Protocol summary

Study aim
Effect of Implementing of discharge planning on quality of life and body mass index in patients with gastrointestinal cancer who undergoing chemotherapy
Design
Clinical trials with control group; available sampling
Settings and conduct
This clinical trial study was performed on 90 patients with cancer (esophagus, stomach, and colorectal cancer) who were studied in the study. They were divided into two groups: intervention and control groups. Data were collected using demographic characteristics, quality questionnaire Life is the checklist of the most common complications of chemotherapy. In the intervention group, the discharge schedule will be calculated from the time of admission and the body mass index will be calculated. One month after discharge, the quality of life questionnaire and body mass index of patients will be completed in two intervention and control groups.
Participants/Inclusion and exclusion criteria
The ability to communicate verbally; Stages 2 and 3; Access to the phone patient's death; reluctance to continue reading
Intervention groups
Filling out a quality of life questionnaire measuring body mass index; Assessing the patient with the most common complications of chemotherapy; Prioritizing the effects of life threatening; Training in the complications of the patient and his family for 45-60 minutes in three consecutive sessions; On the 3rd, 5th, and 15th days after the text message is sent to the patient's mobile phone. One month after the first measurement at the time of referral to the hospital, the quality of life of the patients will be measured using a questionnaire and body mass index. In the control group, filling in the questionnaire and measuring the BMI in the hospital, then measuring the quality of life and BMI one month after the first measurement
Main outcome variables
Discharge planing ; Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171007036612N3
Registration date: 2019-01-14, 1397/10/24
Registration timing: registered_while_recruiting

Last update: 2019-01-14, 1397/10/24
Update count: 0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Simin Sharifi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+54 33442481
Email address
sharifi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-03-06, 1397/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Implementing of discharge planning on quality of life and body mass index in patients with gastrointestinal cancer who undergoing chemotherapy hospitalized
Public title
Effect of discharge planning on quality of life of patients with gastrointestinal cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The ability to communicate verbal to receive instruction Knowledge of time and place Life-threatening conditions (dyspnea, intubation, etc.) The patient's pathology test confirmed the patient's gastrointestinal cancer There is no specific disease (chronic diseases, such as blood pressure-diabetes) Cancer stage 2 or 3 is in the patient's case It has mental and mental health At least once under chemotherapy To diagnose the disease at least one month past Access the phone The patient is suffering from esophageal cancer, stomach, and colorectal
Exclusion criteria:
Failure to cooperate and tolerate the patient's research conditions Patient's death during research Failure to visit the patient after a month
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Not 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 Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Dr Hesabi Sq, University Street, Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Approval date
2018-12-02, 1397/09/11
Ethics committee reference number
IR.ZAUMS.REC.1397.330

Health conditions studied

1

Description of health condition studied
Gastrointestinal Cancer, Esophageal Cancer, Gastric Cancer, Colorectal Cancer
ICD-10 code
C15.,C16.,
ICD-10 code description
C15-C26 Malignant neoplasms of digestive organs

Primary outcomes

1

Description
quality of life
Timepoint
At the beginning of the study, the month after the study
Method of measurement
The EROTIC core quality of life questionnaire

2

Description
Body Mass index
Timepoint
At the beginning of the study, the month after the study
Method of measurement
Digital weight and meter measurement scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: At the time of admission of patients in the hospital, at the first session, filling out a questionnaire on quality of life in these patients and measuring the BMI will be carried out. Then, the patients will be evaluated by the form of the most common complications of patients under American Cancer Chemo Chemotherapy and then prioritizing the complications. Based on life threatening and post-traumatic training on complications according to the complications noted to the patient and his family on the second day of education in the field of complications according to the complications noted to the patient and his family on the third day of education in the field of complications according to the complications noted to the patient and his family The training time will be 45-60 minutes per session. The third, fifth and fifth days after discharge, according to the priority of the specified complications, will be sent to the patients 'mobile phone. One month after the first assessment at the time of referral to the hospital, patients' quality of life was assessed using a questionnaire and body mass index using weight and size Will be done.
Category
Lifestyle

2

Description
Control group: In the control group, on the first day of admission, filling in the quality of life measurement and body mass index in the hospital, then measuring the quality of life and BMI will be done one month after the first assessment.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Ali Ibn Abi Talib
Full name of responsible person
Simin Sharifi
Street address
salamat Blvd.,Persian Gulf Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Fax
+98 54 3329 5575
Email
sharifi@zaums.ac.ir

2

Recruitment center
Name of recruitment center
Khatam al-Anbia hospital
Full name of responsible person
Simin Sharifi
Street address
Jam jamَ Ave
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9815733169
Phone
+98 54 3322 0501
Fax
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr.Bakhshani Normohammad
Street address
Zahedan University of Medical Sciences, Dr Hesabi Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Fax
+98 54 3329 5796
Email
bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Simin Sharifi
Position
Faculty of Nursing and Midwifery, Zahedan
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Department., Mashahir Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
sharifi@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Simin Sharifi
Position
Faculty of Nursing and Midwifery, Zahedan
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
. Nursing and Midwifery Department,Mashahir Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2481
Fax
+98 54 3344 2481
Email
sharifi@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Somayye charehjoo
Position
Master student of Medical- Surgical Nursing,
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Department., Mashahir Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 9693
Fax
Email
charehjoo.s@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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