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Completed

NCT Number: NCT06839183

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

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.

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Key information

Conditions

Mobile Health Application Hematopoietic Stem Cell Transplantations Resilience Self Efficacy Self-Compassion

Age range

47 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University

Kaohsiung City, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

integrated interactive self-care APP

Device

integrated interactive self-care APP

Primary outcomes

  1. 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."

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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