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Design, implementation, and evaluation of an educational mobile application for the management of chemotherapy side effects in patients with leukemia

Protocol summary

Study aim
The effect of an educational application on the management of symptoms caused by chemotherapy will be investigated. If this educational method is effective and efficient, it will be used more in the future and improve the care of patients with leukemia.
Design
A semi-experimental study with a control group, parallel groups, investigating outcomes in 112 leukemia patients, single-blinded (statistical analysis), non-randomly allocation of the samples.
Settings and conduct
The samples will be allocated non-randomly into two control and intervention groups. First, the samples will enter the control group. Then, sampling of the intervention group will be initiated. Data collection will be done before and six weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The client's desire to participate, the client's access to a mobile phone with the Android operating system, having ability to read, write and work with a mobile phone, the client is only undergoing chemotherapy, a history of up to three cycles of chemotherapy. Exclusion criteria: The patient's unwillingness to continue participation, stopping the chemotherapy course, the patient's death.
Intervention groups
The intervention group will receive the symptom management training application. The educational content of this application will be approved by experts before being published among research units. Control group will receive routine cares and no new intervention will be given to them. The severity of chemotherapy symptoms will be measured before and after the intervention.
Main outcome variables
pain; fatigue; nausea; depression; anxiety; Drowsiness; appetite; feeling of well-being; shortness of breath

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230816059164N3
Registration date: 2024-08-23, 1403/06/02
Registration timing: prospective

Last update: 2024-08-23, 1403/06/02
Update count: 0
Registration date
2024-08-23, 1403/06/02
Registrant information
Name
Mohammad Mehdi Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 939 811 2685
Email address
mmehdirajabi1379@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation, and evaluation of an educational mobile application for the management of chemotherapy side effects in patients with leukemia
Public title
Design, implementation, and evaluation of an educational mobile application for the management of chemotherapy side effects in patients with leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness of the client to participate in the research Having access to a mobile phone with Android operating system Be able to read and write and to work with a mobile phone The client should be only undergoing chemotherapy and has not received other methods such as bone marrow transplant The client should have completed a maximum of three chemotherapy courses
Exclusion criteria:
The client's unwillingness to continue cooperation in each of the stages of the study It becomes impossible for the client to use the educational application for any reason The patient's chemotherapy course has been stopped Patient's death
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 112
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Group type will be hidden by letters A and B, so the data analyser will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2024-07-31, 1403/05/10
Ethics committee reference number
IR.TUMS.FNM.REC.1403.073

Health conditions studied

1

Description of health condition studied
Leukemia
ICD-10 code
C90.1
ICD-10 code description
Plasma cell leukemia

Primary outcomes

1

Description
Pain
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

2

Description
Fatigue
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

3

Description
Nausea
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

4

Description
Depression
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

5

Description
Anxiety
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

6

Description
Drowsiness
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

7

Description
Appetite
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

8

Description
Feeling of Well-Being
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

9

Description
Shortness of Breath
Timepoint
Before and six weeks after the intervention
Method of measurement
Edmonton Symptom Assessment Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive the symptom management training application. The educational content of this application will be approved by experts before being published among samples.
Category
Other

2

Description
Control group: The control group will receive routine cares and no new intervention will be given to them.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mehrshad Abbasi
Street address
Nuclear Medicine Department, Imam Khomeini Hospital Complex, Dr. Qarib street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6657 5102
Email
meabbasi@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotohi
Street address
6th floor of Research and Technology Vice-Chancellor, Central Organization of the University, corner of Quds St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 6105 4567
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rajabi
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Email
mmehdirajabi1379@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rajabi
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Email
mmehdirajabi1379@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rajabi
Position
Master's student in pediatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nusrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4424
Email
mmehdirajabi1379@gmail.com

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
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