Protocol summary

Study aim
The effect of nutrition education on quality of life, sleep, weight changes, stress and anxiety, and depression in patients with gastric cancer after total gastrectomy
Design
The clinical trial in which the sampling is the random allocation and the minimum sample size required for each group was determined by dropping the samples with a probability of ten percent, 33 people for each group, and a total of 66 people. Data are analyzed using STATA version 15, MP version.
Settings and conduct
patient in Imam Khomeini Hospital after gastrectomy according to inclusion and exclusion criteria and personal satisfaction were included in the study and the group under consultation initially includes a face-to-face training session with the patient and preferably with close relatives after surgery and The stability of the situation is the adjustment of an individual diet plan for each patient on a weekly basis, during which the necessary follow-ups and answers to the patient's questions are performed during the week. The patient's companions will receive training every two weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of gastric cancer, age 20-65 years, total gastrectomy exclusion criteria: Patients with chronic diseases such as cardiovascular disease, mental illness or impaired consciousness, cancer metastasis to other organs (end-stage (IV) gastric cancer), diseases that may affect their nutritional status Like diabetes, long hospital stay.
Intervention groups
Nutrition counseling protocol interventions according to the American Cancer Nutrition Guideline, to treat them by a nutritionist who is responsible for research. the control group has no training program and receives only routine nursing care.
Main outcome variables
Quality of life; quality of sleep; general health; stress scale; anxiety and depression; assessment of nutritional status and weight changes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150902023861N9
Registration date: 2023-02-13, 1401/11/24
Registration timing: registered_while_recruiting

Last update: 2023-02-13, 1401/11/24
Update count: 0
Registration date
2023-02-13, 1401/11/24
Registrant information
Name
Mitra Zarrati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4814
Email address
zarrati.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of individual nutrition counseling and family education on quality of life, sleep, weight changes, stress, anxiety and depression in patients with gastric cancer after total gastrectomy
Public title
The effect of individual nutrition counseling and family education on improving life and weight changes in patients with gastric cancer after total gastrectomy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of gastric cancer Age between 20 to 65 years Total gastrectomy
Exclusion criteria:
Patients with chronic diseases such as cardiovascular,Mental illness or disturbance of consciousness Cancer metastasis to other organs (end stage (IV) gastric cancer) Diseases that may affect their nutritional status, such as diabetes Long-term hospitalization.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
For the random allocation of people, it will be done using the minimization method based on gender variables and in the form of balanced blocks. For this purpose, we have 6 pages of paper, on 3 of which the word I, which stands for Intervention, and on 3 of them, the word C, which stands for Control, is written. Then these are placed in a container and randomly extracted from this information box of these people until six pieces of paper are extracted from this package. Again, this operation is repeated until all the sample volume is taken. Then the participants in the selected blocks will be selected in a balanced way and based on gender according to the predetermined table. To balance the blocks based on sex, two pieces of paper written one of them with the word F, which stands for female, and the other with the word M, which stands for male, are then placed in the compartment and drawn randomly by replacing so that the ratio of women to men is considered to be 2 to 1 in the first block of 6 tuple and 1 to 2 in the next block of 6 tuple until the end, for this purpose the first half of the block of 6 tuple where the ratio of women to men is 2 to 1 If the first two people are randomly selected as men, in order to maintain the ratio of 2 to 1, we will consider the third person as a woman. We will determine the second half of the block based on the first half of the block. In the next block of 6 tuple, this time the ratio is reversed and the ratio of women to men is considered 1 to 2. Again, the lot is drawn by replacing and if the first person is a woman and the second person is a man, the third person is chosen as a woman to maintain the ratio, and this process continues until the end. The gender variable is considered a potentially confounding variable and the minimization method was used for the least confounding effect in the study. According to previous similar studies and research objectives, randomization will be done based on gender.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Educational and Guidance

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Hemmat expressway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-05-08, 1401/02/18
Ethics committee reference number
IR.IUMS.REC.1401.087

Health conditions studied

1

Description of health condition studied
gastric cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach

Primary outcomes

1

Description
Quality of Life
Timepoint
before intervention and 4, 8 weeks after intervention
Method of measurement
QLQ-STO22 and QLQ-C30 quality of life questionnaires

Secondary outcomes

1

Description
sleep quality
Timepoint
before intervention and 4 , 8 weeks after intervention
Method of measurement
Peters burg Sleep Quality Questionnaire (PSQI)

2

Description
General Health
Timepoint
before intervention and 4 , 8 weeks after intervention
Method of measurement
General Health Questionnaire (GHQ)

3

Description
Stress-Depression-Anxiety
Timepoint
before intervention and 4 , 8 weeks after intervention
Method of measurement
Stress Anxiety Depression Scale (DASS)

4

Description
Nutritional status of cancer patients
Timepoint
before intervention and 4 , 8 weeks after intervention
Method of measurement
The Patient-Generated Subjective Global Assessment Questionnaire

5

Description
Weight changes
Timepoint
before intervention and 4 , 8 weeks after intervention
Method of measurement
Weight (kg), waist and hip circumference (cm)

Intervention groups

1

Description
The intervention group receives individual nutrition counseling and training from family members. Patients in Imam Khomeini Hospital are admitted to the study after total gastrectomy according to the research criteria. After surgery and stabilization, a face-to-face training session is held with the patient and preferably with the participation of close relatives. After discharge, a weekly individual diet plan for each patient and training on how to deal with and reduce postoperative complications. The protocol procedure will be performed according to the American gastrectomy guideline. During the week, the necessary follow-ups and answering of the patient's questions will be done via video calls. In addition, the patient's companions will be trained once every two weeks. At the beginning of the study, patients are evaluated through questionnaires at weeks 4 and 8.
Category
Lifestyle

2

Description
Control group: Without any nutrition intervention, During hospitalization, patients routinely receive general nutrition education related to gastrectomy from the treatment staff. This group is also evaluated at the beginning of the study and during the 4th and 8th weeks.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr.Seyed Rohollah Miri
Street address
End of Keshavarz Boulevard, Dr. Gharib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8670 5503
Email
smiri@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Mitra Zarrati
Street address
Shahid Hemmat Highway between Sheikh Fazlollah Nouri and Shahid Chamran Iran University of Medical Sciences Razi International Conference Center Public Relations
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4814
Fax
Email
iumspr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
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
Iran University of Medical Sciences
Full name of responsible person
Dr.Mitra Zarrati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences, school of public health, nutrition department
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4814
Email
zarrati.m@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Zarrati
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4814
Fax
+98 21 8670 4745
Email
zarrati.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mitra Zarrati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition, School of Public Health, Iran University of Medical Sciences, next to the Milad hospital, the intersection of Sheikh Fazlallah and Shahid Chamran, Shahid Hemmat expressway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4814
Fax
Email
zarrati.m@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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