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临床试验/NCT05100498
NCT05100498已完成不适用

Web-based Oncofertility Support Tool for Reproductive-age Women With Breast Cancer

Mackay Medical College1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年1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
54
试验地点
1
主要终点
Degree of social support rated before and after using the web-based tool by patients

研究概览

简要总结

The aim of this study was to develop electronic systems (e-systems) for oncofertility support, and to examine the comprehensibility, feasibility, usability, and effects on social support and preparation for decision-making.

详细描述

Background: When reproductive-aged women with breast cancer lack support in making decisions about fertility, this results in conflicts in decision-making with negative effects on their mental health.

Objective

The aim of this study was to develop electronic systems (e-systems) for oncofertility support, and to examine the comprehensibility, feasibility, usability, and effects on social support and preparation for decision-making.

Methods: The study steps were guided, tested, and utilized to (a) identify the requirements of a patient, (b) guide the development of support interventions, and (c) evaluate the quality of web-based oncofertility support. Both qualitative and quantitative data were collected to explore supportive requirements related to oncofertility care, and an initial website concerning oncofertility was developed based on the resulting requirements and system review regarding social support. Alpha testing and beta testing were used to ensure the quality of the web-based oncofertility support tool. The effectiveness was evaluated using the Preparation for Decision-Making Scale and Social Support Questionnaire.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Health provider who ever cared the patients with breast cancer.
  • •Patients with breast cancer aged between 20 and 45.

排除标准

  • •Patients of severe psychiatric disorders.
  • •Patients under 20 years old.

研究组 & 干预措施

Web-based oncofertility support tool

Experimental

User-centered design practices were used to develop an oncofertility support website for women with breast cancer before treatment. The steps of the Ottawa Decision Support Framework were used throughout the development process. A multidisciplinary steering group was assembled, and the input was provided. Guidelines from the International Patient Decision Aid Standards were applied to test the quality of the oncofertility support website.

Three steps included:

  1. Identify the supportive needs of a patient;
  2. Guide the development of support interventions;
  3. Evaluate the quality of web-based oncofertility support.

干预措施: Web-based oncofertility support tool (Device)

结局指标

主要结局

Degree of social support rated before and after using the web-based tool by patients

时间窗: 4 months

Social support was measured using a 16-item Likert-type questionnaire rating (from 0-3). Women of reproductive age were instructed to complete the social support questionnaire, assessing four dimensions of social support: emotional, informational, appraisal, and instrumental, before and after using the web-based tool.

次要结局

  • Preparation for Decision Making (PrepDM) evaluated by patients and healthcare providers(4 months)

研究者

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

Chin-Tsung Shen

Mackay Medical College

Mackay Medical College

研究点 (1)

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