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| ID | Type | Description | Link |
|---|---|---|---|
| 2024/09-23 | Other Identifier | Dokuz Eylul University Ethics Committee | |
| TDK-2025-3605 | Other Identifier | Dokuz Eylul University Scientific Research Projects Coordination Unit (BAP) |
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| Name | Class |
|---|---|
| Dokuz Eylul University | OTHER |
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This randomized controlled trial aims to assess the effectiveness of a mobile application-based education program, developed according to Orem's Self-Care Model, in improving self-care agency and quality of life among patients with multiple myeloma in Turkey. Participants are recruited from the outpatient clinic of a hospital and randomly assigned to either the intervention or control group. The intervention group uses the mobile application for 24 weeks, while the control group continues with routine care and receives a standard one-page brochure commonly distributed to cancer patients. All participants complete a demographic form, the EORTC QLQ-C30, QLQ-MY20, and the Self-Care Agency Scale at baseline, week 12, and week 24. The collected data will be used to compare changes in self-care agency and quality of life between the two groups over time.
This study was conducted to address the self-care needs of patients diagnosed with multiple myeloma, a chronic and complex hematologic cancer. Based on Orem's Self-Care Deficit Nursing Theory, a mobile application was developed to improve patients' self-care agency and quality of life. The intervention group uses the mobile application for 24 weeks, which includes educational content, self-monitoring features, and motivational messages. The control group receives routine care, which includes standard medical follow-up and a one-page general information brochure commonly provided to cancer patients at the hospital. Self-care agency and quality of life are assessed using the Self-Care Agency Scale, EORTC QLQ-C30, and EORTC QLQ-MY20 at three time points: baseline, week 12, and week 24. The results are expected to contribute to evidence-based self-care interventions for patients with hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | A mobile application was provided to support self-care and quality of life, based on Orem's Self-Care Deficit Model. Patients were asked to use it regularly for 24 weeks. |
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| Control Group | No Intervention | Participants received routine care and a one-page standard information brochure for cancer patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile App Education | Behavioral | A 24-week self-care education delivered via a mobile application based on Orem's Self-Care Model |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Care Agency Score | Self-care agency was assessed using the Self-Care Agency Scale. | Baseline, 12th week, and 24th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dokuz | Izmir | 35340 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34939484 | Background | Hartweg DL, Metcalfe SA. Orem's Self-Care Deficit Nursing Theory: Relevance and Need for Refinement. Nurs Sci Q. 2022 Jan;35(1):70-76. doi: 10.1177/08943184211051369. | |
| 27025228 | Background | Kayser L, Kushniruk A, Osborne RH, Norgaard O, Turner P. Enhancing the Effectiveness of Consumer-Focused Health Information Technology Systems Through eHealth Literacy: A Framework for Understanding Users' Needs. JMIR Hum Factors. 2015 May 20;2(1):e9. doi: 10.2196/humanfactors.3696. |
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The individual participant data (IPD) will not be shared due to ethical constraints and participant confidentiality concerns in accordance with institutional review board (IRB) approval.
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Two-group parallel design. Participants were randomly assigned to either the intervention group, which received a mobile application-based educational program for 24 weeks, or the control group, which received routine care and a standard brochure.
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Participants were blinded to their group assignment. The investigator was aware of group allocation, as the study is a doctoral thesis project.
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |