Develop and Evaluate of Integrated Interactive Self-care APP Among Hematopoietic Stem Cell Transplantation Patient

NCT06839183 | Completed DMC

• 2 other identifiers: KMUHIRB-F(I)20210187MOST-111-2410-H-037-012
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Mobile Health; Application; Hematopoietic Stem Cell Transplantations; Self-compassion; Resilience; Self Efficacy

Outcome Measures

Primary Outcomes (4)

• 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."

  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.

  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.

  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.

  Immediately after app intervention.

Study Arms (2)

Application group

EXPERIMENTAL

use the integrated interactive self-care APP

Device: integrated interactive self-care APP

usual care group

NO INTERVENTION

usual care

Interventions

integrated interactive self-care APP DEVICE

integrated interactive self-care APP

Application group

Eligibility Criteria

• Age: 47 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: February 21, 2025
• Study Start: August 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2024
• Last Updated: February 21, 2025

Record last verified: 2024-11

Locations

TW (1)