Protocol summary

Summary
This research is experimental, pretest-posttest control group with selection and participation of 70 patients with cancer receiving chemotherapy referred to hospitals where the two groups (each group, n = 35) will be done. After the samples were randomly divided into two groups, using questionnaires QLQ-C30, patients' quality of life in the intervention and control groups will be determined. The 8-session program based on Orem's self-care during a two-week training, counseling, 45-minute lecture, discussion group for the test will be conducted on the patients needs. QLQ-C30 questionnaire again, the groups will be published and will be completed. Data obtained before and after the implementation of the program and control groups will be analyzed.

General information

Acronym
none
IRCT registration information
IRCT registration number: IRCT2014112220041N1
Registration date: 2014-12-29, 1393/10/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-29, 1393/10/08
Registrant information
Name
Armin Zareiyan
Name of organization / entity
Military University of Medical Science (AJA)
Country
Iran (Islamic Republic of)
Phone
+98 21 7765 4000
Email address
a.zareian@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy-AJA university of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Self-Care Program Based on Orem Theory On Quality of Life of Cancer Patients Undergoing Chemotherapy in Military Personal Visiting AJA Hospitals.
Public title
Effect of orem self care program on cancer patient's quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Older than 18 years of age; They are able to communicate verbally ;Have received a chemotherapy session; Without other chronic diseases such as diabetes; Have at least read and write; Receiving chemotherapy as an outpatient or inpatient oncology unit.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
none

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
AJA University of medical Sciences
Street address
Shahid Etemadzadeh St.
City
Tehran
Postal code
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
MOHT-1393-5-4-7308

Health conditions studied

1

Description of health condition studied
Malignant neoplasm
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms

Primary outcomes

1

Description
Quality of life
Timepoint
Befor Intervention and 2 month after intervention
Method of measurement
QLQ-C30 Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
8 session program based on Orem's self-care during a two-week training, counseling, 45-minute lecture, discussion group to test the educational needs of patients
Category
Lifestyle

2

Description
Intervention will not occur in the control group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
AJA University of Medical Sciences
Full name of responsible person
Armin Zareiyan
Street address
Etemadzadeh St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
AJA University Of medical Sciences
Full name of responsible person
Aliyari Shahla
Street address
Dr.Shariati st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Zareiyan, Armin
Position
PhD
Other areas of specialty/work
Street address
Dr.Shariati St.
City
Tehran
Postal code
Phone
+98 21 7760 1533
Fax
Email
a.zareian@ajaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Zareiyan,Armin
Position
PhD
Other areas of specialty/work
Street address
Shariati St.
City
Tehran
Postal code
Phone
+98 21 7765 4000
Fax
Email
a.zareian@ajaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
AJA University of Medical Sciences
Full name of responsible person
Zareiyan,Armin
Position
PhD
Other areas of specialty/work
Street address
Dr.Shariati St.
City
Tehran
Postal code
Phone
+98 21 7765 4000
Fax
+98 21 7760 1533
Email
a.zareian@ajaums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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