NCT07088783

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

July 19, 2025

Last Update Submit

July 19, 2025

Conditions

Multiple Myeloma (MM)Self-careQuality of Life

Keywords

Multiple MyelomaOrem's Self-Care ModelMobile Health EducationQuality of LifeSelf-Care Agency

Outcome Measures

Primary Outcomes (1)

  • Change in Self-Care Agency Score

    Self-care agency was assessed using the Self-Care Agency Scale.

    Baseline, 12th week, and 24th week

Study Arms (2)

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.

Behavioral: Mobile App Education

Control Group

NO INTERVENTION

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

Interventions

Mobile App EducationBEHAVIORAL

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

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 34939484BACKGROUND

  • 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.

    PMID: 27025228BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to their group assignment. The investigator was aware of group allocation, as the study is a doctoral thesis project.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Faculty of Nursing, Dokuz Eylul University

Study Record Dates

First Submitted

July 19, 2025

First Posted

July 28, 2025

Study Start

June 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)