Clinical trial NCT06839183: Develop and Evaluate of Integrated Interactive Self-care APP Among Hematopoietic Stem Cell Transplantation Patient
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobile Health
Application
Hematopoietic Stem Cell Transplantations
Self-compassion
Resilience
Self Efficacy
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 47
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Conscious, over 20 years old, and able to communicate in Mandarin or Taiwanese dialect.
2. Diagnosed via pathology report with one of the following cancers: acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin lymphoma, or multiple myeloma.
3. Requires HSCT (Hematopoietic Stem Cell Transplantation) treatment.
4. Possesses a smartphone.

Exclusion Criteria:

* All mental disorders as classified in the DSM-IV.

Primary outcomes:
measure: self-efficacy
timeFrame: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
measure: self-compassion
timeFrame: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
measure: resilience
timeFrame: Transplant Day 0 (T1), Day 7 (T2), Day 14 (T3), Day 30 (T4), Day 60 (T5), Day 90 (T6), Day 120 (T7).
measure: Usability assessments
timeFrame: Immediately after app intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
References: