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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2022-03-13

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer Knowledge, Attitudes, Practice Patient Empowerment Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Intervention group

The intervention group will receive customizable support material.

Group Type EXPERIMENTAL

Customizable support material

Intervention Type OTHER

Customizable support material will enable patients to identify their personal breast cancer information.

Standard group

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

Group Type SHAM_COMPARATOR

Non-customizable support material

Intervention Type OTHER

Non-customizable support material will include general breast cancer information.

Interventions

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Customizable support material

Customizable support material will enable patients to identify their personal breast cancer information.

Intervention Type OTHER

Non-customizable support material

Non-customizable support material will include general breast cancer information.

Intervention Type OTHER

Eligibility Criteria

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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