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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Patient Satisfaction; Knowledge, Attitudes, Practice; Patient Empowerment
• Intervention / Treatment: Other: Customizable support material; Other: Non-customizable support 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).

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
      • Hospital Zambrano Hellion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention group will receive customizable support material.	Other: Customizable support material; Customizable support material will enable patients to identify their personal breast cancer information.
Sham Comparator: Standard group; The standard group will receive a non-customizable support material.	Other: Non-customizable support material; Non-customizable support material will include general breast cancer information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge	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.	1-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Assess patient satisfaction with the written information provided and the perception of their ability to actively participate in discussions about the treatment when offered a customizable educational brochure and compare it to the patients receiving a non-customizable brochure	1-month
Comprehension	Determine if the comprehension of written materials (customizable or not customizable) is associated with the level of health literacy (Health Literacy) as measured by the Cancer Health Literacy Test - 6 (CHLT-6) instrument	1-month
Satisfaction with medical information	To determine if satisfaction with medical information is higher when offered a customizable vs. non-customizable educational brochure as per measured by the European Organization for Research and Treatment of Cancer test Quality of Life Group information questionnaire (EORTC QLQ-INFO 25)	1-month
Illness uncertainty	Determine if the uncertainty of the disease with the medical information is lower when offered a customizable educational brochure versus offering non-customizable material, as measured by the short form of Mishel Uncertainty Illness Scale (SF-MUIS)	1-month

Collaborators and Investigators

• Sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama
• Collaborators: Roche Pharma AG

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): March 13, 2022
• Study Completion (Actual): March 13, 2022

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; patient education; shared decision making; Latin America; written information
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IMAP-CM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No