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Mobile App Education Based on Orem's Self-Care Model in Multiple Myeloma Patients

The Effect of Mobile Application-Based Education Developed According to Orem's Self-Care Model on Enhancing Self-Care Agency in Patients With Multiple Myeloma: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07088783
Acronym
OCARE-MM
Enrollment
60
Registered
2025-07-28
Start date
2024-06-01
Completion date
2025-10-01
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma (MM), Quality of Life, Self-care

Keywords

Multiple Myeloma, Orem's Self-Care Model, Mobile Health Education, Quality of Life, Self-Care Agency

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMobile App Education

A 24-week self-care education delivered via a mobile application based on Orem's Self-Care Model

Sponsors

Dokuz Eylul University
CollaboratorOTHER
Ozlem
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Participants were blinded to their group assignment. The investigator was aware of group allocation, as the study is a doctoral thesis project.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Diagnosed with multiple myeloma and received at least one course of treatment * Age 18 or older * Able to speak and read Turkish * ECOG performance status of I, II, or III * Has used at least one Android-based digital tool (e.g., sending text messages, email, using mobile apps) * Literate (able to read and write) * Willing to participate and able to provide written informed consent

Exclusion criteria

* Not currently diagnosed with multiple myeloma * Has cognitive or psychological disorders that prevent completing questionnaires or using the mobile application * Unable to speak or understand Turkish * Unwilling or unable to provide written informed consent

Design outcomes

Primary

MeasureTime frameDescription
Change in Self-Care Agency ScoreBaseline, 12th week, and 24th weekSelf-care agency was assessed using the Self-Care Agency Scale.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026