Clinical trial NCT05798312: Randomized and Multicenter Study to Evaluate a Customizable Support Breast Cancer Material
Official title: Randomized and Multicenter Study to Evaluate the Impact of a Customizable Support Material in the Knowledge and Satisfaction of Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Knowledge, Attitudes, Practice
Patient Empowerment
Patient Satisfaction
Keywords: breast cancer
patient education
written information
shared decision making
Latin America
Lead sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2023-04-04
Enrollment: 125
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will receive customizable support material while the standard group will receive a non-customizable material.
Primary purpose: OTHER

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge
timeFrame: 1-month
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1-month
measure: Comprehension
timeFrame: 1-month
measure: Satisfaction with medical information
timeFrame: 1-month
measure: Illness uncertainty
timeFrame: 1-month
Other outcomes:
Locations:
city: San Pedro Garza Garcia
country: Mexico
facility: Hospital Zambrano Hellion
state: Nuevo Leon
Study officials:
References: