 40 people will be in the intervention group and 40 people will be in the control group.
Settings and conduct
This research will be conducted in Imam Khomeini Hospital Institute Cancer Center and the participants will be assigned to two intervention and control groups according to the entry criteria by random block method using the Randomizer.org site. In the first session, the intervention group receives the videocassettes and then for three weeks, they receive SMS reminders and calls for advice. But the control group only receives the programs of the clinic.
Participants/Inclusion and exclusion criteria
suffering from breast cancer in one of the stages 2, 3, 4, undergoing at least 3 stages of chemotherapy, women aged 20 to 60 years.
Intervention groups
In the first session, which is held face-to-face, the intervention group receives educational videos with specific topics and determines which one to watch each week, and then a weekly reminder SMS and then a call to answer questions.
Main outcome variables
The continuation of the care program after the patient's discharge may affect the self-efficacy of breast cancer patients and after that it can be suggested as a program to improve the health of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230629058617N1
Registration date:2023-09-26, 1402/07/04
Registration timing:prospective
Last update:2023-09-26, 1402/07/04
Update count:0
Registration date
2023-09-26, 1402/07/04
Registrant information
Name
Mina Moafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6683 5700
Email address
mina.moafi.nurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuing care program on self_efficacy of women with breast cancer.
Public title
The effect of continuing care program on self_efficacy of women with breast cancer.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of breast cancer diagnosis by an oncologist and diagnostic tests in the last 6 months.
Having breast cancer in one of the stages 2, 3, 4
Ability to speak Persian
Willingness to participate in the study
Passing at least three stages of chemotherapy
The age of women is between 20-60 years
Full awareness and alertness and sign the consent form knowingly
Exclusion criteria:
Unwillingness to continue participating in research
Hospitalization during the intervention period
The occurrence of events unrelated to the disease during the study
Attending other educational and counseling programs during the intervention
Suffering from other chronic diseases
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Then they will be assigned to two intervention and control groups by random block method using Randomizer.org.Concealment of the created sequence will be done using sealed dark envelopes. For this purpose, 20 groups are divided into four groups, A is the intervention group and B is the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, for the intervention group, training is done through educational videocasts with the main problems of the patients, then reminders through SMS and finally counseling through phone calls.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital.
Street address
Vali Asr Square - the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex.
City
Tehran
Province
Tehran
Postal code
3314114197
Approval date
2023-08-10, 1402/05/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.182
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
Z85.8
ICD-10 code description
Personal history of malignant neoplasms of other organs and systems
Primary outcomes
1
Description
Continuity of care plan
Timepoint
The effect of the continuation of the care program on the self-efficacy of women with breast cancer is measured on the first day and then 4 weeks after the intervention.
Method of measurement
Specific breast cancer self-efficacy questionnaire
Secondary outcomes
1
Description
self_efficacy
Timepoint
The effect of the continuation of the care program on the self-efficacy of women with breast cancer is measured on the first day and then 4 weeks after the intervention.
Method of measurement
Specific breast cancer self-efficacy questionnaire
Intervention groups
1
Description
Intervention group: they will receive educational videos in the face-to-face meeting and watch them at the appointed time for three weeks, and counseling will be done through weekly SMS reminders and phone calls.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
imam khomeini hospital
Full name of responsible person
Mina moafi
Street address
Rodaki ave, khamse ave, 22 bahman street, 1
City
Tehran
Province
Tehran
Postal code
1346645413
Phone
+98 21 6683 5700
Email
mina.moafi.nurse@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
doctor sarie portaghi
Street address
Faculty of Nursing and Midwifery, Tawheed Square, Dr. Mirkhani Street, (Nusrat East), Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4124
Email
Higher_education@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
doctor sarie portaghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Tawheed Square, Dr. Mirkhani Street, (Nusrat East), Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
61054124
Email
spoortaghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sarieh portaghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tawheed Square, Dr. Mirkhani St., (East Nusrat), Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 4411
Email
s-poortaghi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mina moafi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 1, Rudaki St., Khamse Street, 22 Bahman St
City
Tehran
Province
Tehran
Postal code
۱۳۴۶۶۴۵۴۱۳
Phone
+98 21 6683 5700
Email
mina.moafi.nurse@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Relationship between continuity of care program and self-efficacy
When the data will become available and for how long
Almost 6 months after the end of the intervention
To whom data/document is available
All researchers of Tehran University
Under which criteria data/document could be used
Researches that examine the relationship between self-efficacy and continuity of care program in chronic diseases.
From where data/document is obtainable
Researchers can communicate with the administrator: Mina moafi, through email.
email: mina.moafi.nurse@gmail.com
What processes are involved for a request to access data/document
The applicant receives the required information less than a month after sending the application via email.