Study objective: To determine the effects of applying King's theory on the self care self-efficacy in cancer patients undergoing chemotherapy. The study Design is pretest- post-test with a control group. Study population: All cancer patients undergoing chemotherapy in the oncology ward in the Shaheed Beheshti Educational and Medical Center in Hamadan. Inclusion criteria: be literate; 18-65 years old; and no history of mental illness and exclusion criteria: discontinuation of participation. After obtaining written informed consent, 60 patients will be randomly allocated to the experimental and control groups. At the first, the patients' level of self-care self-efficacy is determined by the questionnaire of the Strategies Used by Patients to Promote Health (SUPPH). The control group will care and educate as routine. The experimental group in addition to routine care and education will receive the nursing process according to the King’s theory with these phrases: 1- nursing assessment (the patient’s needs and goal identification); 2– Planning with the patient involvement (determine the nursing diagnosis, mutual goal setting goals, mutual the goal prioritizing and the working out sessions scheduling); 3– nursing implementation (conducting 6-10 interactive session over 10 to 15 minutes between the nurse and patient during 2 weeks, providing the self-care manuals for patients); 4– evaluation (determines the level of the goal achievement according to the patient’s affirmation by the goal attainment scale). Two weeks and two months later, both group patients' level of self-care self-efficacy is determined by the SUPPH questionnaire and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030612722N1
Registration date:2013-04-21, 1392/02/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-21, 1392/02/01
Registrant information
Name
Mohammad reza Varshoie
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 2530 7970
Email address
mr.varshoie@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of the King's theory applying on the self-care self-efficacy of the cancer patients undergoing chemotherapy
Public title
King's theory applying in the cancer patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria: patients with cancer undergone chemotherapy; between 18-65 years; least literate; no history of mental illness. The exclusion criteria: participate in the non-routine training and/or similar research during our study; inability to continue his/her participation in the study for any reason.
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:
60
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
Ethical Human Subject Review Board of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
Approval date
2013-02-14, 1391/11/26
Ethics committee reference number
D/P/16/35/9/4017
Health conditions studied
1
Description of health condition studied
Neoplasms
ICD-10 code
Z51.1,Z00-
ICD-10 code description
Chemotherapy session for neoplasm
Primary outcomes
1
Description
Self care self-efficacy
Timepoint
Before intervention, two weeks and two months after the intervention
Method of measurement
Strategies Used by Patients to Promote Health (SUPPH) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The experimental group: in addition to the routine care and education, the patients will receive the nursing process according to the King’s theory with these phases: 1- nursing assessment (the patient’s needs and goals identification); 2 – Planning with the patient's involvement (determine the nursing diagnosis, mutual goal setting, mutual goal prioritizing and working out sessions scheduling); 3 – nursing implementation (conducting 6-10 interactive sessions over 10 to 15 minutes between the nurse and patient during 2 weeks, providing the self-care manuals for patients); 4 –evaluation (determines the level of the goal achievement according to the patient’s affirmation by the goal attainment scale).
Control group: patients will be received routine cares and education.
Category
Other
2
Description
Control group: patients will be received routine cares and education.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Beheshti Educational and Medical Center
Full name of responsible person
Mohammadreza varshoie
Street address
Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Heidar Tavilani
Street address
Vice-Chancellor of Research and Technology, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Research and Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Mohammad reza Varshoie
Position
Condidate of Master Science Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 66 2530 0396
Fax
Email
mr.varshoie@umsha.ac.ir;m.varshoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Medical Surgical Nursing
Full name of responsible person
dr.Mahnaze Khatiban
Position
Nursing Ph.D
Other areas of specialty/work
Street address
Department of Medical Surgical Nursing, Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 1838 0755
Fax
Email
m-khatiban@umsha.ac.ir;mahnaz.khatiban@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Mohamma dreza Varshoie
Position
Condidate of Master Science Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery School, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 66 2530 0396
Fax
Email
mr.varshoie@umsha.ac.ir;m.varshoii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)