Determining the effect of using colon cancer mobile application on early detection of colorectal cancer
Design
The study will be conducted as a clinical trial with a control group, with parallel groups, one-sided blind with the participation of 200 volunteers. Randomization will be done using the Study Randomizer software. [Software Application]. (2017) Available at: https://www.studyrandomizer.com
Settings and conduct
This study will be conducted in the patients of Taleghani hospital in Tehran. Clients are divided into two groups according to the inclusion criteria using colored cards. The intervention group will be provided with the necessary training on colon cancer prevention and diagnosis with software, and the control group will be taught face-to-face and pamphlets. Then, two groups will be evaluated in terms of early detection of colorectal cancer symptoms.
This study will be performed in single blind. In this way, researcher A will do the evaluation and the emergence of disease symptoms will be done by researcher B, who will be unaware of the allocation of groups. Also, the data analyst will not know about the grouping of the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a smart phone and the ability to read and write
Exclusion criteria: not wanting to install the app on your mobile phone
Intervention groups
The intervention group includes people who receive the training intervention to improve self-care ability in preventing and contracting colon cancer using the colon cancer mobile app, and the control group includes people who receive training to improve self-care ability in prevention. and get colon cancer through face-to-face education and pamphlets.
Main outcome variables
Early detection of colorectal cancer symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210131050189N9
Registration date:2024-02-13, 1402/11/24
Registration timing:prospective
Last update:2024-02-13, 1402/11/24
Update count:0
Registration date
2024-02-13, 1402/11/24
Registrant information
Name
Raziyeh Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 4520
Email address
ghafouri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of using mobile app of colon cancer on early detection of colorectal cancer
Public title
Evaluation of colon cancer mobile application on early detection of colorectal cancer
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Having a smart phone
Ability to read and write
Exclusion criteria:
Reluctance to use mobile application
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done with using study randomizer software.
Study Randomizer [Software Application]. (2017) Available at: https://www.studyrandomizer.com
After registering in the software, first the study details including the number of study groups, the number of participants are registered in the software. In the next step, a code will be assigned to each participant in the order of entering the research along with random assignment to the intervention and control group by the software. In the software, the sequence of allocation of participants is recorded. In the present study, the time of entry of each participant using this software will be used to allocate to the intervention or control group and the process will continue until the end of sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
Colorectal cancer self-care training in two groups of control (usual training) and intervention (training with software) is done by researcher A, and the evaluation of the incidence of colorectal cancer symptoms is checked by researcher B. Also, the data analyst will not know the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Sciences
Occurrence of symptoms of abdominal pain during defecation, chronic bleeding from the anus, feeling of mass in the anus, having a history of inflammatory bowel diseases, having a history of polyps and colon cancer in first degree relatives
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, using the colon cancer software prepared, they are taught about the colon, colon cancer, stages of cancer, its early symptoms, risk factors, and ways to reduce the risk of infection and screening. They are promoted in identifying early symptoms and taking care of themselves in the prevention of colorectal cancer. Also, there are two self-assessment programs in the software that users can use to assess their risk of developing colorectal cancer and give feedback based on each person's condition.
Category
Early detection
2
Description
In the control group, about colorectal cancer, the stages of colorectal cancer, its early symptoms, risk factors and ways to reduce the risk and screening are taught face-to-face and using pamphlets.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
(Ayatollah) Taleghani Educational Hospital
Full name of responsible person
Raziyeh Ghafouri
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2303 1100
Email
taleghani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zergi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Raziyeh Ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
0982188202520
Email
raziehghafouri@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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data of the current research can be shared after de-identifying the participants.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Academic researchers can use the results of the current research for retrospective research, provided they have the approval of the National Ethics Committee of Iran in the research and mention the source of the research.
From where data/document is obtainable
By email to the corresponding author
raziehghafouri@gmail.com
What processes are involved for a request to access data/document
By email to the corresponding author
raziehghafouri@gmail.com