Protocol summary

Study aim
The effect of nutrition education through virtual social networks on nutritional status and quality of life of patients with colorectal cancer is determined.
Design
The interventional study with a control group, randomized block design using a random number table without blinding, perform on 80 patients with colorectal cancer (40 participants in each groups). Nutrition education is done through virtual social networks for the intervention group, and the control group only receives routine hospital education.Blinding was not done in this study.
Settings and conduct
This study is conducted in Ayatollah Khansari Hospital and Imam Reza Clinic in Arak. The intervention group receives nutrition education via virtual social network for one month, and the control group only receives routine hospital education to determine the effect of the intervention on the nutritional status and quality of life of patients with colorectal cancer. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 25 and 75 years. Colorectal cancer diagnosis. Undergoing chemotherapy. At least 2 months have passed since the diagnosis of colorectal cancer in patients Capable to perform reading and writing Have a smart phone. Patient or his/her family should have the ability to use virtual social networks. Do not suffer from mental illness. Do not suffer from diseases that cause malnutrition. The patient is not addicted to drugs. Exclusion criteria: Unwillingness to participate in the study.
Intervention groups
The intervention group is patients with colorectal cancer undergoing chemotherapy group who receive nutrition education through virtual networks. Control group: This group does not receive the training through virtual networks, but they receive the routine training of the department.
Main outcome variables
Quality of life knowledge and nutritional status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220604055074N1
Registration date: 2023-01-12, 1401/10/22
Registration timing: retrospective

Last update: 2023-01-12, 1401/10/22
Update count: 0
Registration date
2023-01-12, 1401/10/22
Registrant information
Name
Masoumeh Davoodabadi farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 1640
Email address
madavoodabadi9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
2020-01-20, 1398/10/30
Actual recruitment end date
2021-01-19, 1399/10/30
Trial completion date
2021-01-19, 1399/10/30
Scientific title
The effect of nutrition education using virtual social networks on nutrition status and quality of life of patients with colorectal cancer
Public title
The effect of virtual education and support on nutrition of patient with colorectal cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Medical diagnosis of colorectal cancer Undergoing chemotherapy for at least 2 months after the definitive diagnosis Ability to read and write having cell phones and knowing how to use Familiarity with social media performance by the patient or the patient's family Absence of mental illness Don't having underlying diseases causing malnutrition No drug addiction
Exclusion criteria:
Unwillingness to participate in the study
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Recruiting was done when patients went to the hospital and clinic for chemotherapy. Then the samples were randomly divided into two groups of 40 people with random allocation in the intervention (A) and control (B) groups. At first, the blocks of four were defined as follows: ABAB, BBAA, BABA, BAAB, AABB , ABBA, etc. and were placed in the envelope and numbered. The blocks were determined using a table of random numbers, and people were placed in two intervention and control groups according to A and B. Patient A was placed in the supportive educational intervention group through virtual social networks and patient B was placed in the control group.
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 Arak University of medical Sciences
Street address
Arak University of Medical Sciences School of Nursing, Payambar-e Azam Complex, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2019-10-12, 1398/07/20
Ethics committee reference number
IR.ARAKMU.REC.1398.201

Health conditions studied

1

Description of health condition studied
Colorectal cancer
ICD-10 code
c18
ICD-10 code description
Malignant neoplasm of colon

Primary outcomes

1

Description
nutritional status score with PG-SGA questionnaire
Timepoint
At the beginning of the study (before the intervention) and one month after the educational intervention
Method of measurement
Patient-Generated Subjective Global Assessment (PG-SGA)

Secondary outcomes

1

Description
Quality of life score in colorectal cancer
Timepoint
At the beginning of the study (before the intervention) and one month after the educational intervention
Method of measurement
Colorectal cancer specific quality of life questionnaire (EORTC QLQ-CR29)

Intervention groups

1

Description
Intervention group: they receive educational content in form of educational text messages (2 to 3 messages), audio messages, images and related videos (8 am to 8 pm daily) for one month through a virtual social network. After sending the messages, the participants are requested to send the sentence "the message has been read" to the researcher at the end of the day after reading the messages. In addition, to ensure the participants understanding of the concept of the sent educational content , at the end of each week, patients were asked 2 to 3 questions about the sent content.
Category
Other

2

Description
Control group: They received the routine education of the hospital. After one month and after completing the questionnaires, the nutrition educational booklet was also provided to the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Parsa Rostami
Street address
Ayatollah Khansari Hospital, University Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5007
Email
madavoodabadi9@gmail.com

2

Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Maysam Bakhshi
Street address
Imam Reza Clinic, Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3813899589
Phone
+98 86 2402 0021
Email
madavoodabadi9@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mehdi Salehi
Street address
Deputy of research and technology, Medical Sciences University Complex, Markazi Province, Arak, Basij Square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3532
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Davoodabadi Farahani
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Third floor، Blue Wing,School of Nursing, Medical Sciences university Complex, Sardasht
City
Arak
Province
Markazi
Postal code
6941738481
Phone
+98 66 3417 3524
Email
madavoodabadi9@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazi Nejat
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Third floor، Blue Wing,School of Nursing, Medical Sciences university Complex, Sardasht
City
Arak
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3524
Email
n.nejat@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Davoodabadi Farahani
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Third floor، Blue Wing,School of Nursing, Medical Sciences university Complex, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
madavoodabadi9@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potentially shareable data after de-identification of individuals and information on primary outcomes
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers working in academic and scientific institutions can request to receive non-identifiable personal data or other documents.
From where data/document is obtainable
To receive the data, send an email to the responsible author, Dr. Nazi Nejat N.nejat@arakmu.ac.ir
What processes are involved for a request to access data/document
After receiving the request email, the data will be sent to the requester within one working week.
Comments
Loading...