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The effect of continuous care model on the side effect of chemotherapy in breast cancer patients

Protocol summary

Summary
this study aimed to determine the effect of continuous care model on the management of chemotherapy side effect like sleep disorder, fatigue, pain, nasea and body image.this study is a randomized clinical trial on patients suffering from breast cancer who reffered to shafa and golestan hospital ( Ahvaz, Iran). after reviewing the characteristics of the samples in the research environment, among patients eligible for the study, selected couple samples among similar samples and each with a random of two groups will be assigned. then four days after chemotherapy session, demographic, sleep quality, fatigue, pain, nasea and body image questionnaires for patients completed by investigator and will be performed in all cases. then two months continuous care model in intervention group will be implemented that including four orientation stage, making sensitive, control and evaluation.there is no intervention in control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013070613802N2
Registration date: 2013-09-25, 1392/07/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-25, 1392/07/03
Registrant information
Name
Mahsa Imanian
Name of organization / entity
Ahvaz Jundishapor University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 79 1227 7642
Email address
imanian.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapor University Of Medical Sciences
Expected recruitment start date
2013-07-30, 1392/05/08
Expected recruitment end date
2013-09-30, 1392/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous care model on the side effect of chemotherapy in breast cancer patients
Public title
decrease of side effect of chemotherapy by continuous care model
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being aware of the time and place; The lack of a clear and well-known sleep disorders, pain, fatigue, nausea and vomiting in the patient's medical history is mentioned; Lack of mental and brain diseases in the patient's medical history is mentioned (Thease has the effect of variables);The absence of severe dyspnea in patients; Not receiving the sleep-disrupting drugs such as diuretic drugs, antidepressants, and amphetamines and inotropes at night; Age 65-25 years; known Persian language; Patients who have a minimum of one and a maximum of 5 sessions of chemotherapy; Patients with stage II, III and IV disease. Exclusion criteria: Get an anesthetic and narcotic drugs during the study; Patient's unwillingness to continue participation in the study; Acute complications during the study; Get the sleep-disrupting drugs such as diuretic drugs, antidepressants, and amphetamines and inotropes at night; Need CPR during the intervention
Age
From 25 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
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
Ahvaz Jundishapor University Of Medical Sceince
Street address
Autobahn Golestan, Ahvaz
City
Ahvaz
Postal code
Approval date
2013-07-06, 1392/04/15
Ethics committee reference number
ajums.REC.1392.36

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50.0, C50
ICD-10 code description
Malignant neoplasm of Breast

Primary outcomes

1

Description
sleep quality
Timepoint
beginning of study, two months after intervention
Method of measurement
pittsburgh sleep quality Questionnaire

2

Description
pain
Timepoint
beginning of study, two months after intervention
Method of measurement
pain assessment questionnaire

3

Description
fatigue
Timepoint
beginning of study, two months after intervention
Method of measurement
fatigue summarized check list

4

Description
nasea
Timepoint
beginning of study, two months after intervention
Method of measurement
nasea assessment questionnaire

5

Description
body image
Timepoint
beginning of study, two months after intervention
Method of measurement
Body image scale

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Continuous Care Model (Including orientation, sensitization, monitoring and evaluation) in the intervention group and measurements related to sleep, fatigue, pain,nasea and body image
Category
Prevention

2

Description
control group: in the control group the patients will be received only routine cares
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Dr Nasrin Elahi
Street address
School Of Nursing And Midwifery, Ahvaz Jundishapor University Of Medical Sceinces
City
Ahvaz

2

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr Nasrin Elahi
Street address
School Of Nursing And Midwifery, Ahvaz Jundishapor University Of Medical Sceinces
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapor University Of Medical Sceinces
Full name of responsible person
Dr Mostafa Feghhi
Street address
Golestan Autobahn, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapor University Of Medical Sceinces
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
Ahvaz Jundishapor University Of Medical Sceinces
Full name of responsible person
Mahsa Imanian
Position
Post Graduate Student Of Nursing
Other areas of specialty/work
Street address
Shahrake Enghelab, jahrom
City
Jahrom
Postal code
Phone
+98 79 1227 7642
Fax
Email
mahsa.imanian@gmail.com imanian.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapor University Of Medical Sceinces
Full name of responsible person
Nasrin Elahi
Position
Doctrate
Other areas of specialty/work
Street address
Nursig And Midwifery School Of Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1770 2236
Fax
Email
elahi_118@yahoo.comnasrinelahi137@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapor University Of Medical Sceinces
Full name of responsible person
Mahsa Imanian
Position
Post Graduate Student Of Nursing
Other areas of specialty/work
Street address
Jahrom
City
Jahrom
Postal code
Phone
+7 912277642
Fax
Email
mahsa.imanian@gmail.com imanian.m@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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