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Effect of supportive care for pain using virtual networks on pain management and quality of life in patients with Gastrointestinal cancer

Protocol summary

Study aim
Determining the effect of pain supportive care program using virtual social network on pain management and quality of life of patients with gastrointestinal cancer
Design
This study is a randomized clinical trial. Participants will be randomly assigned to the intervention and control groups through block randomization technique.
Settings and conduct
The statistical population is all patients with cancer who are referred to Ayatollah Khansari Hospital and Imam Reza Clinic in Arak. For the intervention group, in addition to the section trainings, the trainings are sent as a message on the social network daily. In the control group, only section trainings are used. The instruments used include demographic questionnaire, standard 30-item quality of life questionnaire and the third questionnaire of pain self-management list.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: age ≥ 18, Individuals with gastrointestinal Cancer diagnosis undergoing treatment, obtaining a score above or above the pain questionnaire, ability to read and write, having a smartphone, access and ability to use virtual social media .
Intervention groups
The participants in the interventional group in addition to the hospital routin education will receive education messages through virtual social network about cancer, signs and sumptoms, tratments and its side effects, pain management(taking medications, relaxation techniques, massage therapy, music therapy and...)
Main outcome variables
Gender, age, marital status, level of education, type of treatment, stage of cancer,duration of illness, type of cancer, quality of life, pain management

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220128053848N1
Registration date: 2022-04-01, 1401/01/12
Registration timing: registered_while_recruiting

Last update: 2022-04-01, 1401/01/12
Update count: 0
Registration date
2022-04-01, 1401/01/12
Registrant information
Name
Mitra norbakhsh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3383 8268
Email address
mitranorbakhsh19@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supportive care for pain using virtual networks on pain management and quality of life in patients with Gastrointestinal cancer
Public title
Effect of supportive care virtual networks
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over eighteen years Definitive medical diagnosis of cancer being treated at least 6 months after diagnosis Get a score average of or above the pain questionnaire Ability to read and write Having a smart phone Access and ability to use and familiarize with the function of social media by the patient or a member of the patient's family
Exclusion criteria:
Patient's unwillingness to cooperate in research
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a block randomization method in which the randomization unit is performed individually. First, all 70 subjects are collected. In this clinical trial, 8 groups of blocks including 4 participants in the intervention group and 4 participants in the control group are divided into two groups. A random number table is used for randomization.
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
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.ARAKMU.REC.1400.192

Health conditions studied

1

Description of health condition studied
Diseases of the digestive system
ICD-10 code
2D8Y
ICD-10 code description
Malignant neoplasm metastasis in other specified digestive system organ

Primary outcomes

1

Description
Quality of life in this study The score obtained by the study participants from the standard questionnaire of 30 questions on quality of life of cancer patients
Timepoint
Before the intervention, one month after the intervention, three months after the intervention
Method of measurement
EORTC Quality of Life Questionnaire

2

Description
Pain management in this study is the score obtained by the patient from the pain self-management list.
Timepoint
Before the intervention, one month after the intervention, three months after the intervention
Method of measurement
PSMC questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to the hospital routine education, participants in the intervention group, will receive a set of educational messages about cancer, signs and symptoms, treatments and its side effects, pain management, and appropriate strategies to improve quality of life in the form of educational text messages, pictures and videos related to self-care and pain management. They will receive 3-5 messages daily (8 am to 8 pm) for one month. They will ask to send the message” I read the message” after seeing every message and answer the question about the weekly education content. The participants question will answer by researchers.
Category
Behavior

2

Description
Control group: Participants in this group receive hospial routin education.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Mitra Norbakhsh
Street address
the end of University Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
www.pr_khansari@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Saeed Changizi Ashtiani
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Web page address
https://research.arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak medical sciences university, Vice chancellor for research and technology
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
Mitra Norbakhsh
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The end of Shahid Fazlollah Nouri Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3817634719
Phone
+98 86 3405 2631
Email
mitranorbakhsh19@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
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Basij Square, Arak University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
۶۹۴۱-۷-۳۸۴۸۱
Phone
+98 86 3313 6055
Email
nazinejat@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mitra Norbakhsh
Position
master of sesinse student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
The end of Shahid Fazlollah Nouri Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3817634719
Phone
+98 86 3405 2631
Email
mitranorbakhsh19@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study will be published as a final report in the library of Arak University of Medical Sciences.
When the data will become available and for how long
The time period for accessing the data is available in September 2022.
To whom data/document is available
Teachers, students, and if the esteemed director of Ayatollah Khansari Hospital agrees, all clients who refer to this hospital can access the data.
Under which criteria data/document could be used
The necessary condition for using scientific data of this plan is that they should be diligent in preserving data and preventing data theft.
From where data/document is obtainable
For documentary access, you can refer to the library of Arak University of Medical Sciences or the library of Ayatollah Khansari Hospital in Arak.
What processes are involved for a request to access data/document
You can use this document first by referring to the mentioned libraries and after presenting your ID card and your position.
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