Mobile HealthNCT06839183
Develop and Evaluate of Integrated Interactive Self-care APP Among Hematopoietic Stem Cell Transplantation Patient
A study testing integrated interactive self-care APP in people with Mobile Health and Application, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: More than 50,000 hematopoietic stem cell transplants are performed around the world every year. However, HSCT treatment time is long and the treatment methods are complex, and it has a significant impact on the patient's body and mind. Read more about this study
- Who is it for?
- Ages 47 years and older
- Conditions the study is for
- Mobile Health, Application, Hematopoietic Stem Cell Transplantations
- What is being tested?
- integrated interactive self-care APP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Oct 2024
- 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 47 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conscious, over 20 years old, and able to communicate in Mandarin or Taiwanese dialect.
- Diagnosed via pathology report with one of the following cancers: acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, or multiple myeloma.
- Requires HSCT (Hematopoietic Stem Cell Transplantation) treatment.
- Possesses a smartphone.
Who cannot join
- All mental disorders as classified in the DSM-IV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Develop and Evaluate the Effectiveness of Integrated Interactive Self-care APP on Self-efficacy, Self-compassion and Resilience Among Patients Undergoing Hematopoietic Stem Cell Transplantation(the Second and Third-year Mixed-method Study)
Background: More than 50,000 hematopoietic stem cell transplants are performed around the world every year. However, HSCT treatment time is long and the treatment methods are complex, and it has a significant impact on the patient's body and mind. Foreign studies have shown that using mobile technology for cancer symptom monitoring and self-care can effectively improve cancer patients' doctor-patient communication, symptom management, and self-care abilities. There are only 7 articles on foreign HSCT-related APPs or online smart projects.
Purpose: To evaluate the use of an integrated interactive self-care APP in hematopoietic stem cell transplant patients Methods: This study is a two-stage explanatory qualitative mixed study. The quantitative study in the second year adopts a non-randomized experimental research design. Pre-test and formal testing are repeated in two groups. The experimental group (APP) will be admitted first according to the patient's wishes. The number of participants will then be included in the control group. Each group is expected to receive 40 subjects. The experimental group will receive general routine care plus the use of an integrated interactive self-care APP. The control group will receive general routine care and will be filled out at 8-time points before and after transplantation. Self-efficacy, self-compassion, and resilience questionnaire.
- Conditions
- Mobile Health, Application, Hematopoietic Stem Cell Transplantations, Self-compassion, Resilience, Self Efficacy
- Being tested
- integrated interactive self-care APP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated interactive self-care APPDevice
integrated interactive self-care APP
| Study group | Role | What they receive |
|---|---|---|
| Application group | Experimental | use the integrated interactive self-care APP Receives: Device: integrated interactive self-care APP |
| usual care group | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-efficacy
Self-efficacy will be measured using the Strategies Used By People To Promote Health, SUPPH, a validated 29-item scale scored from 29 to 145, where higher scores indicate greater self-efficacy."
Measured: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
self-compassion
Self-compassion will be measured using the Self-Compassion Scale (SCS), a validated 26-item questionnaire scored from 1 to 5, where higher scores indicate greater self-compassion.
Measured: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
resilience
Resilience will be measured using the Resilience Scale 14 item (RS-14), a 14-item scale scored from 7 to 98, where higher scores indicate greater resilience.
Measured: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
Usability assessments
Usability will be measured using the System Usability Scale (SUS), a validated 10-item scale scored from 0 to 100, where higher scores indicate better usability.
Measured: Immediately after app intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Aug 2021
- Primary completion31 Jul 2022
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile HealthStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839183
- Sponsor's protocol ID
- KMUHIRB-F(I)20210187
- Other IDs
- MOST-111-2410-H-037-012
- Status last verified
- Nov 2024
- First submitted
- 18 Dec 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Develop and Evaluate the Effectiveness of Integrated Interactive Self-care APP on Self-efficacy, Self-compassion and Resilience Among Patients Undergoing Hematopoietic Stem Cell Transplantation(the Second and Third-year Mixed-method Study)
- ClinicalTrials.gov ID
- NCT06839183
- Acronym / sponsor ID
- KMUHIRB-F(I)20210187
- Conditions
- Mobile Health, Application, Hematopoietic Stem Cell Transplantations, Self-compassion, Resilience, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 21 Feb 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.
Background: More than 50,000 hematopoietic stem cell transplants are performed around the world every year. However, HSCT treatment time is long and the treatment methods are complex, and it has a significant impact on the patient's body and mind. Foreign studies have shown that using mobile technology for cancer symptom monitoring and self-care can effectively improve cancer patients' doctor-patient communication, symptom management, and self-care abilities. There are only 7 articles on foreign HSCT-related APPs or online smart projects.
Purpose: To evaluate the use of an integrated interactive self-care APP in hematopoietic stem cell transplant patients Methods: This study is a two-stage explanatory qualitative mixed study. The quantitative study in the second year adopts a non-randomized experimental research design. Pre-test and formal testing are repeated in two groups. The experimental group (APP) will be admitted first according to the patient's wishes. The number of participants will then be included in the control group. Each group is expected to receive 40 subjects. The experimental group will receive general routine care plus the use of an integrated interactive self-care APP. The control group will receive general routine care and will be filled out at 8-time points before and after transplantation. Self-efficacy, self-compassion, and resilience questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application group | Experimental | Device: integrated interactive self-care APPuse the integrated interactive self-care APP |
| usual care group | No intervention | –usual care |
Who may qualify
- Ages
- 47 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Conscious, over 20 years old, and able to communicate in Mandarin or Taiwanese dialect.
- Diagnosed via pathology report with one of the following cancers: acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, or multiple myeloma.
- Requires HSCT (Hematopoietic Stem Cell Transplantation) treatment.
- Possesses a smartphone.
Key exclusion criteria (1 listed)
- All mental disorders as classified in the DSM-IV.
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 |
|---|---|---|
| integrated interactive self-care APPintegrated interactive self-care APP | Device | Application group |
Primary outcome
self-efficacy
Time frame: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
Self-efficacy will be measured using the Strategies Used By People To Promote Health, SUPPH, a validated 29-item scale scored from 29 to 145, where higher scores indicate greater self-efficacy."
self-compassion
Time frame: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
Self-compassion will be measured using the Self-Compassion Scale (SCS), a validated 26-item questionnaire scored from 1 to 5, where higher scores indicate greater self-compassion.
resilience
Time frame: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
Resilience will be measured using the Resilience Scale 14 item (RS-14), a 14-item scale scored from 7 to 98, where higher scores indicate greater resilience.
Usability assessments
Time frame: Immediately after app intervention.
Usability will be measured using the System Usability Scale (SUS), a validated 10-item scale scored from 0 to 100, where higher scores indicate better usability.
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 Feb 2025.
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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 integrated interactive self-care APP in people with Mobile Health and Application, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 21 Feb 2025. 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 Taiwan. 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?
self-efficacy (time frame: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).). The study lists 4 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 21 Feb 2025.