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临床试验/NCT05798312
NCT05798312已完成不适用

Randomized and Multicenter Study to Evaluate the Impact of a Customizable Support Material in the Knowledge and Satisfaction of Breast Cancer Patients

Medicos e Investigadores en la Lucha contra el Cancer de Mama2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2021年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
试验地点
2
主要终点
Knowledge

研究概览

简要总结

The goal of this clinical trial is to evaluate if a customizable support material allows to improve the knowledge about the stage and subtype of the disease, as well as the indicated treatments, in comparison with a non-customizable support material among patients with breast cancer.

The main question it aims to answer is:

• What is the impact of delivering a customizable support material so that patients with breast cancer know and remember the stage and subtype of their disease, as well as the indicated treatments, compared to non-customizable support material?

Participants in the intervention group will be provided customizable support material while those in the standard group will receive a non-customizable material.

详细描述

In the present investigation, it is planned to carry out a prospective, multicenter study, randomized and blinded to the statistician. Patients with a recent diagnosis of CM and who are scheduled to have their first consultation in which their options will be discussed of treatment to participate in the study. To those who agree to participate and sign the informed consent, the protocol coordinator of each center will randomly assign them to the intervention group or the standard group (in a 1:1 ratio) before the appointment medical. The intervention group will receive customizable support material while the Standard group will receive a non-customizable material (Annex 2). Additionally, you will be instructed to the intervention group that the support material received can be filled with the information discussed with the medical team. The protocol coordinator will obtain sociodemographic data and clinicopathology of the medical records of the participants. After the next visit follow-up, the coordinator will apply to both groups questionnaires about the knowledge of the patient about his own disease, satisfaction with the support material received and perceived ability to participate in discussions about their treatment, and the comprehension of written materials (CHLT-6). After one month, both groups will respond knowledge questionnaires to assess long-term information retention, disease uncertainty (SF-MUIS) and satisfaction with medical information provided (EORTC-QLQ-INFO25).

研究设计

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

盲法说明

Paticipants will receive a support material with information about breast cancer. Those in the intervention group will not know of the existence of a non-customizable material and those in the standard group will not know of the existence of a customizable material.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women with a recent diagnosis of primary breast cancer treated at the participant centers
  • Women who will receive information about their options for the first time treatment
  • Provision of informed consent to participate in the study

排除标准

  • Patients who have already started systemic treatment for breast cancer
  • Patients with medical records not available for data collection

结局指标

主要结局

Knowledge

时间窗: 1-month

Evaluate if a customizable support material allows to improve the knowledge about the stage and subtype of the disease, as well as the indicated treatments, in comparison with a non-customizable support material as measured by the knowledge questionnaire assessing patients' knowledge of their disease extension (in situ vs invasive cancer); clinical stage; estrogen, progesterone and HER2 receptor status; and treatments to which they are candidates.

次要结局

  • Patient satisfaction(1-month)
  • Comprehension(1-month)
  • Satisfaction with medical information(1-month)
  • Illness uncertainty(1-month)

研究者

发起方
Medicos e Investigadores en la Lucha contra el Cancer de Mama
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Villarreal Garza

MD, DSc

Medicos e Investigadores en la Lucha contra el Cancer de Mama

研究点 (2)

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