Multiple Myeloma (MM)OCARE-MMNCT07088783
The Effect of Mobile Application-Based Education Developed According to Orem's Self-Care Model in Multiple Myeloma Patients
A study testing Mobile App Education in people with Multiple Myeloma (MM) and Self-care, run by Ozlem at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma (MM), Self-care, Quality of Life
- What is being tested?
- Mobile App Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF A MOBILE APPLICATION-BASED EDUCATION DEVELOPED ACCORDING TO OREM'S SELF-CARE MODEL ON THE IMPROVEMENT OF SELF-CARE AGENCY IN PATIENTS WITH MULTIPLE MYELOMA: A RANDOMIZED CONTROLLED TRIAL
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.
Read the 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.
- Conditions
- Multiple Myeloma (MM), Self-care, Quality of Life
- Being tested
- Mobile App Education
- Keywords
- Multiple Myeloma, Orem's Self-Care Model, Mobile Health Education, Quality of Life, Self-Care Agency
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile App EducationBehavioural
A 24-week self-care education delivered via a mobile application based on Orem's Self-Care Model
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile App Education |
| Control Group | No intervention | Participants received routine care and a one-page standard information brochure for cancer patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Care Agency Score
Self-care agency was assessed using the Self-Care Agency Scale.
Measured: Baseline, 12th week, and 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jun 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ozlem
- Sponsor type
- University, hospital or other
- Collaborators
- Dokuz Eylul University
- Responsible party
- Sponsor-investigator, Ozlem, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088783
- Sponsor's protocol ID
- DEU-MM-RCT-2024-0923
- Other IDs
- 2024/09-23, TDK-2025-3605
- Acronym
- OCARE-MM
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34939484Kayser 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.
PubMed 27025228
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF A MOBILE APPLICATION-BASED EDUCATION DEVELOPED ACCORDING TO OREM'S SELF-CARE MODEL ON THE IMPROVEMENT OF SELF-CARE AGENCY IN PATIENTS WITH MULTIPLE MYELOMA: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07088783
- Acronym / sponsor ID
- OCARE-MM / DEU-MM-RCT-2024-0923
- Conditions
- Multiple Myeloma (MM), Self-care, Quality of Life
- Keywords
- Multiple Myeloma, Orem's Self-Care Model, Mobile Health Education, Quality of Life, Self-Care Agency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- OzlemUniversity, hospital or other
- Collaborators
- Dokuz Eylul University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mobile App EducationA 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. |
| Control Group | No intervention | –Participants received routine care and a one-page standard information brochure for cancer patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile App EducationA 24-week self-care education delivered via a mobile application based on Orem's Self-Care Model | Behavioural | Intervention Group |
Primary outcome
Change in Self-Care Agency Score
Time frame: Baseline, 12th week, and 24th week
Self-care agency was assessed using the Self-Care Agency Scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Results publication: PubMed 34939484Hartweg 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.
- Results publication: PubMed 27025228Kayser 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile App Education in people with Multiple Myeloma (MM) and Self-care, run by Ozlem at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-Care Agency Score (time frame: Baseline, 12th week, and 24th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07088783, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.