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

Medicos e Investigadores en la Lucha contra el Cancer de Mama

Status: Completed

Conditions: Breast Cancer; Patient Satisfaction; Patient Empowerment; Knowledge, Attitudes, Practice

Treatments: Other: Customizable support material; Other: Non-customizable support material

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05798312

IMAP-CM

Details and patient eligibility

About

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.

Full 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).

Enrollment: 125 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group will receive customizable support material.

Treatment:

Other: Customizable support material

Standard group

Sham Comparator group

Description:

The standard group will receive a non-customizable support material.

Treatment:

Other: Non-customizable support material