NCT05798312

Randomized and Multicenter Study to Evaluate a Customizable Support Breast Cancer Material

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Breast Cancer
• Knowledge, Attitudes, Practice
• Patient Empowerment
• Patient Satisfaction

Interventions

Type	Name	Description
OTHER	Customizable support material	Customizable support material will enable patients to identify their personal breast cancer information.
OTHER	Non-customizable support material	Non-customizable support material will include general breast cancer information.

Timeline

• Start date: 2021-05-21
• Primary completion: 2022-03-13
• Completion: 2022-03-13
• First posted: 2023-04-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: Mexico