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临床试验/NCT06839183
NCT06839183已完成不适用

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)

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
self-efficacy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
47 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Application group

Experimental

use the integrated interactive self-care APP

干预措施: integrated interactive self-care APP (Device)

usual care group

No Intervention

usual care

结局指标

主要结局

self-efficacy

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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