Protocol summary

Summary
The aim of of this study is effect of blend educations program on quality of life in patients with cancer.The present research is a clinical trial study with control group mono- center method. Including criteria were patient who had breast cancer or prostate cancer or colon cancer ; these who had chemotherapy or radiotherapy ; be in stage3 or less than stage3 ; they could writing or reading ; they could do with computer ; they did not have psaycology disease . Exclusion criteria include participants who didn’t have cited conditions or when their enter to end stage ؛ they didn’t like to continue in this plan ; when the patient died. All of patient were 64 in two groups intervention and control . Patients in intervention group receiving two group educational sessions with lecturing and watching an educational film on a video disc . The duration of each session did not exceed more than 90 minutes. Patients in control group receiving routine nursing care. ًQuality of life was assessed with EORTIC QLQ30 questionnaire at baseline, one and two month from baseline.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012720834N1
Registration date: 2015-06-08, 1394/03/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-06-08, 1394/03/18
Registrant information
Name
Maryam Bayati
Name of organization / entity
Ahvaz Juondy shapoor Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61333365071
Email address
bayati.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Juondy shapoor medical science
Expected recruitment start date
2014-10-07, 1393/07/15
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of blend educations program on quality of life in patients with cancer in Oncology ward of Shafa hospital in Ahvaz in 2014
Public title
Effect of education in quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: who had breast cancer or colon cancer or prostate cancer ; these who had chemotherapy or radiotherapy and bee in stage3 or less than stage3 ; they could writing or reading and didn’t have psychology disease ؛ they could do with computer . exclusion criteria: When their enter to end stage ؛ they didn’t like to continue in this plan ؛ when patient died.
Age
From 7 months old to 9 months old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 64
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
ٍEtical comity of Juodishapur of medical Sciences Ahvaz Univercity
Street address
Univercity of medical Sciences Ahvaz Juodishapur, Golestan street , Ahvaz
City
Ahvaz
Postal code
Approval date
2014-12-31, 1393/10/10
Ethics committee reference number
ajums.REC.1393.327

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
C50-C18-C6
ICD-10 code description
Malignant neoplasm of colon, Malignant neoplasm of breast, Malignant neoplasm of prostate

Primary outcomes

1

Description
quality of life
Timepoint
one mounth after intervention and two mounth after intervention
Method of measurement
EORTIC QLQ30

Secondary outcomes

empty

Intervention groups

1

Description
In intervention gruop, the patients have 2 classes about selfcare and one education CD take them. ٍEducational class is about selfcare in this patients. Education CD is review of class, too.
Category
Lifestyle

2

Description
Control group did not receive any education.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Shahram Baraz
Street address
Shafa hospital, avenue Golestan-Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Univercity of medical sciences Jundishapur Ahvaz
Full name of responsible person
Bahram Ebdali
Street address
Vice chancellor for research of Univercity of medical sciences Jundishapur Ahvaz , Univercity of medical sciences Jundishapur Ahvaz , Golestan avenue, Ahvaz
City
Ahvaz
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 Univercity of medical sciences Jundishapur Ahvaz
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
Univercity of medical Science Juondi shapoor Ahvaz
Full name of responsible person
Maraym Bayati
Position
Master of Nursing
Other areas of specialty/work
Street address
Golha bulding , 19Street ,Varzi Jonobi Street , Ferdos Gharb avenue , Tehran-
City
Tehran
Postal code
Phone
+98 21 4410 2649
Fax
Email
Bayati.ma@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Univercity of medical science Jundishapur Ahvaz
Full name of responsible person
shahram Baraz
Position
faculty member-master
Other areas of specialty/work
Street address
Golestan street-Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3373 8383
Fax
Email
shahrambaraz@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Juondy shapoor Medical science
Full name of responsible person
Shahram Baraz
Position
teaching in university
Other areas of specialty/work
Street address
Ahvaz
City
nursing faculity , Ahvaz Juondy shapoor Medical science , Golestan street
Postal code
Phone
+98 61 3373 8383
Fax
Email
shahrambaraz@ajums.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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