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

NCT ID: NCT07088783

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma (MM) Self-care Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

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

Study Groups

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Intervention Group

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.

Group Type EXPERIMENTAL

Mobile App Education

Intervention Type BEHAVIORAL

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

Control Group

Participants received routine care and a one-page standard information brochure for cancer patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile App Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role collaborator

Ozlem

OTHER

Sponsor Role lead

Responsible Party

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Ozlem

Professor, Faculty of Nursing, Dokuz Eylul University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Dokuz

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 34939484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27025228 (View on PubMed)

Other Identifiers

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2024/09-23

Identifier Type: OTHER

Identifier Source: secondary_id

TDK-2025-3605

Identifier Type: OTHER

Identifier Source: secondary_id

DEU-MM-RCT-2024-0923

Identifier Type: -

Identifier Source: org_study_id

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