Determining the effect of educational intervention through social networks on Neuropathy in cancer patients
Design
Randomized clinical trial in two intervention and control groups and sampling using the available method and random block method (17 blocks of 4) and based on the randomization list prepared by a statistician. The sample size will be 34 people in each group.
Settings and conduct
The study is a randomized clinical trial in two intervention and control groups in patients of Ayatollah Khansari Hospital and Imam Reza Clinic. Both groups complete the questionnaires. The intervention group receives nursing training for one month in the form of messages, pictures and videos. After one month, the patients of both groups complete the questionnaires and after one month follow-up, at the end of the second month. After the reintervention, the relevant questionnaire will be completed by both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70, suffering from neuropathy caused by chemotherapy with the opinion of a specialist doctor, not suffering from other underlying diseases such as diabetes
Exclusion criteria:
Reluctance to participate in the study, not having cancer, not receiving drugs that cause neuropathy according to the specialist's opinion.
Intervention groups
The intervention group receives nursing training in the field of the disease for one month through one of the media messages. The messages sent are text messages with pictures and educational videos. At the end of the first and second month of the intervention, questionnaires are completed by both groups. At the end, the training materials will also be sent to the control group.
Main outcome variables
Reducing the severity of neuropathy and its complications, improving life and preventing frequent visits of patients, reducing the workload of the treatment staff
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240729062576N1
Registration date:2024-08-05, 1403/05/15
Registration timing:prospective
Last update:2024-08-05, 1403/05/15
Update count:0
Registration date
2024-08-05, 1403/05/15
Registrant information
Name
fatemeh shamsi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 0743
Email address
f.shamsi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2024-10-16, 1403/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a supportive educational intervention through virtual social networks on Neuropathy in cancer patients undergoing chemotherapy
Public title
Effect of education on Neuropathy caused by chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
70≥Age ≤ 18
Confirmation of cancer diagnosis by a specialist doctor
Passing at least one course of treatment with a chemotherapy drug that causes neuropathy and suffering from chemotherapy-induced neuropathy with the opinion of a specialist doctor
Ability to read and write
Access and ability to use virtual social network
Not suffering from known mental illnesses diagnosed by a doctor
Not suffering from other underlying diseases such as diabetes and rheumatoid arthritis
No drug addiction
Body mass index less than 40
Exclusion criteria:
Having diabetes and rheumatoid arthritis
Not using drugs that cause neuropathy with the opinion of a specialist doctor
Not having cancer disease with the opinion of a specialist doctor
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be conducted as a randomized clinical trial in two intervention and control groups. Sampling will be done using the available method and taking into account the inclusion criteria. After that, the samples will be divided into intervention and control groups by random allocation method (block randomization). The randomization list is prepared by a statistician using R software and provided to the researcher.
Sampling is done as available based on the study entry criteria, and the samples are selected by random block method (17 blocks of 4 AAAB, BBAA, BABA,...) and based on the randomization list provided to the researcher by the statistician. Control and intervention groups are assigned.
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, Basij Square, University Of Medical Sciences
City
Arak
Province
Markazi
Postal code
۶۹۴۱۷۳۸۴۸۱
Approval date
2024-06-16, 1403/03/27
Ethics committee reference number
IR.ARAKMU.REC.1403.122
Health conditions studied
1
Description of health condition studied
Chemotherapy-induced neuropathy
ICD-10 code
G13.0
ICD-10 code description
Paraneoplastic neuromyopathy and neuropathy
Primary outcomes
1
Description
Chemotherapy-induced Neuropathy
Timepoint
Measuring the severity of neuropathy before the intervention, one month and two months after the intervention
Method of measurement
Questionnaire to determine the severity of chemotherapy-induced neuropathy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group through one of the social media messages according to the patient's preference that has the ability to send messages in written, audio, video and video form, nursing training in the field of cancer, chemotherapy and neuropathy complications and its management to patients such as lifestyle healthy, daily exercises, diet, and self-care (such as daily examination of organs, use of protective equipment, how to take care of yourself, how to secure the living environment, etc.) for one month in the form of personal messages for each The individual will be sent and followed up. The messages sent are in the form of 2 to 3 text messages daily (8 am to 8 pm), along with related pictures and educational videos for a month. After sending educational messages, the participants are requested to send the phrase "message read" to the researcher at the end of the day after reading the message. In addition, in order to ensure the researcher's understanding of the concept of the sent educational content and the implementation of the training by the patients, at the end of each week, questions will be asked to the patients about the content sent in the 2nd to 3rd week. Continuous monitoring, counseling, answering possible questions of the patients and referral in the necessary cases will be done. After one month, both groups of patients will complete the relevant questionnaire and weekly follow-up will continue for one month, and at the end of the second month after the intervention, the relevant questionnaire will be completed again by both groups. At the end, the training material will be sent to the control group
Category
Lifestyle
2
Description
Control group: People who are in the control group do not receive any intervention and only complete the questionnaire three times, once before the start of the intervention for the opposite group, once one month after the start of the intervention and finally two months after the start of the intervention. And at the end of the study, the materials taught to the intervention group will also be sent to the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital and Emma Reza Clinic
Full name of responsible person
Fatemeh Shamsi
Street address
Arak - University Street
City
Arak
Province
Markazi
Postal code
3818649433
Phone
+98 86 3367 5001
Email
info_khansari@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Vice President Of Arak Medical Sciences Research And Technology
Street address
Basij Square, Arak University Of Medical Sciences, Vice President Of Research And Technology
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
Fatemeh Shamsi
Position
Master's student in medical surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
B11 complex, Lale 3 Ave, Mikhak St, Industrial City
City
Arak
Province
Markazi
Postal code
3819873987
Phone
+98 86 3313 0743
Fax
Email
f.shamsi@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Shamsi
Position
Master's student in medical surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
B11 complex, Lale 3 Ave, Mikhak St, Industrial City
City
Arak
Province
Markazi
Postal code
3819873987
Phone
+98 86 3313 0743
Fax
Email
f.shamsi@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Shamsi
Position
Master's student in medical surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
B11 complex, Lale 3 Ave, Mikhak St, Industrial City
City
Arak
Province
Markazi
Postal code
3819873987
Phone
+98 86 3313 0743
Fax
Email
f.shamsi@arakmu.ac.ir
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