This study was done to determine the effect of education on PRECEDE(PREDISPOSING, REINFORCING, ENABLING CONSTRUCTS IN EDUCATIONAL DIAGNOSIS AND EVALUATION) Model on chemotherapy side effects in patients with cancer under chemotherapy. This study is experimental, pre test-post test in control group and was done with selection and participation of 50 patients with cancer under chemotherapy referred to Aja hospitals in two groups (each group, n =25). After the samples were divided into two groups randomly, using the questionnaires based on PRECEDE Model and the Checklist questionnaire are determined the severity of chemotherapy side effects in patients Before the intervention in the experimental and control groups. Then comprehensive program of training was conducted based on Precede Model face-to-face and individually and According to the recognized needs of patients in the experimental group during two cycles of chemotherapy. Again the questionnaires based on Precede Model and Checklist questionnaire were completed the severity of chemotherapy side effects by experimental and control groups. The obtained data before and after the implementation of the program were analyzed in the experimental and control groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100530163N1
Registration date:2017-01-02, 1395/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Jalal Torkashvand
Name of organization / entity
AJA University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 217765400
Email address
torkashvandgalal@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Medical Science University Of AJA
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of training based on PRECEDE Model, on the control of chemotherapy side effects , in patients with cancer.
Public title
The Effect of training based on managing the chemotherapy side effects
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:: patients should be older than 18 years; able to communicate verbally with the researcher and have received a chemotherapy session and aren’t with other chronic diseases and they have the minimum literacy and also receiving the chemotherapy drugs as outpatient or inpatient in the oncology wards.
Exclusion criteria: unwillingness of patient to continue training and consulting sessions and are also required to use other treatments such as radiotherapy, photodynamic therapy, hyperthermia
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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 Aja University of Medical Sciences
Street address
Etemadzadeh Street
City
Tehran
Postal code
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
ir.ajaums.rec.1395.09
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
chemotherapy side effects
Timepoint
Before and one month after the intervention
Method of measurement
the questionnaires developed by researchers based on Precede Model and checklist questionnaire of symptoms related to chemotherapy
Secondary outcomes
1
Description
Needs assessment based on the predisposing factors, enabling factors, reinforcing factors of chemotherapy side effects
Timepoint
Before the intervention, 1 month after the intervention
Method of measurement
The needs assessment questionnaire based on structures of Precede Model
Intervention groups
1
Description
Intervention group: Training sessions will be based on the patient's needs, held for the intervention group according to the result of self-made questionnaire. in order to change knowledge, attitude and self-efficacy is used the different training methods such as short lectures, face-to-face and individually, questions and answers
Category
Behavior
2
Description
Control group: no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Aja hospital 501
Full name of responsible person
Jalal Torkashvand،Master of science nursing student
Street address
Faculty of Nursing, Kaj St, Shariati St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of AJA University of Medical Sciences
Full name of responsible person
Dr. Kamran Azma
Street address
AJA University of Medical Sciences, Etemadzadeh St., Fatemi St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of AJA University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Fahimeh Dadgari
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Etemadzadehi Street
City
Tehren
Postal code
Phone
+98 21 7750 0404
Fax
Email
Dadgary fahimeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University AJA
Full name of responsible person
Fahimeh Dadgary
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Etemadzadh Street
City
Tehran
Postal code
Phone
+98 21 7750 0404
Fax
Email
Dadgary.fahimeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Fahimh Dadgary
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Etemadzadeh Street
City
Tehran
Postal code
Phone
+98 21 7760 1533
Fax
+98 21 7750 0404
Email
Dadgary.fahimeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)