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临床试验/NCT07196488
NCT07196488招募中不适用

Development and Exploring the Efficacy of a Dyadic Co-learning Intervention for Patients With Prostate Cancer and Their Spouses

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年10月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Family Resilience (patients and spouses)

研究概览

简要总结

This study aims to help patients with prostate cancer and their spouses cope better with the challenges of cancer by learning and supporting each other together. The investigators will test an 8-week "Dyadic Co-learning Intervention," which includes weekly learning topics, a mobile app, and professional support. The goal is to improve their physical symptoms, emotional well-being, and resilience.

Participants will be randomly assigned to one of two groups. One group will receive regular care, while the other group will receive regular care plus the new co-learning program. The investigators will ask both patients and their spouses to complete questionnaires at the beginning of the study, and again at 10 and 16 weeks, to understand how the program affects their health and well-being.

详细描述

Objective:

To evaluate the effectiveness of a Dyadic Co-learning Intervention for patients with prostate cancer and their spouses, focusing on physical symptoms, emotional well-being, and resilience.

Study Design:

An experimental, two-group, randomized controlled design will be adopted. Participants will be recruited through convenience sampling from the urology outpatient department and inpatient wards of a hospital. Patients diagnosed with prostate cancer and their cohabiting spouses who agree to participate will provide written informed consent prior to data collection.

Procedures:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For Patients:
  • Diagnosed with prostate cancer by a board-certified urologist.
  • Has either decided on a treatment plan or completed treatment within the past two years.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
  • For Spouses:
  • Must be a cohabiting spouse of the prostate cancer patient and aged 20 years or older.
  • Must have a Barthel Index score of 91 or above, indicating good functional independence.

排除标准

  • Either the patient or the spouse will be excluded if:
  • Diagnosed with another type of cancer.
  • Diagnosed with cognitive impairment or a psychiatric disorder, such as dementia, depression, or anxiety.

研究组 & 干预措施

Control Group

No Intervention

Participants in the control group will receive routine care.

Dyadic Co-learning Intervention Group

Experimental

Participants in the experimental group will receive routine care plus an 8-week Dyadic Co-learning Intervention.

干预措施: Dyadic Co-learning Intervention (Other)

结局指标

主要结局

Family Resilience (patients and spouses)

时间窗: Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test

This study will adopt the Chinese version of the Walsh Family Resilience Questionnaire to assess family resilience in patients with prostate cancer and their spouses. The scale uses a 5-point Likert rating, ranging from 1 (Never) to 5 (Always). Total scores range from 26 to 130, with higher scores indicating greater levels of family resilience.

次要结局

  • Physical Symptoms and Distress (patients only)(Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test)
  • Resilience (patients and spouses)(Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test)
  • Subjective Well-Being (patients and spouses)(Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test)
  • Fatigue (patients only)(Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test)
  • Loneliness (patients and spouses)(Before the intervention (pre-test), and at the 10th and 16th weeks after the pre-test)
  • Intervention Satisfaction (patients and spouses in intervention group)(10th weeks after the pre-test)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ching-Hui Chien

RN, PhD, Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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