Protocol summary

Study aim
Determining the Effect of Learning by Learning Method on Problem Solving on Quality of Life in Patients with Breast Cancer
Design
The sampling method was available in this way. By referring to the Oncology Department of Tohid Hospital in Sanandaj, the number of patients admitted to the diagnosis of breast cancer was determined and completed until a sample size (50 patients) was completed, then the sample They were randomly assigned to case and control groups based on random numbers.
Settings and conduct
First, the quality of life and healthy lifestyle questionnaires were assessed in both groups. Then, participants in the case group were trained for five sessions of one to one and a half hours based on a planned program based on problem-solving learning in groups of 4 to 5. During this period, no training was given to the control group. Finally, after completing the intervention, the samples again completed the questionnaires in two groups.
Participants/Inclusion and exclusion criteria
Criteria for inclusion in the study included age range of 20-60 years, patient collaboration, compliance with the informed consent form, participation in the training program by the participants, lack of history of chronic disease, drug use, mental illness and having appropriate physical conditions. Exclusion criteria included the lack of cooperation and dissatisfaction with the company in the study, as well as severe physical conditions and the history of chronic disease, drug use and mental illness.
Intervention groups
The case group participants were trained for five sessions of one to one and a half hours at the time of admission based on a program designed based on problem-solving learning in groups of 4 to 5. During this period, no training was given to the control group. The educational content of this study in the general aspect of cancer include: fatigue, nausea and vomiting, pain, painful breathing, sleep disturbances, anorexia, diarrhea and constipation, and economic problems, in the specific aspect of the cancer including symptom scales, sexual function, imagination of the future And self-concept in the field of lifestyle, including dimensions of health accountability, physical activity, nutrition, spiritual growth, interpersonal relationships, and stress management. The intervention method was also carried out in 8 steps: First, the basic information about the problem to be taught was explained by the trainer, then the patient was asked to make the hypotheses based on his previous knowledge and experience 2. The instructor provided the information in response to the patient's questions. 3. The educator wanted the patient to address his major problems with regard to the studies and information collected. 4- The educator asked the patient to plan and say what he was saying. 5. The educator wanted the patient to have scientific defects. Which in his ability to understand the issue was raised.6 The educator gave the patient the opportunity to work on the problem on the basis of the method he chose and guided the patient, After review, he expects the patient to discuss the issue by choosing his own and provide solutions and how to implement the remedies. 7 The patient will explain any changes that have been made to the problem, and according to priorities, an issue. In detail, the controversy was discussed. The patient at this stage did what he did during the independent study and provided the new information specifically The specific question, explained why this information is particularly useful.
Main outcome variables
The quality of life of breast cancer in functional dimensions, quality of life, breast cancer in symptomatic dimensions, lifestyle in breast cancer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121015011122N2
Registration date: 2018-03-14, 1396/12/23
Registration timing: retrospective

Last update: 2018-03-14, 1396/12/23
Update count: 0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
Hossein Feizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3377 2638
Email address
h_feyzi65@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2016-12-20, 1395/09/30
Trial completion date
empty
Scientific title
The effect of problem- based learning on quality of life and life style of patients with breast cancer
Public title
the effect of problem- based learning on quality of life and life style
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of between 20 and 63 years patient cooperation the completion of the informed consent form, participation in the training program by the participants absence of a history of chronic disease, drug use, mental illness theand having appropriate physical conditions
Exclusion criteria:
Incomplete cooperation of samples dissatisfaction with the company in the research severe physical conditions and the history of chronic disease, drug use and mental illness
Age
From 22 years old to 63 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly divided into case and control groups based on random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
University of Medical Sciences, School of Nursing and Midwifery, Kordestan, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Approval date
2016-10-30, 1395/08/09
Ethics committee reference number
IR.MUK.REC.1395/235

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C44.501
ICD-10 code description
Unspecified malignant neoplasm of skin of breast

Primary outcomes

1

Description
quality of life
Timepoint
Before and after the intervention
Method of measurement
Standard Quality of Life Quality Questionnaire, Breast Cancer Quality of Life Quality Questionnaire and Health Promotion Lifestyle Standard Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: this group was trained for five sessions of one to one and a half hours at the time of admission based on a program designed based on problem-solving learning in groups of 4 to 5. The educational content of this study in the general aspect of cancer include: fatigue, nausea and vomiting, pain, painful breathing, sleep disturbances, anorexia, diarrhea and constipation, and economic problems, in the specific aspect of the cancer including symptom scales, sexual function, imagination of the future And mental self-concept in the context of lifestyle, including dimensions of health accountability, physical activity, nutrition, spiritual growth, interpersonal relationships, and stress management .
Category
N/A

2

Description
Control group: no intervention was performed in the control group during the training period in the experimental group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid Hospital
Full name of responsible person
Hossein Feizi
Street address
University of Medical Sciences, School of Nursing and Midwifery, Kordestan, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3377 2638
Email
h_feyzi65@yaahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Hossein Feizi
Street address
University of Medical Sciences, School of Nursing and Midwifery, Kordestan, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3377 2638
Email
h_feyzi65@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
hossein feizi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences, School of Nursing and Midwifery, Kurdestan, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3377 2638
Email
h_feyzi65@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
hossein feizi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sanandaj University of Medical Sciences, Faculty of Nursing and Midwifery
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3377 2638
Email
h_feizi65@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
hossein feizi
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sanandaj University of Medical Sciences, Faculty of Nursing and Midwifery
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3377 2638
Email
h_feyzi65@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 3 months after printing the article
To whom data/document is available
Researchers working in academic and non-academic institutions
Under which criteria data/document could be used
For use as a research tool, as a discussion, use the research method
From where data/document is obtainable
Hossein Feizi, via personal e-mail (h_feyzi65@yahoo.com) and academic email (feizi.h@muk.ac.ir) and Kurdistan, Sanandaj, Medical Sciences University, Nursing and Midwifery Faculty, 08733772638, 09181731736
What processes are involved for a request to access data/document
Send an email from the contact, receive and check the sent email, answer after a week
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