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Comparison of the effectiveness of the educational package "Awareness of the treatment process" for breast cancer patients on reducing anxiety and increasing information individual and online group

Protocol summary

Study aim
Studying the effectiveness of the educational package "Awareness of the treatment process" for breast cancer patients in person and online on anxiety and awareness of the disease in newly diagnosed cancer patients.
Design
A clinical trial with two intervention groups, with parallel groups, double-blind, randomized, on 60 patients, in order to randomly assign patients to each group, the Block balance method will be used
Settings and conduct
The educational package "Awareness of the treatment process" for cancer patients is a combination of video and face-to-face training, and in an interdisciplinary way, it teaches the basic and essential care needs of patients at the beginning of treatment by specialists and professors of different fields, for patients with cancer. For cancer patients who are at the beginning of treatment processes, it is developed and implemented in the palliative medicine clinic of Seyed Al-Shahada Hospital with the presence of a nurse. Each session will be about an hour long educational video and after that the nurse will answer the patients' questions. In the online section of the site, patients will be provided with this educational package "Information about the treatment process" only in the form of educational videos.
Participants/Inclusion and exclusion criteria
Patients with new breast cancer admitted to Seyed al-Shohada Hospital in Isfahan, aged between 30 and 65 years old, referred by an oncologist, not suffering from a serious psychiatric illness, not abusing drugs or being addicted to them
Intervention groups
In the first group, the educational package "Awareness of the treatment process" for cancer patients will be presented in person, and the relevant follow-ups will be done. In the second group, people will receive the educational package "Awareness of the treatment process" for cancer patients online.
Main outcome variables
INFO-25 HADS STAI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230119057155N3
Registration date: 2024-06-06, 1403/03/17
Registration timing: prospective

Last update: 2024-06-06, 1403/03/17
Update count: 0
Registration date
2024-06-06, 1403/03/17
Registrant information
Name
seyedeh hanieh salimi arshad moghaddam pishkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4432 9865
Email address
haniyehsalimi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of the educational package "Awareness of the treatment process" for breast cancer patients on reducing anxiety and increasing information individual and online group
Public title
Comparison of the effectiveness of the educational package "Awareness of the treatment process" for breast cancer patients on reducing anxiety and increasing information individual and online group
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Newly admitted patients with breast cancer to Seyed al-Shohda hospital in Isfahan Age between 30 and 65 years Oncology specialist referral No serious psychiatric illness 35 / 5,000No substance abuse or addiction
Exclusion criteria:
The patient's unwillingness to participate in educational classes Participating in other treatment programs at the same time Inability to complete the online program
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign patients to each group, the Block balance method will be used in such a way that we use blocks of 4 letters to make random allocation sequences. For this purpose, we use WWW.randomization.com and select the number of letters in each block as 4 and select the total number of blocks, and finally we will have a list where the letter opposite each number indicates which group the person belongs to. In this study, the participants and the analyst will be blinded.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the study will be blinded. The analyst who will review and analyze the data will be blinded to the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of Isfahan Faculty of Medical Sciences, Collection of Re
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.ARI.MUI.REC.1402.289

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50.0
ICD-10 code description
Malignant neoplasm of nipple and areola

Primary outcomes

1

Description
anxiety
Timepoint
Pre-test, mediator, post-test and two-month follow-up
Method of measurement
STAI-HADS

2

Description
Knowledge of the treatment process
Timepoint
Pre-test, mediator, post-test and two-month follow-up
Method of measurement
EORTC QLQ-INFO25

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first group, the educational package "Awareness of the treatment process" for cancer patients will be presented in person, and the relevant follow-ups will be done and they will fill out the relevant questionnaires. The content of the training package for awareness of the treatment process (introduction of the head of Seyed al-Shohad Hospital and the definition of supportive care according to his words - introduction of the educational environment of supportive care in Seyed al-Shohad Hospital - introduction of the nutritionist and his initial talks - introduction of a part of the nutrition training class in supportive care - expert explanations Physiotherapy in supportive care - interview with one of the patients undergoing supportive care treatment about the quality of the training he receives - explanations of pain control and anesthesia specialist in supportive care - explanations of genetics specialist in supportive care - explanations of spirituality specialist in supportive care - expert explanations Self-care in supportive care - psychologist's explanation in supportive care - psychological discussions and supportive discussions of the patient's family, interview with the patient's companion about the use of supportive care training - invitation to use supportive care and necessary training)
Category
Other

2

Description
Intervention group: In the second group, people will receive the educational package "Awareness of the treatment process" for cancer patients online. They also fill out the questionnaire. The content of the training package for awareness of the treatment process (introduction of the head of Seyed al-Shohad Hospital and the definition of supportive care according to his words - introduction of the educational environment of supportive care in Seyed al-Shohad Hospital - introduction of the nutritionist and his initial talks - introduction of a part of the nutrition training class in supportive care - expert explanations Physiotherapy in supportive care - interview with one of the patients undergoing supportive care treatment about the quality of the training he receives - explanations of pain control and anesthesia specialist in supportive care - explanations of genetics specialist in supportive care - explanations of spirituality specialist in supportive care - expert explanations Self-care in supportive care - psychologist's explanation in supportive care - psychological discussions and supportive discussions of the patient's family, interview with the patient's companion about the use of supportive care training - invitation to use supportive care and necessary training)
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyed al-Shohad Hospital
Full name of responsible person
Dr narges rahmanian
Street address
Motahari ave
City
isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 31 3235 0210
Email
nrg-rahmanian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Neda yavari
Street address
Motahari Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
edo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Haniyeh salimi arshad moghadam
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 32371103
Email
salimimobina120@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr narges rahmanian
Position
Research Expert
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Motahari Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098 317928134
Email
nrg-rahmnian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Haniyeh salimi arshad moghaddam
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8134
Email
salimimobina120@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Sharing the information of participants in such a way that they are not identifiable
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
Specialists and researchers
Under which criteria data/document could be used
By obtaining permission from the researcher and informing her
From where data/document is obtainable
By sending an email to Haniyeh Salimi (salimimobina120@gmail.com)
What processes are involved for a request to access data/document
By sending an email to Haniyeh Salimi (salimimobina120@gmail.com)
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