Determining the effect of a telenursing program on the self-management of gastrointestinal symptoms in adolescents with cancer undergoing chemotherapy
Design
Clinical trial with control group, intervention group, randomized, on 66 patients.The data collected from all three stages will be analyzed using statistical analysis of variance tests in SPSS software.
Settings and conduct
After obtaining a written permission from Shahid Beheshti School of Nursing and Midwifery and Graduate Education Management, the student goes to the selected hospitals in Tehran with a letter of introduction and necessary permits for sampling. Then he will enter the research environment by introducing himself and explaining the objectives of the research and the steps of the work, with the approval of the authorities.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. The age of teenagers should be between 12-18 years.
2. Adolescents with leukemia, lymphoma, osteosarcoma and glioma cancer.
3. Adolescents have undergone chemotherapy at least once.
4. Have the ability to take care of themselves.
5. Have access to the Internet and an electronic device (computer, laptop, mobile phone and tablet).
6. Be fluent in Persian language and have the ability to answer the questionnaire questions.
Exclusion criteria:
1. Fill out the questionnaire incompletely.
2. During chemotherapy, the patient becomes ill and needs hospitalization.
3. During the treatment, due to the patient's condition, it is necessary to be transferred to another center.
Intervention groups
The intervention is planned in six sessions and the duration of each session will be 45 to 60 minutes.Then the data collected from all three stages will be analyzed.
Main outcome variables
Self-management of gastrointestinal symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030474N6
Registration date:2023-06-21, 1402/03/31
Registration timing:registered_while_recruiting
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Azam Shirinabadi Farahani
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21886553668
Email address
farahani1381@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-09-16, 1402/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a Telenursing Program on Self-Management of Gastrointestinal Symptoms in Adolescent with Cancer Undergoing Chemotherapy
Public title
The Effect of a Telenursing Program on Self-Management of Gastrointestinal Symptoms in Adolescent with Cancer Undergoing Chemotherapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents with leukemia, lymphoma, osteosarcoma and glioma.
Adolescents should be between 12-18 years old.
Adolescents have undergone chemotherapy at least once.
Have the ability to take care of themselves.
Having access to the Internet and an electronic device (computer, laptop, mobile phone and tablet).
Be fluent in Persian language and have the ability to answer the questionnaire questions.
Exclusion criteria:
Fill out the questionnaire incompletely.
During chemotherapy, the patient becomes ill and needs to be hospitalized.
During the treatment, due to the patient's condition, it is necessary to be transferred to another center.
Age
From 12 years old to 18 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
Complex permuted-block randomization method was used for randomization. In addition to establishing a balance in the number of people between the two groups, this method will prevent any prediction in order to determine the intervention sequence. The random sequence of blocks will be obtained through STATA software. In this study, 11 blocks of 6 are selected. The first block will be randomly selected and the next blocks will be selected sequentially from the first random selection. There are three people in the intervention group and three people in the control group in each block.
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 in Research Schools of Pharmacy, Nursing and Midwifery Shahid Beheshti University
Street address
Shahid Behesht School of Nursing and Midwifery-near Niayesh crossroads - Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-02-14, 1401/11/25
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.244
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
Z85.7
ICD-10 code description
Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues
Primary outcomes
1
Description
Self-management of gastrointestinal symptoms caused by chemotherapy
Timepoint
Before the intervention, immediately after the intervention, 1 month after the intervention
Method of measurement
The self-management questionnaire of gastrointestinal symptoms in adolescents was developed by the researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention is planned in six sessions and the duration of each session will be 45 to 60 minutes. In the first session, familiarization with the patients is taken before the test. In the second session, an explanation is given about cancer chemotherapy and side effects of the intervention group. In the third, fourth, and fifth sessions, nursing care is given for diarrhea, constipation, nausea, and vomiting, and in the sixth session, post-test, answering questions and reviewing materials, and after one month after the tool intervention, again It will be completed by all patients.Then the data collected from all three stages will be analyzed.
Category
Other
2
Description
Control group: There is no intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Dr.Mozhgan Hashemieh
Street address
Imam Hossein (AS) Medical Research Training Center., Shahid Madani St., Tehran.
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 7343 3000
Email
info@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Tajrish Shohadaye Hospital
Full name of responsible person
Dr. Farideh Mosavi
Street address
Tajrish Shohadaye Educational Medical Center., Shahadari St., Tajrish Square., Tehran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Behesti University of Medical Sciences, next to Taleghani hospital, Yaman Street, Shahid Chamran highway.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
farahani1381@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Behesht School of Nursing and Midwifery-near Niayesh crossroads - Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21886553668
Fax
+98 21 8820 2518
Email
farahani1381@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Behesht School of Nursing and Midwifery-near Niayesh crossroads - Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21886553668
Fax
+98 21 8820 2518
Email
farahani1381@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Behesht School of Nursing and Midwifery-near Niayesh crossroads - Valiasr St
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21886553668
Fax
+98 21 8820 2518
Email
farahani1381@sbmu.ac.ir
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
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
Title and more details about the data/document
The Effect of a Telenursing Program on Self-Management of Gastrointestinal Symptoms in Adolescent with Cancer Undergoing Chemotherapy
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
Research team
Under which criteria data/document could be used
After call with corresponding author
From where data/document is obtainable
farahani1381@sbmu.ac.ir
What processes are involved for a request to access data/document