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Evaluation of the effect of using mobile application on the management of chemotherapy side effects and quality of life in patients with breast cancer

Protocol summary

Study aim
Determining the effect of using a mobile application on the management of chemotherapy side effects and quality of life in breast cancer patients
Design
A controlled, parallel-group, double-blind, randomized, phase 2 clinical trial on 72 patients using Randomize.Com for randomization.
Settings and conduct
This research is presented in Omid Hospital of Mashhad as the study center of the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female patients, at least 18 and at most 60 years old, with the ability to read and write, patients with a smartphone capable of using the application, patients undergoing chemotherapy, willing to participate in the study. Exclusion criteria: patients with chronic mental problems and psychiatric diagnoses including major depressive disorder and anxiety disorders, presence or history of uncontrolled medical diseases except breast cancer, patients participating in another study, patients receiving radiotherapy and biotherapy at the same time they receive
Intervention groups
Receiving chemotherapy in the usual way, simultaneously using the application for a period of 4 weeks At the beginning of the study, the complications of the participating patients, as well as their quality of life are evaluated through a questionnaire in both the intervention and control groups, then they are re-evaluated again after 4 weeks. Finally, by analyzing and comparing the findings obtained in patients of both groups, we will examine the impact of using the application on the management of complications and quality of life in breast cancer patients undergoing chemotherapy.
Main outcome variables
Complications management Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230402057801N1
Registration date: 2023-05-12, 1402/02/22
Registration timing: registered_while_recruiting

Last update: 2023-05-12, 1402/02/22
Update count: 0
Registration date
2023-05-12, 1402/02/22
Registrant information
Name
Marziyeh Raee Mehneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3551 0790
Email address
raeem4002@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of using mobile application on the management of chemotherapy side effects and quality of life in patients with breast cancer
Public title
Evaluating The Effect of Using An Mobile-Application on The Management of Chemotherapy Complication and Quality of Life in Breast Cancer Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Literate patients Patients diagnosed with breast cancer Patients undergoing chemotherapy Patients with smartphones that can use this application Ability and willingness to participate in the study
Exclusion criteria:
Patients with chronic mental problems and psychiatric diseases, including major depressive disorder and anxiety disorders Presence or history of uncontrolled medical conditions other than cancer Patients participating in another study related to symptom management Patients who undergo radiotherapy and biotherapy at the same time as chemotherapy
Age
From 18 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
In order to evaluate the impact of the designed application, patients who have been diagnosed with breast cancer and are receiving chemotherapy in Omid Hospital of Mashhad, who also meet the criteria for entering our study, were randomly divided into two control and intervention groups using the block method. are placed (randomization will be done using the envelope method, the said sequence will be generated using the randomize.com site)
Blinding (investigator's opinion)
Single blinded
Blinding description
In connection with the blinding of the participants, the participants of each group will remain unaware of the existence of the other study group as well as the existence of the application. In connection with the data analyst, after collecting the data, we will give data related to each group to the data analysts without specifying which group they belong to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ferdowsi University
City
Mashhahd
Province
Razavi Khorasan
Postal code
9351991358
Approval date
2023-03-04, 1401/12/13
Ethics committee reference number
IR.MUMS.FHMPM.REC.1401.198

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Evaluation of complications and quality of life of the participants
Timepoint
At the beginning of the study (before the start of the intervention) and 4 weeks after
Method of measurement
using two standard questionnaires QLQ-BR23 and

Secondary outcomes

1

Description
Evaluation of the satisfaction of the participants in the intervention group in connection with the use of the application
Timepoint
At the beginning of the study and 4 weeks after using the application
Method of measurement
Using a standard satisfaction questionnaire

Intervention groups

1

Description
Intervention group: Receiving chemotherapy in the usual way, along with using the application for 4 weeks at the beginning of the study, the complications of the participating patients, as well as their quality of life, were evaluated through a questionnaire in both the intervention and control groups, and it was re-evaluated again after the intervention period of 4 weeks. Finally, by analyzing and comparing the findings obtained in patients of both groups, we will examine the impact of using the application on the management of complications and quality of life in breast cancer patients undergoing chemotherapy.
Category
Lifestyle

2

Description
Control group: Receiving chemotherapy in the usual way, at the same times as before and as it was received in the past, without any intervention from our side and according to the hospital's protocol and past routine at the beginning of the study, the complications of the participating patients, as well as their quality of life, were evaluated through a questionnaire in both the intervention and control groups, and it was re-evaluated again after the intervention period of 4 weeks. Finally, by analyzing and comparing the findings obtained in patients of both groups, we will examine the impact of using the application on the management of complications and quality of life in breast cancer patients undergoing chemotherapy.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
سودابه شهید ثالث
Street address
Omid Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
931991358
Phone
+98 51 3551 0790
Fax
+98 930 283 4306
Email
raeem4002@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoume Sarbaz DinAbadi
Street address
Ferdowsi university, Factualy paramedicidne
City
Mashhad
Province
Razavi Khorasan
Postal code
9351991352
Phone
+98 915 519 9599
Email
msarbaz2006@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Masoume Sarbaz DinAbadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Ferdowsi university, Factualy paramedicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9351991358
Phone
+98 915 519 9599
Email
sarbazm2006@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marziyeh Raei Mehne
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Health information technology
Street address
ferdowsi university
City
mashhad
Province
Razavi Khorasan
Postal code
9351991358
Phone
+98 51 3551 0790
Email
raeem4002@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Marziyeh Raei Mehne
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Health information technology
Street address
Ferdowsi University-Faculty of paramedicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9351991358
Phone
+98 51 3551 0790
Email
Raeem4002@mums.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
No - There is not 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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