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Determining the Effect of Health Promotion Educational Support Program on the Quality of Life, Hope and Family Support of Women with Breast Cancer in the Stage of Surgery and Chemotherapy

Protocol summary

Study aim
Determining the Effect of a Supportive Educational Program to Promote the Health of Women with Breast Cancer on the Quality of Life, Hope and Family Support during Surgery and Chemotherapy
Design
A clinical trial with a control group, non-parallel groups, single-blind, non-randomized, phase 3 on 304 patients with breast cancer in the stages of chemotherapy and surgery
Settings and conduct
The research environment will be Omid Hospital in Mashhad. The intervention includes the implementation of the health promotion program, which includes educational, support and follow-up sessions. First, sampling of the control group will be done, then the program will be implemented for the intervention group and the questionnaires will be completed by the implementation group
Participants/Inclusion and exclusion criteria
The patient is a new case of breast cancer; He is a candidate for mastectomy surgery or a candidate for a chemotherapy protocol; Be a woman; Be between the ages of 25 and 65; Be Iranian; Ability to read and write in Farsi language.
Intervention groups
First, the sampling of the control group will be done independently until a sufficient sample size is reached for both surgery and chemotherapy groups. Control groups will receive only routine care. Then the intervention, which consists of the implementation of an educational support program for health promotion, will be implemented for two groups of surgery and chemotherapy. For both chemotherapy groups (intervention and control) questionnaires related to quality of life, hope and family support on dates 0, 1 and 3 months after the start of treatment and for both surgery groups (intervention and control) questionnaires related to Quality of life, hope and family support will be completed on the day of discharge and 8 weeks after surgery.
Main outcome variables
Quality of life, hope and family support

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230510058141N1
Registration date: 2023-08-21, 1402/05/30
Registration timing: prospective

Last update: 2023-08-21, 1402/05/30
Update count: 0
Registration date
2023-08-21, 1402/05/30
Registrant information
Name
samane raffe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3890 9438
Email address
rafes991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the Effect of Health Promotion Educational Support Program on the Quality of Life, Hope and Family Support of Women with Breast Cancer in the Stage of Surgery and Chemotherapy
Public title
Determining the Impact of the Health Promotion Program for Women with Breast Cancer on the Quality of Life, Hope and Family Support During Surgery and Chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is a new case of breast cancer. She is a candidate for mastectomy surgery or a candidate for a chemotherapy protocol. The patient is female. The patient must be between 25 and 65 years old. Be an Iranian patient. The patient should be able to read and write in Persian language.
Exclusion criteria:
Does not Agree to Participate in the Research.
Age
From 25 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 304
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this research, the research participants will include breast cancer patients and will be blinded. In this way, while providing full explanations of the research, the patient will be told that the patient will be placed in one of the two control or intervention groups. It will also be explained that if the patient is placed in the control group, he will receive routine interventions and care. Then informed consent will be obtained.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing & Midwifery; Mashhad University of Medical Sciences
Street address
No. 5, Ceraghchi 17 St., Saremi 52 Ave., VakilAbad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178835442
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.112

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant Neoplasm of Breast

Primary outcomes

1

Description
The score obtained from the EORCT QLQ30 quality of life questionnaire
Timepoint
In surgery patients: at times (discharge day) 0 and 6 weeks after surgery and in chemotherapy patients at times 0 (first session of chemotherapy), one week later and 3 months later
Method of measurement
EORCT quality of life QLQ c30 questionnaire

2

Description
Hope: the score obtained from the Hearth Hope Index tool
Timepoint
In surgery patients: at times (discharge day) 0 and 6 weeks after surgery and in chemotherapy patients at times 0 (first session of chemotherapy), one week later and 3 months later
Method of measurement
Hearth Hope Index tool

3

Description
Family support: score obtained from the ICE-FPSQ Perceived Family Support Questionnaire
Timepoint
In surgery patients: at times (discharge day) 0 and 6 weeks after surgery and in chemotherapy patients at times 0 (first session of chemotherapy), one week later and 3 months later
Method of measurement
ICE-FPSQ Perceived Family Support Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The intervention includes the implementation of the health promotion program. This program consists of:Holding at least one training session for 30 minutes to justify the laboratory staff to refer the patient to the medical clinic in order to provide the appointment of the doctor to the patient. Holding at least one training session for 30 minutes to justify the reception staff of the clinic to facilitate the doctor's visit to the patient. Telephone follow-up by making at least 2 phone calls to the patient by the nurse working in the health education nursing clinic according to the defined process up to 48 hours after receiving the pathology answer and answering the patient's questions in the form of telephone consultation to follow up the referral and start the treatment. Development of electronic education by updating the website of Omid Hospital by providing up-to-date scientific content, education through smart phones by making it possible to access up-to-date and scientific educational content by scanning the QR code on the educational content. Development of scientific and up-to-date educational content in the application available in Omid Hospital. Making it possible to access educational content through Bluetooth. Holding a face-to-face training session for 15 minutes for the patient and family on how to access the educational materials available on the Omid Hospital website and training the patient and family on how to receive the educational materials by scanning the QR code.
Category
Lifestyle

2

Description
Control group: Providing routine and usual educational, care and treatment interventions
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid hospital
Full name of responsible person
Dr Seyed Amir Aledavood
Street address
Omid Hospital, Kohsangi Ave,
City
Mashhad
Province
Razavi Khorasan
Postal code
9176613775
Phone
+98 51 3842 6082
Fax
+98 51 3842 8622
Email
aledavoodA@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Talat khadivzade
Street address
Faculty of Nursing and Midwifery, Ebne Sina Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Samane Raffe
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, Saremi 52 Ave., Cheraghchi 17., Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9178835442
Phone
+98 51 3890 9438
Email
Rafes991@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Heshmati Nabavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
38411538
Email
HeshmatiNf@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samene Raffe
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ebne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Rafes991@mums.ac.ir

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
Undecided - It is not yet known if there will be 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 data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Health and treatment centers
From where data/document is obtainable
Applicants can refer to the library of Mashhad College of Nursing and Midwifery located on Ebne Sina Street to receive documents. Or call 05138591511 ext. 253 Mrs. Nowrozi.
What processes are involved for a request to access data/document
Immediately by visiting the Mashhad Nursing and Midwifery Faculty library in person or online
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