UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048955 |
|---|---|
| Receipt number | R000055389 |
| Scientific Title | Nurse versus Chatbot: Effect of Empowerment Program on Chemotherapy Related Side Effects and Self-Care Behaviors of breast cancer women - RCT. |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2022/09/26 08:50:02 |
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Basic information
Public title
Nurse versus Chatbot- Effect of Empowerment Program on Chemotherapy Related Side Effects and Self-Care Behaviors of breast cancer women: A Randomized Controlled Trial
Acronym
Nurse versus Chatbot- Effect of Empowerment Program on Chemotherapy Related Side Effects and Self-Care Behaviors of breast cancer women: A Randomized Controlled Trial
Scientific Title
Nurse versus Chatbot: Effect of Empowerment Program on Chemotherapy Related Side Effects and Self-Care Behaviors of breast cancer women - RCT.
Scientific Title:Acronym
Nurse versus Chatbot- Effect of Empowerment Program on Chemotherapy Related Side Effects and Self-Care Behaviors of breast cancer women: A Randomized Controlled Trial
Region
| Africa |
Condition
Condition
Nursing study
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
test whether the empowerment intervention (chatbot, and nurse-led education) is effective, compared with a control group
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Chemotherapy Related Side Effects
Self-Care Behaviors
Key secondary outcomes
Usability of Chatbot
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
use of Chatbot for 3 months at their own pace and when needed
Interventions/Control_2
Attend face three face to face sessions on the day of chemotherapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
aged 20 years or older, read & write, newly diagnosed with breast cancer, and scheduled for first or second chemotherapy session, non-metastatic cancer stage 0-III, has smart phone (personal or shared with their family members), not receiving any concurrent therapy for any chronic diseases.
Key exclusion criteria
Illiterate
Younger than 20 years
Has no smart phone
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Elham |
| Middle name | |
| Last name | Tawfik |
Organization
Damanhour University
Division name
Faculty of Nursing
Zip code
22511
Address
El gomhoureya St., beside the hospital damanhour general, damanhour, beheira. Damanhour Beheira
TEL
0020453311679
Elham@nur.dmu.edu.eg
Public contact
Name of contact person
| 1st name | Eman |
| Middle name | |
| Last name | Ghallab |
Organization
Alexandria University
Division name
Faculty of Nursing
Zip code
21568
Address
Izbat Saed, Sidi Gaber, Alexandria Governorate
TEL
002034291336
Homepage URL
eman.ghallab@alexu.edu.eg
Sponsor or person
Institute
Damnhour University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee, Faculty of Nursing, Damnhour University
Address
El gomhoureya St., beside the hospital damanhour general, damanhour, beheira. Damanhour Beheira
Tel
002045 3311679
admin.nur@nur.dmu.edu.eg
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
150
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 17 | Day |
Last modified on
| 2022 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055389
