- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04914780
The Effect of Training Given by Mobile Application to Women Undergoing Breast Surgery
The Effect of Training Performed Using Mobile Application on Care Requirements and Quality of Life in Women With Breast Cancer: Randomized Controlled Trial
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Konya, Turkey
- Necmettin Erbakan University Medical Faculty Hospital Oncology Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age and over,
- Breast Conserving Surgery is applied,
- Only diagnosed with breast cancer and not having metastases,
- Participating voluntarily in the research,
- Signed the informed consent form,
- Patients who have a smart phone on them or near them will be included in the study.
Exclusion Criteria:
- Not operated after the diagnosis of breast cancer and / or surgery other than Breast Conserving Surgery,
- Another type of cancer other than breast cancer,
- Having a disability to answer questions such as dementia, Alzheimer's, hearing and vision loss,
- Illiterate,
- Do not have a smart phone and / or do not know how to use it,
- Patients in the terminal period will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
4 weeks training with mobile application
|
Education intervention with mobile application for 4 weeks
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No Intervention: Control group
No intervention will be made for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in supportive care needs at 4 weeks and 8 weeks
Time Frame: Baseline, 4 weeks and 8 weeks
|
After the training given by the mobile application, the supportive care needs scores of the patients are checked. It has been stated that the DBGÖ-SF is a measurement tool with sufficient validity and reliability indicators. Your scale; There are 9 items in the "spiritual / psychological" sub-dimension and the minimum score from this dimension is 9; maximum score is 45. There are 10 items in the "Health system and information dimension" and the minimum score obtained from this dimension is 10; maximum score is 50. There are 5 items in the "Physical and daily life" dimension and the minimum score obtained from this dimension is 5; maximum score is 25. There are 4 items in the "patient care and support" dimension and the minimum score obtained from this dimension is 4; maximum score is 20. There are 3 items in the "sexuality" dimension and the minimum score obtained from this dimension is 3; maximum score is 15. |
Baseline, 4 weeks and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in life quality at 4 weeks and 8 weeks
Time Frame: Baseline, 4 weeks and 8 weeks
|
The quality of life scores of the patients are checked after the training given with the mobile application. Each area is calculated over a maximum of 20 points or 100 points. Which of these ratings will be used depends on the researcher. Calculations over 20 points are more commonly used in our country. The higher the score on the scale, the higher the quality of life. The correlation coefficients of the scale range between 0.49 and 0.78 (14th and 17th questions). When the Cronbach's alpha values are defined as values reflecting the homogeneity of the question scores with the field scores, the internal consistency of the sections and fields of WHOQOL-BREF (TR) was found to be quite high. |
Baseline, 4 weeks and 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KaratayUHaticeTEZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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