CancerMANNERNCT05881070
Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy
A study testing Mobile-health self management in people with Cancer and Chemotherapy Effect, run by Universitas Muhammadiyah Yogyakarta.
Trial summary
The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer, Chemotherapy Effect, Quality of Life
- What is being tested?
- Mobile-health self management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 30 Sep 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients diagnosed with cancer
- patients who use smart phone
Who cannot join
- patients with cancer with comorbidity
About this study
The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.
Read the detailed description
The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.
- Conditions
- Cancer, Chemotherapy Effect, Quality of Life, Self Efficacy
- Being tested
- Mobile-health self management
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile-health self managementBehavioural
Mobile-health self management
| Study group | Role | What they receive |
|---|---|---|
| Mobile health self-management | Experimental | Not described Receives: Behavioral: Mobile-health self management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Quality of life
The patient's quality of life will be assessed before (T0) and after intervention (T1). The measurement will use EORTC. The score will range from 0-100, where higher score reflects a better quality of life.
Measured: Four weeks
Patient's Self-efficacy
The patients self-efficacy will be measured pre and post intervention. The measurement will use the Self-Efficacy for Managing Chronic Disease Scale. The scale has been widely used in cancer setting. Respondents will rate their confidence to perform six self-management behaviours (1 = 'not at all confident' to 10 = 'totally confident'). A mean score is calculated (range 1 to 10). A high score indicates high self-efficacy.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Yogyakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erna Rochmawati, Universitas Muhammadiyah Yogyakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881070
- Sponsor's protocol ID
- Manner and QOL
- Acronym
- MANNER
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 30 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile-health Self Management on Quality of Life of Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT05881070
- Acronym / sponsor ID
- MANNER / Manner and QOL
- Conditions
- Cancer, Chemotherapy Effect, Quality of Life, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitas Muhammadiyah YogyakartaUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 30 May 2023 (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.
The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.
Detailed description
The study will design and evaluate the use of mobile-health based self-management on self-efficacy and quality of life of patients undergoing chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile health self-management | Experimental | Behavioral: Mobile-health self management |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients diagnosed with cancer
- patients who use smart phone
Key exclusion criteria (1 listed)
- patients with cancer with comorbidity
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-health self managementMobile-health self management | Behavioural | Mobile health self-management |
Primary outcome
Patient's Quality of life
Time frame: Four weeks
The patient's quality of life will be assessed before (T0) and after intervention (T1). The measurement will use EORTC. The score will range from 0-100, where higher score reflects a better quality of life.
Patient's Self-efficacy
Time frame: four weeks
The patients self-efficacy will be measured pre and post intervention. The measurement will use the Self-Efficacy for Managing Chronic Disease Scale. The scale has been widely used in cancer setting. Respondents will rate their confidence to perform six self-management behaviours (1 = 'not at all confident' to 10 = 'totally confident'). A mean score is calculated (range 1 to 10). A high score indicates high self-efficacy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile-health self management in people with Cancer and Chemotherapy Effect, run by Universitas Muhammadiyah Yogyakarta.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Patient's Quality of life (time frame: Four weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.